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evaluate the safety and effectiveness of the Lotus \\({ }^{\\text {TM }}\\) Valve System and LOTUS Edge \\({ }^{\\text {TM }}\\) Valve System for transcatheter aortic valve replacement (TAVR) in symptomatic subjects with calcific, severe native aortic stenosis who are considered at extreme or high risk for surgical valve replacement.","text_display":"To evaluate the safety and effectiveness of the Lotus \\({ }^{\\text {TM }}\\) Valve System and LOTUS Edge \\({ }^{\\text {TM }}\\) Valve System for transcatheter aortic valve replacement (TAVR) in symptomatic subjects with calcific, severe native aortic stenosis who are considered at extreme or high risk for surgical valve 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Valve System and LOTUS Edge Valve System consisting of two main components: \\\\\n- a bioprosthetic bovine pericardial aortic valve, and \\\\\n- a delivery system. \\\\\nDevices sizes for the Lotus Valve System include \\(21 mm, 23 mm, 25 mm\\), and 27 mm diameter. \\\\\nDevice sizes for the LOTUS Edge Valve System include \\(23 mm, 25 mm\\), 27 mm and 29 mm diameter. \\\\\nNote: LOTUS Edge is a design iteration of the Lotus Valve System. 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Randomized Clinical Evaluation} \\\\\n\\hline & \\begin{tabular}{l}\nwhere the implant procedure is being performed. \\\\\nNote 2: A center may use the CoreValve \\({ }^{\\circledR}\\) Evolut \\({ }^{\\text {TM }}\\) R Recapturable TAVR System with the aforementioned size matrix if it is approved and commercially available, but only if the center no longer has access to CoreValve.\n\\end{tabular} \\\\\n\\hline Study Design & \\begin{tabular}{l}\nREPRISE III is designed to evaluate the safety and effectiveness of the Lotus Valve System and LOTUS Edge Valve System for TAVR in symptomatic subjects who have calcific, severe native aortic stenosis and who are at high or extreme risk for surgical aortic valve replacement (SAVR). Study cohorts include the following. \\\\\n- A prospective, multicenter, 2:1 randomized (Lotus Valve System [ \\(23 mm, 25 mm\\), and 27 mm valve sizes] versus a commercially available CoreValve Transcatheter Aortic Valve Replacement System [ \\(26 mm, 29 mm\\), and 31 mm valve sizes]), controlled trial \\\\\n- A non-randomized roll-in phase with only the test device ( 23 mm , 25 mm , and 27 mm valve sizes) for centers that do not have previous experience implanting the Lotus valve; each of these centers will perform at least 2 roll-in cases before commencing randomization. Data from roll-in subjects will be summarized separately from the randomized population. \\\\\n- A non-randomized, nested registry cohort of subjects who will receive the 21 mm Lotus Valve (Lotus 21 mm Nested Registry). Participating centers will be centers that have enrolled subjects in REPRISE III. \\\\\n- An additional cohort of subjects who will receive the Lotus Valve ( \\(23 mm, 25 mm\\), and 27 mm valve sizes) beginning after enrollment of the randomized cohort is completed (U.S. Continued Access Study cohort). This cohort will be used to further assess performance and safety. Participating centers will be United States centers that have enrolled subjects in REPRISE III. Selected centers with the ability to perform high quality 4D computed tomography (CT) scans will include U.S. Continued Access Study subjects in a CT Imaging Substudy to assess the prevalence of reduced leaflet mobility and its relationship, if any, to clinical events. \\\\\n- A non-randomized, nested registry cohort of subjects who will receive the \\(23 mm, 25 mm\\) or 27 mm LOTUS Edge Valve (LOTUS Edge Nested Registry). Participating centers will be centers that have\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|}\n\\hline \\multicolumn{2}{|c|}{REPRISE III: REpositionable Percutaneous Replacement of Stenotic Aortic Valve through Implantation of Lotus \\({ }^{\\text {TM }}\\) Valve System - Randomized Clinical Evaluation} \\\\\n\\hline & \\begin{tabular}{l}\nwhere the implant procedure is being performed. \\\\\nNote 2: A center may use the CoreValve \\({ }^{\\circledR}\\) Evolut \\({ }^{\\text {TM }}\\) R Recapturable TAVR System with the aforementioned size matrix if it is approved and commercially available, but only if the center no longer has access to CoreValve.\n\\end{tabular} \\\\\n\\hline Study Design & \\begin{tabular}{l}\nREPRISE III is designed to evaluate the safety and effectiveness of the Lotus Valve System and LOTUS Edge Valve System for TAVR in symptomatic subjects who have calcific, severe native aortic stenosis and who are at high or extreme risk for surgical aortic valve replacement (SAVR). Study cohorts include the following. \\\\\n- A prospective, multicenter, 2:1 randomized (Lotus Valve System [ \\(23 mm, 25 mm\\), and 27 mm valve sizes] versus a commercially available CoreValve Transcatheter Aortic Valve Replacement System [ \\(26 mm, 29 mm\\), and 31 mm valve sizes]), controlled trial \\\\\n- A non-randomized roll-in phase with only the test device ( 23 mm , 25 mm , and 27 mm valve sizes) for centers that do not have previous experience implanting the Lotus valve; each of these centers will perform at least 2 roll-in cases before commencing randomization. Data from roll-in subjects will be summarized separately from the randomized population. \\\\\n- A non-randomized, nested registry cohort of subjects who will receive the 21 mm Lotus Valve (Lotus 21 mm Nested Registry). Participating centers will be centers that have enrolled subjects in REPRISE III. \\\\\n- An additional cohort of subjects who will receive the Lotus Valve ( \\(23 mm, 25 mm\\), and 27 mm valve sizes) beginning after enrollment of the randomized cohort is completed (U.S. Continued Access Study cohort). This cohort will be used to further assess performance and safety. Participating centers will be United States centers that have enrolled subjects in REPRISE III. Selected centers with the ability to perform high quality 4D computed tomography (CT) scans will include U.S. Continued Access Study subjects in a CT Imaging Substudy to assess the prevalence of reduced leaflet mobility and its relationship, if any, to clinical events. \\\\\n- A non-randomized, nested registry cohort of subjects who will receive the \\(23 mm, 25 mm\\) or 27 mm LOTUS Edge Valve (LOTUS Edge Nested Registry). 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III is designed to evaluate the safety and effectiveness of the Lotus Valve System and LOTUS Edge Valve System for TAVR in symptomatic subjects who have calcific, severe native aortic stenosis and who are at high or extreme risk for surgical aortic valve replacement (SAVR). 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Randomized Clinical Evaluation} \\\\\n\\hline & \\begin{tabular}{l}\nstudy performed will be used for analysis. \\\\\nNote 4: For subjects diagnosed with a neurological event (e.g., stroke, transient ischemic attack), a neurological physical exam (conducted by a neurologist, neurology fellow, neurology physician assistant, or neurology nurse practitioner), NIHSS assessment, and mRS must be performed after the event; mRS must also be administered \\(90 \\pm 14\\) days post-neurological event. \\\\\na: Kappetein AP, et al. J Am Coll Cardiol. 2012;60:1438 \\\\\nb: Leon M, et al. J Am Coll Cardiol. 2011;57:253\n\\end{tabular} \\\\\n\\hline Follow-up Schedule & All subjects implanted with a test or control device will be assessed at baseline, peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 days, 6 months, 1 year, and then annually for up to 5 years post-procedure. Subjects who are enrolled but not implanted with a test or control device at the time of the procedure will be followed for safety through 1 year. \\\\\n\\hline Study Duration & Subjects implanted with a test or control device will be followed for 5 years after the procedure. \\\\\n\\hline Adjunctive Pharmacologic Therapy & \\begin{tabular}{l}\nAnticoagulant Therapy \\\\\nAnticoagulant therapy (e.g., unfractionated heparin) per local standard of care must be administered during the implant procedure, with a recommended target activated clotting time of \\(\\geq 250\\) seconds during the index procedure. \\\\\nAnti-Platelet Therapy \\\\\nPer society guidelines \\({ }^{ c }\\), antiplatelet therapy with aspirin and clopidogrel \\({ }^{ d }\\) is recommended after TAVR to decrease the risk of thrombotic or thromboembolic complications if there are no contraindications to these medications. \\\\\nAspirin \\\\\nA loading dose of aspirin (recommended dose of \\(75-325 mg\\) ) is required for subjects who have not been taking aspirin for \\(\\geq 72\\) hours at the time of the index procedure. 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Subjects who are enrolled but not implanted with a test or control device at the time of the procedure will be followed for safety through 1 year.","text_display":"All subjects implanted with a test or control device will be assessed at baseline, peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 days, 6 months, 1 year, and then annually for up to 5 years post-procedure. 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The loading dose must be administered prior to the implant procedure. \\\\\nAfter the valve implant procedure, clopidogrel \\({ }^{\\text {d }}\\) (recommended dose of 75 mg daily) is required for at least 1 month. \\\\\nNote: If a subject requires chronic anticoagulation, either clopidogrel or aspirin is required prior to and after the implant procedure in addition to the anticoagulant therapy (but both aspirin and clopidogrel are not required). After the implant procedure, the subject must be treated with warfarin (other anticoagulants are not permitted in the first month) and either clopidogrel (other \\({ P 2 Y _{12}}\\) inhibitors are not permitted in combination with warfarin) or aspirin for at least 1 month. After 1 month, subjects requiring chronic anticoagulation may be switched from warfarin to a new oral anticoagulant (NOAC) at the discretion of the treating physician. The subject should not receive a \\(P 2 Y _{12}\\) inhibitor in combination with a NOAC but may be treated with a NOAC plus aspirin. \\\\\nc: Holmes, D. R., et al. J Am Coll Cardiol. 2012;59:1200-1254 \\\\\nNishimura, R., et al. J Am Coll Cardiol. 2014;63:2438-88 \\\\\nd: An alternative \\({ P 2 Y _{12}}\\) inhibitor may be prescribed if subject is allergic to or intolerant of clopidogrel.\n\\end{tabular} \\\\\n\\hline Inclusion Criteria & \\begin{tabular}{l}\nIC1. Subject has documented calcific, severe native aortic stenosis with an initial AVA of \\(\\leq 1.0 cm^{2}\\) (or AVA index of \\(\\leq 0.6 cm^{2} / m ^{2}\\) ) and a mean pressure gradient \\(\\geq 40 mm Hg\\) or jet velocity \\(\\geq 4.0 m / s\\), as measured by echocardiography and/or invasive hemodynamics. \\\\\nIC2. Subject has a documented aortic annulus size of \\(\\geq 18 mm\\) and \\(\\leq 29 mm\\) based on the center's assessment of pre-procedure diagnostic imaging (and confirmed by the Case Review Committee [CRC]) and, for the randomized cohort, is deemed treatable with an available size of both test and control device. For the U.S. Continued Access Study cohort the acceptable aortic annulus size is \\(\\geq 20 mm\\) and \\(\\leq 27 mm\\). \\\\\nIC3. Subject has symptomatic aortic valve stenosis with NYHA Functional Class \\(\\geq\\) II. \\\\\nIC4. There is agreement by the heart team (which must include a site investigator interventionalist and a site investigator cardiac surgeon)\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|}\n\\hline \\multicolumn{2}{|c|}{REPRISE III: REpositionable Percutaneous Replacement of Stenotic Aortic Valve through Implantation of Lotus \\({ }^{\\text {TM }}\\) Valve System - Randomized Clinical Evaluation} \\\\\n\\hline & \\begin{tabular}{l}\naspirin be given indefinitely thereafter as per local standard of care. \\\\\nClopidogrel \\\\\nA loading dose of clopidogrel (recommended dose of \\(\\geq 300 mg\\) ) is required for subjects who have not been taking clopidogrel for \\(\\geq 72\\) hours at the time of the index procedure. 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The subject should not receive a \\(P 2 Y _{12}\\) inhibitor in combination with a NOAC but may be treated with a NOAC plus aspirin. \\\\\nc: Holmes, D. R., et al. J Am Coll Cardiol. 2012;59:1200-1254 \\\\\nNishimura, R., et al. J Am Coll Cardiol. 2014;63:2438-88 \\\\\nd: An alternative \\({ P 2 Y _{12}}\\) inhibitor may be prescribed if subject is allergic to or intolerant of clopidogrel.\n\\end{tabular}","text_display":"\\begin{tabular}{l}\naspirin be given indefinitely thereafter as per local standard of care. \\\\\nClopidogrel \\\\\nA loading dose of clopidogrel (recommended dose of \\(\\geq 300 mg\\) ) is required for subjects who have not been taking clopidogrel for \\(\\geq 72\\) hours at the time of the index procedure. The loading dose must be administered prior to the implant procedure. \\\\\nAfter the valve implant procedure, clopidogrel \\({ }^{\\text {d }}\\) (recommended dose of 75 mg daily) is required for at least 1 month. \\\\\nNote: If a subject requires chronic anticoagulation, either clopidogrel or aspirin is required prior to and after the implant procedure in addition to the anticoagulant therapy (but both aspirin and clopidogrel are not required). After the implant procedure, the subject must be treated with warfarin (other anticoagulants are not permitted in the first month) and either clopidogrel (other \\({ P 2 Y _{12}}\\) inhibitors are not permitted in combination with warfarin) or aspirin for at least 1 month. After 1 month, subjects requiring chronic anticoagulation may be switched from warfarin to a new oral anticoagulant (NOAC) at the discretion of the treating physician. The subject should not receive a \\(P 2 Y _{12}\\) inhibitor in combination with a NOAC but may be treated with a NOAC plus aspirin. \\\\\nc: Holmes, D. R., et al. J Am Coll Cardiol. 2012;59:1200-1254 \\\\\nNishimura, R., et al. J Am Coll Cardiol. 2014;63:2438-88 \\\\\nd: An alternative \\({ P 2 Y _{12}}\\) inhibitor may be prescribed if subject is allergic to or intolerant of clopidogrel.\n\\end{tabular}","cell_row":1,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.33275389648913717,"confidence_rate":0.999049406285375},{"cnt":[[602,527],[1737,527],[1737,573],[602,573]],"region":{"top_left_x":602,"top_left_y":526,"width":1136,"height":48},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bb21c6d32d32452e92be9e4c8b64ab6f","type":"text","conversion_output":false,"parent_id":"30a472af5e364216ae5e761ec96374c5","text":"aspirin be given indefinitely thereafter as per local standard of care.","text_display":"aspirin be given indefinitely thereafter as per local standard of care.","confidence":1,"confidence_rate":1},{"cnt":[[602,581],[810,581],[810,630],[602,630]],"region":{"top_left_x":602,"top_left_y":581,"width":208,"height":50},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"76edf091395e47faa44a979a69086064","type":"text","conversion_output":false,"parent_id":"30a472af5e364216ae5e761ec96374c5","text":"Clopidogrel","text_display":"\nClopidogrel","confidence":1,"confidence_rate":1},{"cnt":[[605,641],[1860,641],[1860,690],[605,690]],"region":{"top_left_x":605,"top_left_y":641,"width":1256,"height":50},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6ae17820b74047c1ae32dc175dffe889","type":"text","conversion_output":false,"parent_id":"30a472af5e364216ae5e761ec96374c5","text":"A loading dose of clopidogrel (recommended dose of \\(\\geq 300 mg\\) ) is required","text_display":"\nA loading dose of clopidogrel (recommended dose of \\(\\geq 300 mg\\) ) is required","confidence":0.99951171875,"confidence_rate":0.9999940439141021},{"cnt":[[602,693],[1868,693],[1868,742],[602,742]],"region":{"top_left_x":602,"top_left_y":693,"width":1267,"height":50},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"63bc4d4616794d148550696312748ead","type":"text","conversion_output":false,"parent_id":"30a472af5e364216ae5e761ec96374c5","text":"for subjects who have not been taking clopidogrel for \\(\\geq 72\\) hours at the time","text_display":" for subjects who have not been taking clopidogrel for \\(\\geq 72\\) hours at the time","confidence":1,"confidence_rate":1},{"cnt":[[605,740],[1868,740],[1868,789],[605,789]],"region":{"top_left_x":605,"top_left_y":739,"width":1264,"height":50},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"900163d673f5411e8e0f93db8e8353b0","type":"text","conversion_output":false,"parent_id":"30a472af5e364216ae5e761ec96374c5","text":"of the index procedure. The loading dose must be administered prior to the","text_display":" of the index procedure. The loading dose must be administered prior to the","confidence":1,"confidence_rate":1},{"cnt":[[605,789],[924,789],[924,835],[605,835]],"region":{"top_left_x":605,"top_left_y":788,"width":320,"height":48},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0672a51b9c184d218cc0c97a831fa80e","type":"text","conversion_output":false,"parent_id":"30a472af5e364216ae5e761ec96374c5","text":"implant procedure.","text_display":" implant procedure.","confidence":1,"confidence_rate":1},{"cnt":[[605,838],[1797,838],[1797,895],[605,895]],"region":{"top_left_x":605,"top_left_y":837,"width":1193,"height":59},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"15ee325674164cb1b1702085fde01cff","type":"text","conversion_output":false,"parent_id":"30a472af5e364216ae5e761ec96374c5","text":"After the valve implant procedure, clopidogrel \\({ }^{\\text {d }}\\) (recommended dose of","text_display":"\nAfter the valve implant procedure, clopidogrel \\({ }^{\\text {d }}\\) (recommended dose of","confidence":0.82568359375,"confidence_rate":0.9978501385700251},{"cnt":[[605,898],[1355,898],[1355,944],[605,944]],"region":{"top_left_x":605,"top_left_y":897,"width":751,"height":48},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"20c1ba3a4a164aacab9212f0da18c753","type":"text","conversion_output":false,"parent_id":"30a472af5e364216ae5e761ec96374c5","text":"75 mg daily) is required for at least 1 month.","text_display":" 75 mg daily) is required for at least 1 month.","confidence":1,"confidence_rate":1},{"cnt":[[602,963],[1808,963],[1808,1012],[602,1012]],"region":{"top_left_x":602,"top_left_y":963,"width":1207,"height":50},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"31d0134155e44c388dae13f1defb6dec","type":"text","conversion_output":false,"parent_id":"30a472af5e364216ae5e761ec96374c5","text":"Note: If a subject requires chronic anticoagulation, either clopidogrel or","text_display":"\nNote: If a subject requires chronic anticoagulation, either clopidogrel or","confidence":1,"confidence_rate":1},{"cnt":[[602,1012],[1874,1012],[1874,1059],[602,1059]],"region":{"top_left_x":602,"top_left_y":1012,"width":1272,"height":47},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"59f8519239834810a80342d3bc830d6a","type":"text","conversion_output":false,"parent_id":"30a472af5e364216ae5e761ec96374c5","text":"aspirin is required prior to and after the implant procedure in addition to the","text_display":" aspirin is required prior to and after the implant procedure in addition to the","confidence":1,"confidence_rate":1},{"cnt":[[605,1061],[1825,1061],[1825,1108],[605,1108]],"region":{"top_left_x":605,"top_left_y":1061,"width":1220,"height":47},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6e8ae766253844bea33d292e153ddc20","type":"text","conversion_output":false,"parent_id":"30a472af5e364216ae5e761ec96374c5","text":"anticoagulant therapy (but both aspirin and clopidogrel are not required).","text_display":" anticoagulant therapy (but both aspirin and clopidogrel are not required).","confidence":1,"confidence_rate":1},{"cnt":[[605,1111],[1775,1111],[1775,1157],[605,1157]],"region":{"top_left_x":605,"top_left_y":1110,"width":1171,"height":47},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b4beadd2f01c477489108de86c60c02b","type":"text","conversion_output":false,"parent_id":"30a472af5e364216ae5e761ec96374c5","text":"After the implant procedure, the subject must be treated with warfarin","text_display":" After the implant procedure, the subject must be treated with warfarin","confidence":1,"confidence_rate":1},{"cnt":[[605,1160],[1743,1160],[1743,1203],[605,1203]],"region":{"top_left_x":605,"top_left_y":1159,"width":1138,"height":45},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6d0850ad87e74ab5aee49250382fc9d9","type":"text","conversion_output":false,"parent_id":"30a472af5e364216ae5e761ec96374c5","text":"(other anticoagulants are not permitted in the first month) and either","text_display":" (other anticoagulants are not permitted in the first month) and either","confidence":1,"confidence_rate":1},{"cnt":[[605,1203],[1836,1203],[1836,1252],[605,1252]],"region":{"top_left_x":605,"top_left_y":1203,"width":1231,"height":50},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d6f235f4dcaa4a57b1c4b1cc5eb3a77b","type":"text","conversion_output":false,"parent_id":"30a472af5e364216ae5e761ec96374c5","text":"clopidogrel (other \\({ P 2 Y _{12}}\\) inhibitors are not permitted in combination with","text_display":" clopidogrel (other \\({ P 2 Y _{12}}\\) inhibitors are not permitted in combination with","confidence":0.6323083235364925,"confidence_rate":0.995471885438365},{"cnt":[[605,1252],[1846,1252],[1846,1299],[605,1299]],"region":{"top_left_x":605,"top_left_y":1252,"width":1242,"height":47},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6a9a4365ba524715af24cbfafc9d4cc4","type":"text","conversion_output":false,"parent_id":"30a472af5e364216ae5e761ec96374c5","text":"warfarin) or aspirin for at least 1 month. After 1 month, subjects requiring","text_display":" warfarin) or aspirin for at least 1 month. After 1 month, subjects requiring","confidence":1,"confidence_rate":1},{"cnt":[[605,1302],[1762,1302],[1762,1348],[605,1348]],"region":{"top_left_x":605,"top_left_y":1301,"width":1157,"height":47},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a48ec7f5b6bf44e980bd477df2f9d9ea","type":"text","conversion_output":false,"parent_id":"30a472af5e364216ae5e761ec96374c5","text":"chronic anticoagulation may be switched from warfarin to a new oral","text_display":" chronic anticoagulation may be switched from warfarin to a new oral","confidence":1,"confidence_rate":1},{"cnt":[[605,1348],[1767,1348],[1767,1397],[605,1397]],"region":{"top_left_x":605,"top_left_y":1347,"width":1163,"height":51},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"52dce67e8799411c9146c70f58b085bb","type":"text","conversion_output":false,"parent_id":"30a472af5e364216ae5e761ec96374c5","text":"anticoagulant (NOAC) at the discretion of the treating physician. The","text_display":" anticoagulant (NOAC) at the discretion of the treating physician. The","confidence":1,"confidence_rate":1},{"cnt":[[605,1394],[1846,1394],[1846,1443],[605,1443]],"region":{"top_left_x":605,"top_left_y":1394,"width":1242,"height":50},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"94534fa7adc44682a778795844f3ea12","type":"text","conversion_output":false,"parent_id":"30a472af5e364216ae5e761ec96374c5","text":"subject should not receive a \\(P 2 Y _{12}\\) inhibitor in combination with a NOAC","text_display":" subject should not receive a \\(P 2 Y _{12}\\) inhibitor in combination with a NOAC","confidence":0.6513671875,"confidence_rate":0.9953512546770952},{"cnt":[[605,1443],[1374,1443],[1374,1490],[605,1490]],"region":{"top_left_x":605,"top_left_y":1443,"width":770,"height":47},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9c6deefd3dcc46fb9f704229a854e3d1","type":"text","conversion_output":false,"parent_id":"30a472af5e364216ae5e761ec96374c5","text":"but may be treated with a NOAC plus aspirin.","text_display":" but may be treated with a NOAC plus aspirin.","confidence":1,"confidence_rate":1},{"cnt":[[605,1514],[1666,1514],[1666,1558],[605,1558]],"region":{"top_left_x":605,"top_left_y":1514,"width":1062,"height":45},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d01a15cf584941e8bed2bd3663e42865","type":"text","conversion_output":false,"parent_id":"30a472af5e364216ae5e761ec96374c5","text":"c: Holmes, D. R., et al. J Am Coll Cardiol. 2012;59:1200-1254","text_display":"\nc: Holmes, D. R., et al. J Am Coll Cardiol. 2012;59:1200-1254","confidence":1,"confidence_rate":1},{"cnt":[[651,1569],[1623,1569],[1623,1615],[651,1615]],"region":{"top_left_x":651,"top_left_y":1568,"width":972,"height":48},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c0fcf51e7206409a9d9622f50245b309","type":"text","conversion_output":false,"parent_id":"30a472af5e364216ae5e761ec96374c5","text":"Nishimura, R., et al. J Am Coll Cardiol. 2014;63:2438-88","text_display":"\nNishimura, R., et al. J Am Coll Cardiol. 2014;63:2438-88","confidence":0.99853515625,"confidence_rate":0.9999759688513347},{"cnt":[[605,1629],[1860,1629],[1860,1675],[605,1675]],"region":{"top_left_x":605,"top_left_y":1628,"width":1256,"height":48},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"10b9241722a44807bc1fb3e5557faad4","type":"text","conversion_output":false,"parent_id":"30a472af5e364216ae5e761ec96374c5","text":"d: An alternative \\({ P 2 Y _{12}}\\) inhibitor may be prescribed if subject is allergic to","text_display":"\nd: An alternative \\({ P 2 Y _{12}}\\) inhibitor may be prescribed if subject is allergic to","confidence":0.33275389648913717,"confidence_rate":0.9895751751877736},{"cnt":[[654,1678],[1118,1678],[1118,1724],[654,1724]],"region":{"top_left_x":654,"top_left_y":1678,"width":464,"height":47},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b6a1dd3af8f247f6933b7b5ca448a869","type":"text","conversion_output":false,"parent_id":"30a472af5e364216ae5e761ec96374c5","text":"or intolerant of clopidogrel.","text_display":" or intolerant of clopidogrel.","confidence":0.99951171875,"confidence_rate":0.9999856353826395},{"cnt":[[305,1782],[482,1782],[482,1875],[305,1875]],"region":{"top_left_x":304,"top_left_y":1781,"width":179,"height":94},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d5cb8dc5703241d5b32ef2326a4c8c27","type":"complex_cell","conversion_output":false,"parent_id":"b10d14ac7e904abda79164e66c5da9b9","children_ids":["65f425fe047d47509aa7367f9aedc761","bd98a7eadf95409b8c439eca79e25022"],"text":"Inclusion Criteria","text_display":"Inclusion Criteria","cell_row":2,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[310,1787],[482,1787],[482,1828],[310,1828]],"region":{"top_left_x":310,"top_left_y":1787,"width":173,"height":42},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"65f425fe047d47509aa7367f9aedc761","type":"text","conversion_output":false,"parent_id":"d5cb8dc5703241d5b32ef2326a4c8c27","text":"Inclusion","text_display":"Inclusion","confidence":1,"confidence_rate":1},{"cnt":[[310,1834],[460,1834],[460,1872],[310,1872]],"region":{"top_left_x":310,"top_left_y":1833,"width":151,"height":39},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bd98a7eadf95409b8c439eca79e25022","type":"text","conversion_output":false,"parent_id":"d5cb8dc5703241d5b32ef2326a4c8c27","text":"Criteria","text_display":" Criteria","confidence":1,"confidence_rate":1},{"cnt":[[600,1768],[1876,1768],[1876,2491],[600,2491]],"region":{"top_left_x":599,"top_left_y":1768,"width":1278,"height":724},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"66ea4e7ce0064d0eb26d0c4fa2320aaa","type":"complex_cell","conversion_output":false,"parent_id":"b10d14ac7e904abda79164e66c5da9b9","children_ids":["96b6ff74d15d4a87861eecb53b387cec","26fd1979581541fe9062314507dfe7c1","8b4b311137ab4254946d9a0eebb51ebd","5b3acb05c1064fc489a49072096597a3","96063397aa4a45669027b498f251d651","e779744169a04325bcc3b656f08940fa","89efaa390a6247acad6df3906ce946b5","83c529154de646e09c40dc84a1259c90","c62ce933ec97446eac0a09890c9136d3","960caeb65ddd40008c52dbf012601e01","028cbf42a94f452fba06be3053b8cd66","dfb148076b5d4186ae5f01200ef5dc7d","f9f0fc3dfb154af0b5ddee1bba9a44e2","257b96540fd04a5495648924335c2520"],"text":"\\begin{tabular}{l}\nIC1. Subject has documented calcific, severe native aortic stenosis with an initial AVA of \\(\\leq 1.0 cm^{2}\\) (or AVA index of \\(\\leq 0.6 cm^{2} / m ^{2}\\) ) and a mean pressure gradient \\(\\geq 40 mm Hg\\) or jet velocity \\(\\geq 4.0 m / s\\), as measured by echocardiography and/or invasive hemodynamics. \\\\\nIC2. Subject has a documented aortic annulus size of \\(\\geq 18 mm\\) and \\(\\leq 29 mm\\) based on the center's assessment of pre-procedure diagnostic imaging (and confirmed by the Case Review Committee [CRC]) and, for the randomized cohort, is deemed treatable with an available size of both test and control device. For the U.S. Continued Access Study cohort the acceptable aortic annulus size is \\(\\geq 20 mm\\) and \\(\\leq 27 mm\\). \\\\\nIC3. Subject has symptomatic aortic valve stenosis with NYHA Functional Class \\(\\geq\\) II. \\\\\nIC4. There is agreement by the heart team (which must include a site investigator interventionalist and a site investigator cardiac surgeon)\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nIC1. Subject has documented calcific, severe native aortic stenosis with an initial AVA of \\(\\leq 1.0 cm^{2}\\) (or AVA index of \\(\\leq 0.6 cm^{2} / m ^{2}\\) ) and a mean pressure gradient \\(\\geq 40 mm Hg\\) or jet velocity \\(\\geq 4.0 m / s\\), as measured by echocardiography and/or invasive hemodynamics. \\\\\nIC2. Subject has a documented aortic annulus size of \\(\\geq 18 mm\\) and \\(\\leq 29 mm\\) based on the center's assessment of pre-procedure diagnostic imaging (and confirmed by the Case Review Committee [CRC]) and, for the randomized cohort, is deemed treatable with an available size of both test and control device. For the U.S. Continued Access Study cohort the acceptable aortic annulus size is \\(\\geq 20 mm\\) and \\(\\leq 27 mm\\). \\\\\nIC3. Subject has symptomatic aortic valve stenosis with NYHA Functional Class \\(\\geq\\) II. \\\\\nIC4. There is agreement by the heart team (which must include a site investigator interventionalist and a site investigator cardiac surgeon)\n\\end{tabular}","cell_row":2,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.978515625,"confidence_rate":0.9999806835883139},{"cnt":[[605,1771],[1863,1771],[1863,1820],[605,1820]],"region":{"top_left_x":605,"top_left_y":1770,"width":1258,"height":50},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"96b6ff74d15d4a87861eecb53b387cec","type":"text","conversion_output":false,"parent_id":"66ea4e7ce0064d0eb26d0c4fa2320aaa","text":"IC1. Subject has documented calcific, severe native aortic stenosis with an","text_display":"IC1. Subject has documented calcific, severe native aortic stenosis with an","confidence":1,"confidence_rate":1},{"cnt":[[698,1814],[1855,1814],[1855,1872],[698,1872]],"region":{"top_left_x":697,"top_left_y":1814,"width":1158,"height":58},"line":48,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"26fd1979581541fe9062314507dfe7c1","type":"text","conversion_output":false,"parent_id":"66ea4e7ce0064d0eb26d0c4fa2320aaa","text":"initial AVA of \\(\\leq 1.0 cm^{2}\\) (or AVA index of \\(\\leq 0.6 cm^{2} / m ^{2}\\) ) and a mean","text_display":" initial AVA of \\(\\leq 1.0 cm^{2}\\) (or AVA index of \\(\\leq 0.6 cm^{2} / m ^{2}\\) ) and a mean","confidence":0.99951171875,"confidence_rate":0.9999953038523912},{"cnt":[[698,1869],[1830,1869],[1830,1918],[698,1918]],"region":{"top_left_x":697,"top_left_y":1869,"width":1134,"height":50},"line":49,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8b4b311137ab4254946d9a0eebb51ebd","type":"text","conversion_output":false,"parent_id":"66ea4e7ce0064d0eb26d0c4fa2320aaa","text":"pressure gradient \\(\\geq 40 mm Hg\\) or jet velocity \\(\\geq 4.0 m / s\\), as measured","text_display":" pressure gradient \\(\\geq 40 mm Hg\\) or jet velocity \\(\\geq 4.0 m / s\\), as measured","confidence":0.978515625,"confidence_rate":0.9997414795655649},{"cnt":[[698,1918],[1595,1918],[1595,1965],[698,1965]],"region":{"top_left_x":697,"top_left_y":1918,"width":899,"height":47},"line":50,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5b3acb05c1064fc489a49072096597a3","type":"text","conversion_output":false,"parent_id":"66ea4e7ce0064d0eb26d0c4fa2320aaa","text":"by echocardiography and/or invasive hemodynamics.","text_display":" by echocardiography and/or invasive hemodynamics.","confidence":1,"confidence_rate":1},{"cnt":[[605,1973],[1874,1973],[1874,2025],[605,2025]],"region":{"top_left_x":605,"top_left_y":1972,"width":1269,"height":53},"line":51,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"96063397aa4a45669027b498f251d651","type":"text","conversion_output":false,"parent_id":"66ea4e7ce0064d0eb26d0c4fa2320aaa","text":"IC2. Subject has a documented aortic annulus size of \\(\\geq 18 mm\\) and \\(\\leq 29 mm\\)","text_display":"\nIC2. 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For the U.S. Continued Access Study cohort","text_display":" test and control device. 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Predicted operative mortality or serious,","confidence":1,"confidence_rate":1},{"cnt":[[701,854],[1443,854],[1443,900],[701,900]],"region":{"top_left_x":700,"top_left_y":854,"width":743,"height":47},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3c40a31c8d0b40999f8260a8093d7dcf","type":"text","conversion_output":false,"parent_id":"8743a9503930444eb34c90fb69d601b5","text":"irreversible morbidity risk \\(\\geq 15 \\%\\) at 30 days.","text_display":" irreversible morbidity risk \\(\\geq 15 \\%\\) at 30 days.","confidence":1,"confidence_rate":1},{"cnt":[[698,914],[1863,914],[1863,961],[698,961]],"region":{"top_left_x":697,"top_left_y":914,"width":1166,"height":47},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9c3a9bbfac2744fa9b52962c37fbbbe9","type":"text","conversion_output":false,"parent_id":"8743a9503930444eb34c90fb69d601b5","text":"Risk of operative mortality and morbidity must be assessed via an in-","text_display":"\nRisk of operative mortality and morbidity must be assessed via an in","confidence":1,"confidence_rate":1},{"cnt":[[698,963],[1863,963],[1863,1010],[698,1010]],"region":{"top_left_x":697,"top_left_y":963,"width":1166,"height":47},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2ab97e11c5d24316993e6d38f4d8e608","type":"text","conversion_output":false,"parent_id":"8743a9503930444eb34c90fb69d601b5","text":"person evaluation by a center cardiac surgeon and must be confirmed","text_display":"person evaluation by a center cardiac surgeon and must be confirmed","confidence":1,"confidence_rate":1},{"cnt":[[698,1010],[1811,1010],[1811,1059],[698,1059]],"region":{"top_left_x":697,"top_left_y":1009,"width":1114,"height":50},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"12353ed1dff24e219c94af43367b24ee","type":"text","conversion_output":false,"parent_id":"8743a9503930444eb34c90fb69d601b5","text":"by the CRC (which must include an experienced cardiac surgeon).","text_display":" by the CRC (which must include an experienced cardiac surgeon).","confidence":1,"confidence_rate":1},{"cnt":[[305,1100],[493,1100],[493,1198],[305,1198]],"region":{"top_left_x":304,"top_left_y":1099,"width":190,"height":99},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"615464df67c8426bbf903f85edbdd509","type":"complex_cell","conversion_output":false,"parent_id":"b2cfe101eada4675b9903ed4f93607ee","children_ids":["830b9471a37844558be4da3563a99824","6d9caaa3b39f483c8f2b10d6b69b13ed"],"text":"Exclusion Criteria","text_display":"Exclusion Criteria","cell_row":2,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[310,1105],[493,1105],[493,1146],[310,1146]],"region":{"top_left_x":310,"top_left_y":1105,"width":184,"height":42},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"830b9471a37844558be4da3563a99824","type":"text","conversion_output":false,"parent_id":"615464df67c8426bbf903f85edbdd509","text":"Exclusion","text_display":"Exclusion","confidence":1,"confidence_rate":1},{"cnt":[[310,1154],[460,1154],[460,1195],[310,1195]],"region":{"top_left_x":310,"top_left_y":1154,"width":151,"height":42},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6d9caaa3b39f483c8f2b10d6b69b13ed","type":"text","conversion_output":false,"parent_id":"615464df67c8426bbf903f85edbdd509","text":"Criteria","text_display":" Criteria","confidence":1,"confidence_rate":1},{"cnt":[[600,1100],[1876,1100],[1876,2472],[600,2472]],"region":{"top_left_x":599,"top_left_y":1099,"width":1278,"height":1374},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"089931aa50324691b7bedc184236e87b","type":"complex_cell","conversion_output":false,"parent_id":"b2cfe101eada4675b9903ed4f93607ee","children_ids":["501b07a504524297b141491b5cf2928d","f033768c806b46c390e32cbf54061e64","fa3fb93fe6a24480b855b88e5947c622","00cdafbf8199499a88cccdb465e7e4f6","59e6b55f363c476b958cd3b188f1d3ab","824546efbd97401fbecb830d61e46186","749286fb00a943b6bf477cd67fd093d9","e6c25705feb94c1abf07127379f084bf","3842075e9ba34d699a6aa541865a86dc","b28bdc12ed334bf2805ef9a42749f5d5","3a5793fe6cbc4a989f1773b41fd24dac","74185c1831d24d6e9584eb3b6f33765f","cfd9e062435343db99cc2663c1d72bc8","9cc0be5561354ffc992436f1f9811b10","5ef79d951f0e4ea1b4fa0a6e4c566204","4c24d59b40184e2aa2d4fd09829b6e94","98019277178a4f8b811d99843acc3b67","6d5b5e4619a743a599a0c8b4791cdd09","d86b9db427134c0e8c9d7e31730552ed","d144f1ba18014af0a2ebbaf90f5e11f4","72dd139d763f45a68b0ae16f4c37e383","0ded96054ea44ce4933e9cd2cfc85ff8","13c7eabde59e425faf1a111148ad6f7d","81488535f01740f38adc2e6ad8f229a2","fbdf6660eabe4642af13d3f510b655b4","2887edc3cac141fb87d976e03b07164a"],"text":"\\begin{tabular}{l}\nEC1. Subject has a congenital unicuspid or bicuspid aortic valve. \\\\\nEC2. Subject has had an acute myocardial infarction within 30 days prior to the index procedure (defined as Q-wave MI or non-Q-wave MI with total CK elevation \\(\\geq\\) twice normal in the presence of CK-MB elevation and/or troponin elevation). \\\\\nEC3. Subject has had a cerebrovascular accident or transient ischemic attack within the past 6 months prior to study enrollment. \\\\\nEC4. Subject has end-stage renal disease or has GFR \\(<20\\) (based on Cockcroft-Gault formula). \\\\\nEC5. Subject has a pre-existing prosthetic aortic or mitral valve. \\\\\nEC6. Subject has severe ( \\(4+\\) ) aortic, tricuspid, or mitral regurgitation. \\\\\nEC7. Subject has a need for emergency surgery for any reason. \\\\\nEC8. Subject has a history of endocarditis within 6 months of index procedure or evidence of an active systemic infection or sepsis. \\\\\nEC9. Subject has echocardiographic evidence of new intra-cardiac vegetation or intraventricular or paravalvular thrombus requiring intervention. \\\\\nEC10. Subject has \\(Hgb <9 g / dL\\), platelet count \\(<50,000\\) cells \\(/ mm ^{3}\\) or \\(>700,000\\) cells \\(/ mm ^{3}\\), or white blood cell count \\(<1,000\\) cells \\(/ mm ^{3}\\). \\\\\nEC11. Subject requires chronic anticoagulation therapy after the implant procedure and cannot be treated with warfarin (other anticoagulants are not permitted in the first month) for at least 1 month concomitant with either aspirin or clopidogrel. \\\\\nEC12. Subject has had a gastrointestinal bleed requiring hospitalization or transfusion within the past 3 months, or has other clinically significant bleeding diathesis or coagulopathy that would preclude\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nEC1. Subject has a congenital unicuspid or bicuspid aortic valve. \\\\\nEC2. Subject has had an acute myocardial infarction within 30 days prior to the index procedure (defined as Q-wave MI or non-Q-wave MI with total CK elevation \\(\\geq\\) twice normal in the presence of CK-MB elevation and/or troponin elevation). \\\\\nEC3. Subject has had a cerebrovascular accident or transient ischemic attack within the past 6 months prior to study enrollment. \\\\\nEC4. Subject has end-stage renal disease or has GFR \\(<20\\) (based on Cockcroft-Gault formula). \\\\\nEC5. Subject has a pre-existing prosthetic aortic or mitral valve. \\\\\nEC6. Subject has severe ( \\(4+\\) ) aortic, tricuspid, or mitral regurgitation. \\\\\nEC7. Subject has a need for emergency surgery for any reason. \\\\\nEC8. Subject has a history of endocarditis within 6 months of index procedure or evidence of an active systemic infection or sepsis. \\\\\nEC9. Subject has echocardiographic evidence of new intra-cardiac vegetation or intraventricular or paravalvular thrombus requiring intervention. \\\\\nEC10. Subject has \\(Hgb <9 g / dL\\), platelet count \\(<50,000\\) cells \\(/ mm ^{3}\\) or \\(>700,000\\) cells \\(/ mm ^{3}\\), or white blood cell count \\(<1,000\\) cells \\(/ mm ^{3}\\). \\\\\nEC11. Subject requires chronic anticoagulation therapy after the implant procedure and cannot be treated with warfarin (other anticoagulants are not permitted in the first month) for at least 1 month concomitant with either aspirin or clopidogrel. \\\\\nEC12. Subject has had a gastrointestinal bleed requiring hospitalization or transfusion within the past 3 months, or has other clinically significant bleeding diathesis or coagulopathy that would preclude\n\\end{tabular}","cell_row":2,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.5726099014282227,"confidence_rate":0.9997056384282345},{"cnt":[[602,1102],[1710,1102],[1710,1151],[602,1151]],"region":{"top_left_x":602,"top_left_y":1102,"width":1109,"height":50},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"501b07a504524297b141491b5cf2928d","type":"text","conversion_output":false,"parent_id":"089931aa50324691b7bedc184236e87b","text":"EC1. Subject has a congenital unicuspid or bicuspid aortic valve.","text_display":"EC1. Subject has a congenital unicuspid or bicuspid aortic valve.","confidence":0.99951171875,"confidence_rate":0.9999930228743673},{"cnt":[[602,1160],[1852,1160],[1852,1212],[602,1212]],"region":{"top_left_x":602,"top_left_y":1159,"width":1250,"height":53},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f033768c806b46c390e32cbf54061e64","type":"text","conversion_output":false,"parent_id":"089931aa50324691b7bedc184236e87b","text":"EC2. Subject has had an acute myocardial infarction within 30 days prior","text_display":"\nEC2. Subject has had an acute myocardial infarction within 30 days prior","confidence":1,"confidence_rate":1},{"cnt":[[714,1209],[1827,1209],[1827,1261],[714,1261]],"region":{"top_left_x":714,"top_left_y":1208,"width":1114,"height":53},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fa3fb93fe6a24480b855b88e5947c622","type":"text","conversion_output":false,"parent_id":"089931aa50324691b7bedc184236e87b","text":"to the index procedure (defined as Q-wave MI or non-Q-wave MI","text_display":" to the index procedure (defined as Q-wave MI or non-Q-wave MI","confidence":0.98681640625,"confidence_rate":0.9997989403855609},{"cnt":[[714,1258],[1825,1258],[1825,1304],[714,1304]],"region":{"top_left_x":714,"top_left_y":1257,"width":1111,"height":48},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"00cdafbf8199499a88cccdb465e7e4f6","type":"text","conversion_output":false,"parent_id":"089931aa50324691b7bedc184236e87b","text":"with total CK elevation \\(\\geq\\) twice normal in the presence of CK-MB","text_display":" with total CK elevation \\(\\geq\\) twice normal in the presence of CK-MB","confidence":0.9980480668600649,"confidence_rate":0.9999724814963304},{"cnt":[[714,1307],[1328,1307],[1328,1353],[714,1353]],"region":{"top_left_x":714,"top_left_y":1307,"width":615,"height":47},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"59e6b55f363c476b958cd3b188f1d3ab","type":"text","conversion_output":false,"parent_id":"089931aa50324691b7bedc184236e87b","text":"elevation and/or troponin elevation).","text_display":" elevation and/or troponin elevation).","confidence":1,"confidence_rate":1},{"cnt":[[602,1362],[1795,1362],[1795,1413],[602,1413]],"region":{"top_left_x":602,"top_left_y":1361,"width":1193,"height":53},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"824546efbd97401fbecb830d61e46186","type":"text","conversion_output":false,"parent_id":"089931aa50324691b7bedc184236e87b","text":"EC3. Subject has had a cerebrovascular accident or transient ischemic","text_display":"\nEC3. Subject has had a cerebrovascular accident or transient ischemic","confidence":1,"confidence_rate":1},{"cnt":[[714,1411],[1677,1411],[1677,1463],[714,1463]],"region":{"top_left_x":714,"top_left_y":1410,"width":964,"height":53},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"749286fb00a943b6bf477cd67fd093d9","type":"text","conversion_output":false,"parent_id":"089931aa50324691b7bedc184236e87b","text":"attack within the past 6 months prior to study enrollment.","text_display":" attack within the past 6 months prior to study enrollment.","confidence":1,"confidence_rate":1},{"cnt":[[602,1471],[1759,1471],[1759,1523],[602,1523]],"region":{"top_left_x":602,"top_left_y":1470,"width":1158,"height":53},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e6c25705feb94c1abf07127379f084bf","type":"text","conversion_output":false,"parent_id":"089931aa50324691b7bedc184236e87b","text":"EC4. Subject has end-stage renal disease or has GFR \\(<20\\) (based on","text_display":"\nEC4. Subject has end-stage renal disease or has GFR \\(<20\\) (based on","confidence":0.9583771449979395,"confidence_rate":0.9994177873742666},{"cnt":[[714,1520],[1162,1520],[1162,1566],[714,1566]],"region":{"top_left_x":714,"top_left_y":1519,"width":448,"height":48},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3842075e9ba34d699a6aa541865a86dc","type":"text","conversion_output":false,"parent_id":"089931aa50324691b7bedc184236e87b","text":"Cockcroft-Gault formula).","text_display":" Cockcroft-Gault formula).","confidence":1,"confidence_rate":1},{"cnt":[[605,1577],[1694,1577],[1694,1626],[605,1626]],"region":{"top_left_x":605,"top_left_y":1577,"width":1089,"height":50},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b28bdc12ed334bf2805ef9a42749f5d5","type":"text","conversion_output":false,"parent_id":"089931aa50324691b7bedc184236e87b","text":"EC5. Subject has a pre-existing prosthetic aortic or mitral valve.","text_display":"\nEC5. Subject has a pre-existing prosthetic aortic or mitral valve.","confidence":0.99951171875,"confidence_rate":0.9999931211434043},{"cnt":[[605,1634],[1786,1634],[1786,1686],[605,1686]],"region":{"top_left_x":605,"top_left_y":1634,"width":1182,"height":53},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3a5793fe6cbc4a989f1773b41fd24dac","type":"text","conversion_output":false,"parent_id":"089931aa50324691b7bedc184236e87b","text":"EC6. Subject has severe ( \\(4+\\) ) aortic, tricuspid, or mitral regurgitation.","text_display":"\nEC6. Subject has severe ( \\(4+\\) ) aortic, tricuspid, or mitral regurgitation.","confidence":0.5726099014282227,"confidence_rate":0.9932236661077756},{"cnt":[[602,1694],[1677,1694],[1677,1744],[602,1744]],"region":{"top_left_x":602,"top_left_y":1694,"width":1076,"height":50},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"74185c1831d24d6e9584eb3b6f33765f","type":"text","conversion_output":false,"parent_id":"089931aa50324691b7bedc184236e87b","text":"EC7. Subject has a need for emergency surgery for any reason.","text_display":"\nEC7. Subject has a need for emergency surgery for any reason.","confidence":0.99951171875,"confidence_rate":0.9999926000198329},{"cnt":[[602,1749],[1759,1749],[1759,1801],[602,1801]],"region":{"top_left_x":602,"top_left_y":1748,"width":1158,"height":53},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cfd9e062435343db99cc2663c1d72bc8","type":"text","conversion_output":false,"parent_id":"089931aa50324691b7bedc184236e87b","text":"EC8. Subject has a history of endocarditis within 6 months of index","text_display":"\nEC8. Subject has a history of endocarditis within 6 months of index","confidence":0.9990236759185791,"confidence_rate":0.9999869760715292},{"cnt":[[714,1798],[1775,1798],[1775,1850],[714,1850]],"region":{"top_left_x":714,"top_left_y":1798,"width":1062,"height":52},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9cc0be5561354ffc992436f1f9811b10","type":"text","conversion_output":false,"parent_id":"089931aa50324691b7bedc184236e87b","text":"procedure or evidence of an active systemic infection or sepsis.","text_display":" procedure or evidence of an active systemic infection or sepsis.","confidence":1,"confidence_rate":1},{"cnt":[[602,1858],[1737,1858],[1737,1907],[602,1907]],"region":{"top_left_x":602,"top_left_y":1858,"width":1136,"height":50},"line":48,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5ef79d951f0e4ea1b4fa0a6e4c566204","type":"text","conversion_output":false,"parent_id":"089931aa50324691b7bedc184236e87b","text":"EC9. Subject has echocardiographic evidence of new intra-cardiac","text_display":"\nEC9. Subject has echocardiographic evidence of new intra-cardiac","confidence":1,"confidence_rate":1},{"cnt":[[714,1907],[1806,1907],[1806,1959],[714,1959]],"region":{"top_left_x":714,"top_left_y":1907,"width":1092,"height":53},"line":49,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4c24d59b40184e2aa2d4fd09829b6e94","type":"text","conversion_output":false,"parent_id":"089931aa50324691b7bedc184236e87b","text":"vegetation or intraventricular or paravalvular thrombus requiring","text_display":" vegetation or intraventricular or paravalvular thrombus requiring","confidence":1,"confidence_rate":1},{"cnt":[[714,1956],[935,1956],[935,1997],[714,1997]],"region":{"top_left_x":714,"top_left_y":1956,"width":222,"height":42},"line":50,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"98019277178a4f8b811d99843acc3b67","type":"text","conversion_output":false,"parent_id":"089931aa50324691b7bedc184236e87b","text":"intervention.","text_display":" intervention.","confidence":1,"confidence_rate":1},{"cnt":[[602,2005],[1759,2005],[1759,2060],[602,2060]],"region":{"top_left_x":602,"top_left_y":2005,"width":1158,"height":56},"line":51,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6d5b5e4619a743a599a0c8b4791cdd09","type":"text","conversion_output":false,"parent_id":"089931aa50324691b7bedc184236e87b","text":"EC10. Subject has \\(Hgb <9 g / dL\\), platelet count \\(<50,000\\) cells \\(/ mm ^{3}\\) or","text_display":"\nEC10. Subject has \\(Hgb <9 g / dL\\), platelet count \\(<50,000\\) cells \\(/ mm ^{3}\\) or","confidence":0.9990234375,"confidence_rate":0.9999901309613475},{"cnt":[[711,2055],[1808,2055],[1808,2106],[711,2106]],"region":{"top_left_x":711,"top_left_y":2054,"width":1098,"height":53},"line":52,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d86b9db427134c0e8c9d7e31730552ed","type":"text","conversion_output":false,"parent_id":"089931aa50324691b7bedc184236e87b","text":"\\(>700,000\\) cells \\(/ mm ^{3}\\), or white blood cell count \\(<1,000\\) cells \\(/ mm ^{3}\\).","text_display":" \\(>700,000\\) cells \\(/ mm ^{3}\\), or white blood cell count \\(<1,000\\) cells \\(/ mm ^{3}\\).","confidence":1,"confidence_rate":1},{"cnt":[[602,2120],[1819,2120],[1819,2166],[602,2166]],"region":{"top_left_x":602,"top_left_y":2120,"width":1218,"height":47},"line":53,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d144f1ba18014af0a2ebbaf90f5e11f4","type":"text","conversion_output":false,"parent_id":"089931aa50324691b7bedc184236e87b","text":"EC11. Subject requires chronic anticoagulation therapy after the implant","text_display":"\nEC11. Subject requires chronic anticoagulation therapy after the implant","confidence":1,"confidence_rate":1},{"cnt":[[714,2169],[1852,2169],[1852,2216],[714,2216]],"region":{"top_left_x":714,"top_left_y":2169,"width":1138,"height":47},"line":54,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"72dd139d763f45a68b0ae16f4c37e383","type":"text","conversion_output":false,"parent_id":"089931aa50324691b7bedc184236e87b","text":"procedure and cannot be treated with warfarin (other anticoagulants","text_display":" procedure and cannot be treated with warfarin (other anticoagulants","confidence":1,"confidence_rate":1},{"cnt":[[714,2213],[1874,2213],[1874,2265],[714,2265]],"region":{"top_left_x":714,"top_left_y":2212,"width":1160,"height":53},"line":55,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0ded96054ea44ce4933e9cd2cfc85ff8","type":"text","conversion_output":false,"parent_id":"089931aa50324691b7bedc184236e87b","text":"are not permitted in the first month) for at least 1 month concomitant","text_display":" are not permitted in the first month) for at least 1 month concomitant","confidence":1,"confidence_rate":1},{"cnt":[[714,2262],[1279,2262],[1279,2314],[714,2314]],"region":{"top_left_x":714,"top_left_y":2261,"width":565,"height":53},"line":56,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"13c7eabde59e425faf1a111148ad6f7d","type":"text","conversion_output":false,"parent_id":"089931aa50324691b7bedc184236e87b","text":"with either aspirin or clopidogrel.","text_display":" with either aspirin or clopidogrel.","confidence":1,"confidence_rate":1},{"cnt":[[605,2322],[1846,2322],[1846,2368],[605,2368]],"region":{"top_left_x":605,"top_left_y":2321,"width":1242,"height":48},"line":57,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"81488535f01740f38adc2e6ad8f229a2","type":"text","conversion_output":false,"parent_id":"089931aa50324691b7bedc184236e87b","text":"EC12. Subject has had a gastrointestinal bleed requiring hospitalization or","text_display":"\nEC12. 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Subject has known hypersensitivity to contrast agents that cannot be","text_display":"\nEC13. Subject has known hypersensitivity to contrast agents that cannot be","confidence":1,"confidence_rate":1},{"cnt":[[714,679],[1852,679],[1852,726],[714,726]],"region":{"top_left_x":714,"top_left_y":679,"width":1138,"height":47},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3b8f02021eef46c49b903372f67e9655","type":"text","conversion_output":false,"parent_id":"eea5059eabcf4d32a9810d11043c468e","text":"adequately pre-medicated, or has known hypersensitivity to aspirin,","text_display":" adequately pre-medicated, or has known hypersensitivity to aspirin,","confidence":1,"confidence_rate":1},{"cnt":[[714,729],[1699,729],[1699,775],[714,775]],"region":{"top_left_x":714,"top_left_y":728,"width":986,"height":47},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9d56436a09cd4018ac6c73733d28f1b5","type":"text","conversion_output":false,"parent_id":"eea5059eabcf4d32a9810d11043c468e","text":"all \\(P 2 Y _{12}\\) inhibitors, heparin, nickel, tantalum, titanium, or","text_display":" all \\(P 2 Y _{12}\\) inhibitors, heparin, nickel, tantalum, titanium, or","confidence":0.5702126026153564,"confidence_rate":0.9931728506179669},{"cnt":[[714,778],[965,778],[965,824],[714,824]],"region":{"top_left_x":714,"top_left_y":777,"width":252,"height":48},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bdaae8086d874916bf20ce6ae63cb977","type":"text","conversion_output":false,"parent_id":"eea5059eabcf4d32a9810d11043c468e","text":"polyurethanes.","text_display":" polyurethanes.","confidence":1,"confidence_rate":1},{"cnt":[[602,832],[1792,832],[1792,879],[602,879]],"region":{"top_left_x":602,"top_left_y":832,"width":1190,"height":47},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a870b8b38c1b4486a60eb216fefd65df","type":"text","conversion_output":false,"parent_id":"eea5059eabcf4d32a9810d11043c468e","text":"EC14. Subject has a life expectancy of less than 12 months due to non-","text_display":"\nEC14. Subject has a life expectancy of less than 12 months due to non","confidence":1,"confidence_rate":1},{"cnt":[[714,881],[1726,881],[1726,928],[714,928]],"region":{"top_left_x":714,"top_left_y":881,"width":1013,"height":47},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"24bcc074185d425b846b82f1ce8ebaa5","type":"text","conversion_output":false,"parent_id":"eea5059eabcf4d32a9810d11043c468e","text":"cardiac, comorbid conditions based on the assessment of the","text_display":"cardiac, comorbid conditions based on the assessment of the","confidence":1,"confidence_rate":1},{"cnt":[[714,930],[1350,930],[1350,977],[714,977]],"region":{"top_left_x":714,"top_left_y":930,"width":636,"height":47},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9f3de6344b0b4e3cb172e045df81d398","type":"text","conversion_output":false,"parent_id":"eea5059eabcf4d32a9810d11043c468e","text":"investigator at the time of enrollment.","text_display":" investigator at the time of enrollment.","confidence":1,"confidence_rate":1},{"cnt":[[605,988],[1623,988],[1623,1037],[605,1037]],"region":{"top_left_x":605,"top_left_y":987,"width":1018,"height":50},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"17d727ab71e3463b8a3a27da883c4072","type":"text","conversion_output":false,"parent_id":"eea5059eabcf4d32a9810d11043c468e","text":"EC15. Subject has hypertrophic obstructive cardiomyopathy.","text_display":"\nEC15. Subject has hypertrophic obstructive cardiomyopathy.","confidence":1,"confidence_rate":1},{"cnt":[[605,1045],[1830,1045],[1830,1091],[605,1091]],"region":{"top_left_x":605,"top_left_y":1045,"width":1226,"height":47},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fb47d7af49bb49aba2cda8fb6add1571","type":"text","conversion_output":false,"parent_id":"eea5059eabcf4d32a9810d11043c468e","text":"EC16. Subject has any therapeutic invasive cardiac or vascular procedure","text_display":"\nEC16. Subject has any therapeutic invasive cardiac or vascular procedure","confidence":1,"confidence_rate":1},{"cnt":[[714,1094],[1874,1094],[1874,1141],[714,1141]],"region":{"top_left_x":714,"top_left_y":1094,"width":1160,"height":47},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"05f577eb51214cca87719c8ac8e83654","type":"text","conversion_output":false,"parent_id":"eea5059eabcf4d32a9810d11043c468e","text":"within 30 days prior to the index procedure (except for balloon aortic","text_display":" within 30 days prior to the index procedure (except for balloon aortic","confidence":1,"confidence_rate":1},{"cnt":[[714,1143],[1751,1143],[1751,1190],[714,1190]],"region":{"top_left_x":714,"top_left_y":1143,"width":1037,"height":47},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f6e4cbc5d78f48e698fa330b7095d565","type":"text","conversion_output":false,"parent_id":"eea5059eabcf4d32a9810d11043c468e","text":"valvuloplasty or pacemaker implantation, which are allowed).","text_display":" valvuloplasty or pacemaker implantation, which are allowed).","confidence":1,"confidence_rate":1},{"cnt":[[605,1198],[1838,1198],[1838,1247],[605,1247]],"region":{"top_left_x":605,"top_left_y":1197,"width":1234,"height":50},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"585be2a9f89b4a2a88e357f094903901","type":"text","conversion_output":false,"parent_id":"eea5059eabcf4d32a9810d11043c468e","text":"EC17. Subject has untreated coronary artery disease, which in the opinion","text_display":"\nEC17. Subject has untreated coronary artery disease, which in the opinion","confidence":1,"confidence_rate":1},{"cnt":[[714,1247],[1732,1247],[1732,1293],[714,1293]],"region":{"top_left_x":714,"top_left_y":1246,"width":1018,"height":48},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bdec836e73bd4ab0bd2fb66f6b23c228","type":"text","conversion_output":false,"parent_id":"eea5059eabcf4d32a9810d11043c468e","text":"of the treating physician is clinically significant and requires","text_display":" of the treating physician is clinically significant and requires","confidence":1,"confidence_rate":1},{"cnt":[[714,1296],[1017,1296],[1017,1337],[714,1337]],"region":{"top_left_x":714,"top_left_y":1296,"width":304,"height":42},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a676f5bfa35c4347845d5e12c48cae5c","type":"text","conversion_output":false,"parent_id":"eea5059eabcf4d32a9810d11043c468e","text":"revascularization.","text_display":" revascularization.","confidence":1,"confidence_rate":1},{"cnt":[[605,1353],[1860,1353],[1860,1402],[605,1402]],"region":{"top_left_x":605,"top_left_y":1353,"width":1256,"height":50},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"149052531c9c497b990f7857ab335b8e","type":"text","conversion_output":false,"parent_id":"eea5059eabcf4d32a9810d11043c468e","text":"EC18. Subject has severe left ventricular dysfunction with ejection fraction","text_display":"\nEC18. Subject has severe left ventricular dysfunction with ejection fraction","confidence":1,"confidence_rate":1},{"cnt":[[714,1405],[834,1405],[834,1446],[714,1446]],"region":{"top_left_x":714,"top_left_y":1405,"width":121,"height":42},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7282bba8649548ac98f61be44315dbe9","type":"text","conversion_output":false,"parent_id":"eea5059eabcf4d32a9810d11043c468e","text":"<20\\%.","text_display":" <20\\%.","confidence":0.97119140625,"confidence_rate":0.9970810975730111},{"cnt":[[605,1460],[1775,1460],[1775,1506],[605,1506]],"region":{"top_left_x":605,"top_left_y":1459,"width":1171,"height":48},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e9ce8907914843b098704d1cabfaa68e","type":"text","conversion_output":false,"parent_id":"eea5059eabcf4d32a9810d11043c468e","text":"EC19. Subject is in cardiogenic shock or has hemodynamic instability","text_display":"\nEC19. Subject is in cardiogenic shock or has hemodynamic instability","confidence":1,"confidence_rate":1},{"cnt":[[714,1509],[1694,1509],[1694,1555],[714,1555]],"region":{"top_left_x":714,"top_left_y":1508,"width":980,"height":48},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"807c0f4c7a76477eb0c74a5a890974c4","type":"text","conversion_output":false,"parent_id":"eea5059eabcf4d32a9810d11043c468e","text":"requiring inotropic support or mechanical support devices.","text_display":" requiring inotropic support or mechanical support devices.","confidence":1,"confidence_rate":1},{"cnt":[[605,1569],[1846,1569],[1846,1615],[605,1615]],"region":{"top_left_x":605,"top_left_y":1568,"width":1242,"height":48},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7338c4adfac8447cb85ced21d775fd23","type":"text","conversion_output":false,"parent_id":"eea5059eabcf4d32a9810d11043c468e","text":"EC20. Subject has severe vascular disease that would preclude safe access","text_display":"\nEC20. Subject has severe vascular disease that would preclude safe access","confidence":1,"confidence_rate":1},{"cnt":[[714,1618],[1868,1618],[1868,1664],[714,1664]],"region":{"top_left_x":714,"top_left_y":1618,"width":1155,"height":47},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"674c8aff47c7457fb4df0f8dbeabbbf5","type":"text","conversion_output":false,"parent_id":"eea5059eabcf4d32a9810d11043c468e","text":"(e.g., aneurysm with thrombus that cannot be crossed safely, marked","text_display":" (e.g., aneurysm with thrombus that cannot be crossed safely, marked","confidence":1,"confidence_rate":1},{"cnt":[[714,1664],[1773,1664],[1773,1708],[714,1708]],"region":{"top_left_x":714,"top_left_y":1664,"width":1059,"height":45},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e64b24fc7a1344a29368a1f60e8ee7bd","type":"text","conversion_output":false,"parent_id":"eea5059eabcf4d32a9810d11043c468e","text":"tortuosity, significant narrowing of the abdominal aorta, severe","text_display":" tortuosity, significant narrowing of the abdominal aorta, severe","confidence":1,"confidence_rate":1},{"cnt":[[714,1711],[1838,1711],[1838,1757],[714,1757]],"region":{"top_left_x":714,"top_left_y":1710,"width":1125,"height":48},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ed2151c16b5a4c7dbaa23b491233f9a6","type":"text","conversion_output":false,"parent_id":"eea5059eabcf4d32a9810d11043c468e","text":"unfolding of the thoracic aorta, or symptomatic carotid or vertebral","text_display":" unfolding of the thoracic aorta, or symptomatic carotid or vertebral","confidence":1,"confidence_rate":1},{"cnt":[[714,1760],[864,1760],[864,1806],[714,1806]],"region":{"top_left_x":714,"top_left_y":1759,"width":151,"height":48},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bb7368a526774109910a3f8e47c97342","type":"text","conversion_output":false,"parent_id":"eea5059eabcf4d32a9810d11043c468e","text":"disease).","text_display":" disease).","confidence":1,"confidence_rate":1},{"cnt":[[605,1814],[1830,1814],[1830,1866],[605,1866]],"region":{"top_left_x":605,"top_left_y":1814,"width":1226,"height":53},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e6aa719f94134d68be62afef4992eb02","type":"text","conversion_output":false,"parent_id":"eea5059eabcf4d32a9810d11043c468e","text":"EC21. Subject has thick (>5 mm) protruding or ulcerated atheroma in the","text_display":"\nEC21. Subject has thick (>5 mm) protruding or ulcerated atheroma in the","confidence":0.6059642741456628,"confidence_rate":0.9934304344681875},{"cnt":[[714,1864],[900,1864],[900,1905],[714,1905]],"region":{"top_left_x":714,"top_left_y":1863,"width":186,"height":42},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"35e4fe507c6a418f9a61ee1dcc4945c4","type":"text","conversion_output":false,"parent_id":"eea5059eabcf4d32a9810d11043c468e","text":"aortic arch","text_display":" aortic arch","confidence":1,"confidence_rate":1},{"cnt":[[602,1924],[1781,1924],[1781,1970],[602,1970]],"region":{"top_left_x":602,"top_left_y":1923,"width":1179,"height":47},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a0971fccdf7546ca8ddd5b4afa0b0319","type":"text","conversion_output":false,"parent_id":"eea5059eabcf4d32a9810d11043c468e","text":"EC22. Subject has arterial access that is not acceptable for the test and","text_display":"\nEC22. Subject has arterial access that is not acceptable for the test and","confidence":0.99951171875,"confidence_rate":0.9999937384747559},{"cnt":[[714,1973],[1857,1973],[1857,2019],[714,2019]],"region":{"top_left_x":714,"top_left_y":1972,"width":1144,"height":48},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f0e56e0396494d149bc9404ab5c1ec4d","type":"text","conversion_output":false,"parent_id":"eea5059eabcf4d32a9810d11043c468e","text":"control device delivery systems as defined in the device Instructions","text_display":" control device delivery systems as defined in the device Instructions","confidence":1,"confidence_rate":1},{"cnt":[[714,2016],[864,2016],[864,2060],[714,2060]],"region":{"top_left_x":714,"top_left_y":2016,"width":151,"height":45},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bdc483688b1d4423a7021de56d84ba48","type":"text","conversion_output":false,"parent_id":"eea5059eabcf4d32a9810d11043c468e","text":"For Use.","text_display":" For Use.","confidence":0.99951171875,"confidence_rate":0.9999624314366309},{"cnt":[[605,2076],[1808,2076],[1808,2126],[605,2126]],"region":{"top_left_x":605,"top_left_y":2076,"width":1204,"height":50},"line":48,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f653adb97bd74c3c8aba5e489d14fcc1","type":"text","conversion_output":false,"parent_id":"eea5059eabcf4d32a9810d11043c468e","text":"EC23. Subject has current problems with substance abuse (e.g., alcohol,","text_display":"\nEC23. Subject has current problems with substance abuse (e.g., alcohol,","confidence":0.99951171875,"confidence_rate":0.9999935736983052},{"cnt":[[714,2126],[807,2126],[807,2175],[714,2175]],"region":{"top_left_x":714,"top_left_y":2125,"width":93,"height":50},"line":49,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8ad95c57120f448090039e7cff1ab3ec","type":"text","conversion_output":false,"parent_id":"eea5059eabcf4d32a9810d11043c468e","text":"etc.).","text_display":" etc.).","confidence":1,"confidence_rate":1},{"cnt":[[602,2183],[1792,2183],[1792,2232],[602,2232]],"region":{"top_left_x":602,"top_left_y":2182,"width":1190,"height":50},"line":50,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"709f3b0b1dc84badae49a8a0f2cc3003","type":"text","conversion_output":false,"parent_id":"eea5059eabcf4d32a9810d11043c468e","text":"EC24. Subject is participating in another investigational drug or device","text_display":"\nEC24. 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Subject has severe incapacitating dementia. \\\\\nAdditional exclusion criteria apply for subjects considered for enrollment in the CT Imaging substudy of the U.S. Continued Access Study as listed below. \\\\\nAEC1. Subject has eGFR \\(<30 mL / min\\) (chronic kidney disease stage IV or stage V). \\\\\nAEC2. Subject has atrial fibrillation that cannot be rate controlled to ventricular response rate \\(<60 bpm\\). \\\\\nAEC3. Subject is expected to undergo chronic anticoagulation therapy after the TAVR procedure. \\\\\nNote: Subjects treated with short-term anticoagulation postprocedure can be included in the imaging substudy; in these subjects the 30 -day imaging will be performed 30 days after discontinuation of anticoagulation.\n\\end{tabular} \\\\\n\\hline \\multicolumn{2}{|l|}{Statistical Methods} \\\\\n\\hline Analysis Sets & \\begin{tabular}{l}\nAnalysis sets for the randomized cohort are listed below. \\\\\nAs-Treated: This population includes all subjects who sign an Informed Consent Form, are enrolled in the trial, are randomized, and received a study device, but is based on the treatment actually received. \\\\\nIntention-To-Treat (ITT): This population includes all subjects who sign an Informed Consent Form, are enrolled in the trial, and are randomized, whether or not an assigned study device is implanted. \\\\\nImplanted: This population includes all subjects who sign an Informed Consent Form, are enrolled in the trial, and are implanted with the assigned, randomized study device. \\\\\nFor all randomized cohort analysis sets, if a subject receives 2 valves, the subject is assigned to the group corresponding to the first valve received. 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Subject has severe incapacitating dementia. \\\\\nAdditional exclusion criteria apply for subjects considered for enrollment in the CT Imaging substudy of the U.S. Continued Access Study as listed below. \\\\\nAEC1. Subject has eGFR \\(<30 mL / min\\) (chronic kidney disease stage IV or stage V). \\\\\nAEC2. Subject has atrial fibrillation that cannot be rate controlled to ventricular response rate \\(<60 bpm\\). \\\\\nAEC3. Subject is expected to undergo chronic anticoagulation therapy after the TAVR procedure. \\\\\nNote: Subjects treated with short-term anticoagulation postprocedure can be included in the imaging substudy; in these subjects the 30 -day imaging will be performed 30 days after discontinuation of anticoagulation.\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nimplantation. \\\\\nEC26. 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Subject is expected to undergo chronic anticoagulation therapy after the TAVR procedure. \\\\\nNote: Subjects treated with short-term anticoagulation postprocedure can be included in the imaging substudy; in these subjects the 30 -day imaging will be performed 30 days after discontinuation of anticoagulation.\n\\end{tabular}","cell_row":1,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.9610099792480469,"confidence_rate":0.9999482452633967},{"cnt":[[714,527],[941,527],[941,573],[714,573]],"region":{"top_left_x":714,"top_left_y":526,"width":227,"height":48},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"69acceb17b4f41eb9f49c876e0ae9c96","type":"text","conversion_output":false,"parent_id":"b07ebdd8e83647e9bb7faaf5d83d1955","text":"implantation.","text_display":"implantation.","confidence":1,"confidence_rate":1},{"cnt":[[602,581],[1445,581],[1445,633],[602,633]],"region":{"top_left_x":602,"top_left_y":581,"width":844,"height":53},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e33156cf8a9c415a887295a853ec0000","type":"text","conversion_output":false,"parent_id":"b07ebdd8e83647e9bb7faaf5d83d1955","text":"EC26. 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Subject has atrial fibrillation that cannot be rate controlled to","confidence":1,"confidence_rate":1},{"cnt":[[731,969],[1328,969],[1328,1021],[731,1021]],"region":{"top_left_x":730,"top_left_y":968,"width":599,"height":53},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c6feb1bb637f4b61adb960260dfc658b","type":"text","conversion_output":false,"parent_id":"b07ebdd8e83647e9bb7faaf5d83d1955","text":"ventricular response rate \\(<60 bpm\\).","text_display":" ventricular response rate \\(<60 bpm\\).","confidence":0.9956073760986328,"confidence_rate":0.9999021759002172},{"cnt":[[602,1029],[1874,1029],[1874,1078],[602,1078]],"region":{"top_left_x":602,"top_left_y":1028,"width":1272,"height":50},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b651cb66a77448ab8951aa9a778e8ac4","type":"text","conversion_output":false,"parent_id":"b07ebdd8e83647e9bb7faaf5d83d1955","text":"AEC3. Subject is expected to undergo chronic anticoagulation therapy after","text_display":"\nAEC3. Subject is expected to undergo chronic anticoagulation therapy after","confidence":0.9990234375,"confidence_rate":0.9999876324859995},{"cnt":[[731,1078],[1099,1078],[1099,1124],[731,1124]],"region":{"top_left_x":730,"top_left_y":1077,"width":369,"height":48},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9518fe753fff4eb4a1e4354b62ab6547","type":"text","conversion_output":false,"parent_id":"b07ebdd8e83647e9bb7faaf5d83d1955","text":"the TAVR procedure.","text_display":" the TAVR procedure.","confidence":1,"confidence_rate":1},{"cnt":[[731,1127],[1737,1127],[1737,1173],[731,1173]],"region":{"top_left_x":730,"top_left_y":1126,"width":1008,"height":48},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"10b67b56158e404fa8fea43cda3f5779","type":"text","conversion_output":false,"parent_id":"b07ebdd8e83647e9bb7faaf5d83d1955","text":"Note: Subjects treated with short-term anticoagulation post-","text_display":"\nNote: Subjects treated with short-term anticoagulation post","confidence":1,"confidence_rate":1},{"cnt":[[731,1173],[1737,1173],[1737,1222],[731,1222]],"region":{"top_left_x":730,"top_left_y":1173,"width":1008,"height":50},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a5ed2951958d4c27b18a18328a52a64e","type":"text","conversion_output":false,"parent_id":"b07ebdd8e83647e9bb7faaf5d83d1955","text":"procedure can be included in the imaging substudy; in these","text_display":"procedure can be included in the imaging substudy; in these","confidence":1,"confidence_rate":1},{"cnt":[[731,1222],[1743,1222],[1743,1269],[731,1269]],"region":{"top_left_x":730,"top_left_y":1222,"width":1013,"height":47},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d0c627e25a2149ccbf7d0ac4ed76fa51","type":"text","conversion_output":false,"parent_id":"b07ebdd8e83647e9bb7faaf5d83d1955","text":"subjects the 30 -day imaging will be performed 30 days after","text_display":" subjects the 30 -day imaging will be performed 30 days after","confidence":0.9931755065917969,"confidence_rate":0.9999035555418274},{"cnt":[[731,1269],[1317,1269],[1317,1315],[731,1315]],"region":{"top_left_x":730,"top_left_y":1268,"width":588,"height":48},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"595e10bddf4b48588166a59edf726408","type":"text","conversion_output":false,"parent_id":"b07ebdd8e83647e9bb7faaf5d83d1955","text":"discontinuation of anticoagulation.","text_display":" discontinuation of anticoagulation.","confidence":0.99951171875,"confidence_rate":0.9999877900620892},{"cnt":[[299,1362],[1882,1362],[1882,1413],[299,1413]],"region":{"top_left_x":299,"top_left_y":1361,"width":1583,"height":53},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f5fa5e67ce594c8b89c66c8944d72e19","type":"table_spanning_cell","conversion_output":false,"parent_id":"6d3d2b7e39d5422aab904df7ab31e183","children_ids":["eef1218f7b7d414382da2a10a75b0d28"],"text":"","text_display":"Statistical Methods","cell_row":2,"cell_column":0,"cell_row_span":1,"cell_col_span":2},{"cnt":[[308,1362],[657,1362],[657,1408],[308,1408]],"region":{"top_left_x":307,"top_left_y":1361,"width":350,"height":47},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"eef1218f7b7d414382da2a10a75b0d28","type":"simple_cell","conversion_output":false,"parent_id":"f5fa5e67ce594c8b89c66c8944d72e19","text":"Statistical Methods","text_display":"Statistical Methods","cell_row":2,"cell_column":0,"cell_row_span":1,"cell_col_span":2,"confidence":1,"confidence_rate":1},{"cnt":[[310,1460],[548,1460],[548,1509],[310,1509]],"region":{"top_left_x":310,"top_left_y":1459,"width":238,"height":50},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a570407030d54b1c97edef0902a86b35","type":"simple_cell","conversion_output":false,"parent_id":"6d3d2b7e39d5422aab904df7ab31e183","text":"Analysis Sets","text_display":"Analysis Sets","cell_row":3,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[600,1454],[1879,1454],[1879,2475],[600,2475]],"region":{"top_left_x":599,"top_left_y":1454,"width":1281,"height":1021},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2805f3599cd44d83afa821e013ed71ae","type":"complex_cell","conversion_output":false,"parent_id":"6d3d2b7e39d5422aab904df7ab31e183","children_ids":["eb1623bb270246ddb8b6b06a6f793e24","f92b0451a64940faaa0c9fa528889b1e","b7201ce186844028a545e0d748fe3a9c","fe1803850f434ca7b6ca54da5ae92e66","7011f192468c45378ae73292d5be4560","82873ce9e1334f39856a318b7543ab27","0f13f7d64a964bbca0aa870de89258c8","a78db4bc212d4be5a08d90d53286cb9b","0789af8c276b4358a232d7cd2a1aef30","72adcf2276414012943376b7308a579f","86849c525f6540db99c9f1c16e2a1c4a","8cbea0b90ccc4648ac1966ea72fa289e","79c5176875d84b3583b10687b087442a","6cd6b9e6f3314bd7a72295bb06c09e8e","ed7b90a037a04ced93c37bec31cc8fa5","2c0d5fe7e8de4e9a8ccd3cd4a7233b2b","655f20e0cbdd4bb590193fa1458a5593","fc6a402c84ef4fc9bf16aac684f0ab60","c2a2c0f3747343ac9c630fefd8987cff","84201a106e364d2086eeb77fb626f2ff"],"text":"\\begin{tabular}{l}\nAnalysis sets for the randomized cohort are listed below. \\\\\nAs-Treated: This population includes all subjects who sign an Informed Consent Form, are enrolled in the trial, are randomized, and received a study device, but is based on the treatment actually received. \\\\\nIntention-To-Treat (ITT): This population includes all subjects who sign an Informed Consent Form, are enrolled in the trial, and are randomized, whether or not an assigned study device is implanted. \\\\\nImplanted: This population includes all subjects who sign an Informed Consent Form, are enrolled in the trial, and are implanted with the assigned, randomized study device. \\\\\nFor all randomized cohort analysis sets, if a subject receives 2 valves, the subject is assigned to the group corresponding to the first valve received. Among the roll-in (initial cohort with the 23, 25 and 27 mm Lotus), Lotus 21 mm Nested Registry, LOTUS Edge Nested Registry, roll-in with the 29 mm LOTUS Edge, LOTUS Edge 29 mm Nested Registry, and U.S. Continued Access cohorts, for ITT analyses all subjects who sign an Informed Consent Form and are enrolled in the study will be included in the analysis sample, regardless of whether the study device was implanted. The As-Treated population is the same as the Implanted population for these cohorts and includes all subjects who sign an Informed Consent Form\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nAnalysis sets for the randomized cohort are listed below. \\\\\nAs-Treated: This population includes all subjects who sign an Informed Consent Form, are enrolled in the trial, are randomized, and received a study device, but is based on the treatment actually received. \\\\\nIntention-To-Treat (ITT): This population includes all subjects who sign an Informed Consent Form, are enrolled in the trial, and are randomized, whether or not an assigned study device is implanted. \\\\\nImplanted: This population includes all subjects who sign an Informed Consent Form, are enrolled in the trial, and are implanted with the assigned, randomized study device. \\\\\nFor all randomized cohort analysis sets, if a subject receives 2 valves, the subject is assigned to the group corresponding to the first valve received. Among the roll-in (initial cohort with the 23, 25 and 27 mm Lotus), Lotus 21 mm Nested Registry, LOTUS Edge Nested Registry, roll-in with the 29 mm LOTUS Edge, LOTUS Edge 29 mm Nested Registry, and U.S. Continued Access cohorts, for ITT analyses all subjects who sign an Informed Consent Form and are enrolled in the study will be included in the analysis sample, regardless of whether the study device was implanted. The As-Treated population is the same as the Implanted population for these cohorts and includes all subjects who sign an Informed Consent Form\n\\end{tabular}","cell_row":3,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.99951171875,"confidence_rate":0.9999995789651764},{"cnt":[[602,1460],[1557,1460],[1557,1506],[602,1506]],"region":{"top_left_x":602,"top_left_y":1459,"width":956,"height":48},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"eb1623bb270246ddb8b6b06a6f793e24","type":"text","conversion_output":false,"parent_id":"2805f3599cd44d83afa821e013ed71ae","text":"Analysis sets for the randomized cohort are listed below.","text_display":"Analysis sets for the randomized cohort are listed below.","confidence":1,"confidence_rate":1},{"cnt":[[602,1520],[1803,1520],[1803,1566],[602,1566]],"region":{"top_left_x":602,"top_left_y":1519,"width":1201,"height":48},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f92b0451a64940faaa0c9fa528889b1e","type":"text","conversion_output":false,"parent_id":"2805f3599cd44d83afa821e013ed71ae","text":"As-Treated: This population includes all subjects who sign an Informed","text_display":"\nAs-Treated: This population includes all subjects who sign an Informed","confidence":1,"confidence_rate":1},{"cnt":[[605,1566],[1786,1566],[1786,1610],[605,1610]],"region":{"top_left_x":605,"top_left_y":1566,"width":1182,"height":44},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b7201ce186844028a545e0d748fe3a9c","type":"text","conversion_output":false,"parent_id":"2805f3599cd44d83afa821e013ed71ae","text":"Consent Form, are enrolled in the trial, are randomized, and received a","text_display":" Consent Form, are enrolled in the trial, are randomized, and received a","confidence":1,"confidence_rate":1},{"cnt":[[605,1613],[1620,1613],[1620,1662],[605,1662]],"region":{"top_left_x":605,"top_left_y":1612,"width":1015,"height":50},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fe1803850f434ca7b6ca54da5ae92e66","type":"text","conversion_output":false,"parent_id":"2805f3599cd44d83afa821e013ed71ae","text":"study device, but is based on the treatment actually received.","text_display":" study device, but is based on the treatment actually received.","confidence":1,"confidence_rate":1},{"cnt":[[602,1673],[1868,1673],[1868,1719],[602,1719]],"region":{"top_left_x":602,"top_left_y":1672,"width":1267,"height":47},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7011f192468c45378ae73292d5be4560","type":"text","conversion_output":false,"parent_id":"2805f3599cd44d83afa821e013ed71ae","text":"Intention-To-Treat (ITT): This population includes all subjects who sign an","text_display":"\nIntention-To-Treat (ITT): This population includes all subjects who sign an","confidence":1,"confidence_rate":1},{"cnt":[[605,1722],[1770,1722],[1770,1768],[605,1768]],"region":{"top_left_x":605,"top_left_y":1721,"width":1166,"height":48},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"82873ce9e1334f39856a318b7543ab27","type":"text","conversion_output":false,"parent_id":"2805f3599cd44d83afa821e013ed71ae","text":"Informed Consent Form, are enrolled in the trial, and are randomized,","text_display":" Informed Consent Form, are enrolled in the trial, and are randomized,","confidence":1,"confidence_rate":1},{"cnt":[[605,1771],[1503,1771],[1503,1817],[605,1817]],"region":{"top_left_x":605,"top_left_y":1770,"width":898,"height":48},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0f13f7d64a964bbca0aa870de89258c8","type":"text","conversion_output":false,"parent_id":"2805f3599cd44d83afa821e013ed71ae","text":"whether or not an assigned study device is implanted.","text_display":" whether or not an assigned study device is implanted.","confidence":0.99951171875,"confidence_rate":0.9999915793372107},{"cnt":[[602,1825],[1786,1825],[1786,1875],[602,1875]],"region":{"top_left_x":602,"top_left_y":1825,"width":1185,"height":50},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a78db4bc212d4be5a08d90d53286cb9b","type":"text","conversion_output":false,"parent_id":"2805f3599cd44d83afa821e013ed71ae","text":"Implanted: This population includes all subjects who sign an Informed","text_display":"\nImplanted: This population includes all subjects who sign an Informed","confidence":1,"confidence_rate":1},{"cnt":[[602,1875],[1874,1875],[1874,1921],[602,1921]],"region":{"top_left_x":602,"top_left_y":1874,"width":1272,"height":47},"line":48,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0789af8c276b4358a232d7cd2a1aef30","type":"text","conversion_output":false,"parent_id":"2805f3599cd44d83afa821e013ed71ae","text":"Consent Form, are enrolled in the trial, and are implanted with the assigned,","text_display":" Consent Form, are enrolled in the trial, and are implanted with the assigned,","confidence":1,"confidence_rate":1},{"cnt":[[605,1924],[1033,1924],[1033,1970],[605,1970]],"region":{"top_left_x":605,"top_left_y":1923,"width":429,"height":47},"line":49,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"72adcf2276414012943376b7308a579f","type":"text","conversion_output":false,"parent_id":"2805f3599cd44d83afa821e013ed71ae","text":"randomized study device.","text_display":" randomized study device.","confidence":1,"confidence_rate":1},{"cnt":[[602,1981],[1830,1981],[1830,2030],[602,2030]],"region":{"top_left_x":602,"top_left_y":1980,"width":1229,"height":51},"line":50,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"86849c525f6540db99c9f1c16e2a1c4a","type":"text","conversion_output":false,"parent_id":"2805f3599cd44d83afa821e013ed71ae","text":"For all randomized cohort analysis sets, if a subject 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received.","confidence":1,"confidence_rate":1},{"cnt":[[605,2087],[1841,2087],[1841,2134],[605,2134]],"region":{"top_left_x":605,"top_left_y":2087,"width":1236,"height":47},"line":52,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"79c5176875d84b3583b10687b087442a","type":"text","conversion_output":false,"parent_id":"2805f3599cd44d83afa821e013ed71ae","text":"Among the roll-in (initial cohort with the 23, 25 and 27 mm Lotus), Lotus","text_display":" Among the roll-in (initial cohort with the 23, 25 and 27 mm Lotus), Lotus","confidence":1,"confidence_rate":1},{"cnt":[[605,2136],[1803,2136],[1803,2183],[605,2183]],"region":{"top_left_x":605,"top_left_y":2136,"width":1198,"height":47},"line":53,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6cd6b9e6f3314bd7a72295bb06c09e8e","type":"text","conversion_output":false,"parent_id":"2805f3599cd44d83afa821e013ed71ae","text":"21 mm Nested Registry, LOTUS Edge Nested Registry, roll-in with 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This endpoint will also be analyzed for the ITT and as-treated analysis sets.\n\\end{tabular} \\\\\n\\hline \\begin{tabular}{l}\nSample Size Parameters for the Primary \\\\\nSafety \\\\\nEndpoint\n\\end{tabular} & \\begin{tabular}{l}\n- Expected Lotus Valve (test) rate \\(=40 \\%\\) \\\\\n- Expected CoreValve (control) rate \\(=40 \\%\\) \\\\\n- Non-inferiority margin \\((\\Delta)=10.5 \\%\\) \\\\\n- Test significance level \\((\\alpha)=0.025\\) ( 1 -sided) \\\\\n- Test : Control ratio = 2:1 \\\\\n- Expected rate of attrition \\(=5 \\%\\) \\\\\n- Given enrollment of 912 subjects ( 608 Lotus Valve, 304 CoreValve) and \\(5 \\%\\) attrition, there is approximately \\(85 \\%\\) power to show non-inferiority with the given expected rates\n\\end{tabular} \\\\\n\\hline Success Criteria for the Primary Safety Endpoint & If the \\(P\\) value from the Farrington-Manning standardized test is \\(<0.025\\), the rate of the primary safety endpoint for the Lotus Valve will be concluded to be non-inferior to the CoreValve rate. This corresponds to the one-sided upper 97.5\\% confidence bound on the difference between treatment groups (Lotus Valve minus CoreValve) for the observed rate of the primary safety endpoint being less than delta. \\\\\n\\hline Primary Effectiveness & The primary effectiveness endpoint (composite of all-cause mortality, disabling stroke, or moderate or greater paravalvular aortic regurgitation \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|}\n\\hline \\multicolumn{2}{|c|}{REPRISE III: REpositionable Percutaneous Replacement of Stenotic Aortic Valve through Implantation of Lotus \\({ }^{\\text {TM }}\\) Valve System - Randomized Clinical Evaluation} \\\\\n\\hline & and are implanted with the Lotus Valve. \\\\\n\\hline \\begin{tabular}{l}\nPrimary \\\\\nSafety \\\\\nEndpoint \\\\\nStatistical \\\\\nHypothesis\n\\end{tabular} & The primary safety endpoint (composite of all-cause mortality, stroke, lifethreatening and major bleeding events, stage 2 or 3 acute kidney injury, or major vascular complications at 30 days) rate for the Lotus Valve is noninferior to that for CoreValve. \\\\\n\\hline \\begin{tabular}{l}\nStatistical Test Method for the Primary \\\\\nSafety \\\\\nEndpoint\n\\end{tabular} & \\begin{tabular}{l}\nA Farrington-Manning standardized test will be used to test the one-sided hypothesis of non-inferiority of the Lotus Valve versus CoreValve: \\\\\n\\(H _{0}: P _{\\text {S_Lotus }}\\) minus \\(P _{\\text {S_Control }} \\geq \\Delta\\) (Inferior) \\\\\n\\(H _{1}: P _{\\text {S_Lotus }}\\) minus \\(P _{\\text {S_Control }}<\\Delta\\) (Non-inferior) \\\\\nwhere \\(P _{ S \\_ \\text {Lotus }}\\) and \\(P _{ S \\_ \\text {Control }}\\) are the rates of the primary safety endpoint for the Lotus Valve group (test) and the CoreValve group (control), respectively, and \\(\\Delta\\) (delta) is the non-inferiority margin. \\\\\nThe primary analysis set for the primary safety endpoint is the implanted analysis set. 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\\\\\nHypothesis\n\\end{tabular}","cell_row":2,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[308,622],[464,622],[464,668],[308,668]],"region":{"top_left_x":308,"top_left_y":621,"width":156,"height":48},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a5298ecb7e5749edb9e94938eeb4254e","type":"text","conversion_output":false,"parent_id":"95c5ee2d98e5419a845e3d658547645f","text":"Primary","text_display":"Primary","confidence":1,"confidence_rate":1},{"cnt":[[308,671],[426,671],[426,717],[308,717]],"region":{"top_left_x":308,"top_left_y":671,"width":118,"height":47},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e50646318b6644b49660aaa13406b135","type":"text","conversion_output":false,"parent_id":"95c5ee2d98e5419a845e3d658547645f","text":"Safety","text_display":"\nSafety","confidence":1,"confidence_rate":1},{"cnt":[[308,720],[486,720],[486,764],[308,764]],"region":{"top_left_x":308,"top_left_y":720,"width":178,"height":44},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"db01e5a748c14c61861d40529a6c52fb","type":"text","conversion_output":false,"parent_id":"95c5ee2d98e5419a845e3d658547645f","text":"Endpoint","text_display":"\nEndpoint","confidence":1,"confidence_rate":1},{"cnt":[[308,764],[491,764],[491,805],[308,805]],"region":{"top_left_x":308,"top_left_y":763,"width":184,"height":42},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a119f68af1a84b1799427f9a982d280c","type":"text","conversion_output":false,"parent_id":"95c5ee2d98e5419a845e3d658547645f","text":"Statistical","text_display":"\nStatistical","confidence":1,"confidence_rate":1},{"cnt":[[308,813],[513,813],[513,859],[308,859]],"region":{"top_left_x":308,"top_left_y":812,"width":205,"height":48},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bf3eecb80f73486199462759ab185279","type":"text","conversion_output":false,"parent_id":"95c5ee2d98e5419a845e3d658547645f","text":"Hypothesis","text_display":"\nHypothesis","confidence":1,"confidence_rate":1},{"cnt":[[598,616],[1861,616],[1861,810],[598,810]],"region":{"top_left_x":597,"top_left_y":616,"width":1264,"height":195},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"38f786fb03a843aaa633693cad4da3e4","type":"complex_cell","conversion_output":false,"parent_id":"51c4b3655ca64c77aba166a3b6346fde","children_ids":["685dd34395854dd6a47cebd343c4c379","f8cdd3f1c9e24cc28045d258a67ca510","0d60ade490eb47b9b2b5ebce555fe5be","e5b945e514284ca4b1879bb22b4b42a3"],"text":"The primary safety endpoint (composite of all-cause mortality, stroke, lifethreatening and major bleeding events, stage 2 or 3 acute kidney injury, or major vascular complications at 30 days) rate for the Lotus Valve is noninferior to that for CoreValve.","text_display":"The primary safety endpoint (composite of all-cause mortality, stroke, lifethreatening and major bleeding events, stage 2 or 3 acute kidney injury, or major vascular complications at 30 days) rate for the Lotus Valve is noninferior to that for CoreValve.","cell_row":2,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.9716796875,"confidence_rate":0.9999113339667415},{"cnt":[[603,622],[1861,622],[1861,668],[603,668]],"region":{"top_left_x":603,"top_left_y":621,"width":1258,"height":48},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"685dd34395854dd6a47cebd343c4c379","type":"text","conversion_output":false,"parent_id":"38f786fb03a843aaa633693cad4da3e4","text":"The primary safety endpoint (composite of all-cause mortality, stroke, life-","text_display":"The primary safety endpoint (composite of all-cause mortality, stroke, life","confidence":1,"confidence_rate":1},{"cnt":[[603,668],[1850,668],[1850,717],[603,717]],"region":{"top_left_x":603,"top_left_y":668,"width":1247,"height":50},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f8cdd3f1c9e24cc28045d258a67ca510","type":"text","conversion_output":false,"parent_id":"38f786fb03a843aaa633693cad4da3e4","text":"threatening and major bleeding events, stage 2 or 3 acute kidney injury, or","text_display":"threatening and major bleeding events, stage 2 or 3 acute kidney injury, or","confidence":1,"confidence_rate":1},{"cnt":[[603,715],[1828,715],[1828,764],[603,764]],"region":{"top_left_x":603,"top_left_y":714,"width":1226,"height":50},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0d60ade490eb47b9b2b5ebce555fe5be","type":"text","conversion_output":false,"parent_id":"38f786fb03a843aaa633693cad4da3e4","text":"major vascular complications at 30 days) rate for the Lotus Valve is non-","text_display":" major vascular complications at 30 days) rate for the Lotus Valve is non","confidence":0.9716796875,"confidence_rate":0.9996453830341704},{"cnt":[[603,764],[1108,764],[1108,805],[603,805]],"region":{"top_left_x":603,"top_left_y":763,"width":505,"height":42},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e5b945e514284ca4b1879bb22b4b42a3","type":"text","conversion_output":false,"parent_id":"38f786fb03a843aaa633693cad4da3e4","text":"inferior to that for CoreValve.","text_display":"inferior to that for CoreValve.","confidence":1,"confidence_rate":1},{"cnt":[[306,906],[589,906],[589,1148],[306,1148]],"region":{"top_left_x":305,"top_left_y":905,"width":285,"height":244},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"378bf809b3e243d99a3657e3b6cbd82f","type":"complex_cell","conversion_output":false,"parent_id":"51c4b3655ca64c77aba166a3b6346fde","children_ids":["3af5996490534f2d9ff4635cebf7fc0b","60c384fc2d6c4ab8a56e19f2f8d649b9","4c03d8c332444cd3b326902b4c59fcc4","09ea124da41c454dbd0518b96662417b","a30f9d202c0544229ef15bcc850c8c1a"],"text":"\\begin{tabular}{l}\nStatistical Test Method for the Primary \\\\\nSafety \\\\\nEndpoint\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nStatistical Test Method for the Primary \\\\\nSafety \\\\\nEndpoint\n\\end{tabular}","cell_row":3,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[308,911],[581,911],[581,952],[308,952]],"region":{"top_left_x":308,"top_left_y":911,"width":274,"height":42},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3af5996490534f2d9ff4635cebf7fc0b","type":"text","conversion_output":false,"parent_id":"378bf809b3e243d99a3657e3b6cbd82f","text":"Statistical Test","text_display":"Statistical Test","confidence":1,"confidence_rate":1},{"cnt":[[308,960],[584,960],[584,998],[308,998]],"region":{"top_left_x":308,"top_left_y":960,"width":276,"height":39},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"60c384fc2d6c4ab8a56e19f2f8d649b9","type":"text","conversion_output":false,"parent_id":"378bf809b3e243d99a3657e3b6cbd82f","text":"Method for the","text_display":" Method for 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Farrington-Manning standardized test will be used to test the one-sided hypothesis of non-inferiority of the Lotus Valve versus CoreValve: \\\\\n\\(H _{0}: P _{\\text {S_Lotus }}\\) minus \\(P _{\\text {S_Control }} \\geq \\Delta\\) (Inferior) \\\\\n\\(H _{1}: P _{\\text {S_Lotus }}\\) minus \\(P _{\\text {S_Control }}<\\Delta\\) (Non-inferior) \\\\\nwhere \\(P _{ S \\_ \\text {Lotus }}\\) and \\(P _{ S \\_ \\text {Control }}\\) are the rates of the primary safety endpoint for the Lotus Valve group (test) and the CoreValve group (control), respectively, and \\(\\Delta\\) (delta) is the non-inferiority margin. \\\\\nThe primary analysis set for the primary safety endpoint is the implanted analysis set. This endpoint will also be analyzed for the ITT and as-treated analysis sets.\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nA Farrington-Manning standardized test will be used to test the one-sided hypothesis of non-inferiority of the Lotus Valve versus CoreValve: \\\\\n\\(H _{0}: P _{\\text {S_Lotus }}\\) minus \\(P _{\\text {S_Control }} \\geq \\Delta\\) (Inferior) \\\\\n\\(H _{1}: P _{\\text {S_Lotus }}\\) minus \\(P _{\\text {S_Control }}<\\Delta\\) (Non-inferior) \\\\\nwhere \\(P _{ S \\_ \\text {Lotus }}\\) and \\(P _{ S \\_ \\text {Control }}\\) are the rates of the primary safety endpoint for the Lotus Valve group (test) and the CoreValve group (control), respectively, and \\(\\Delta\\) (delta) is the non-inferiority margin. \\\\\nThe primary analysis set for the primary safety endpoint is the implanted analysis set. This endpoint will also be analyzed for the ITT and as-treated analysis sets.\n\\end{tabular}","cell_row":3,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.5755342793418095,"confidence_rate":0.9995329606149934},{"cnt":[[603,908],[1839,908],[1839,955],[603,955]],"region":{"top_left_x":603,"top_left_y":908,"width":1236,"height":47},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"284f21bde652437795af6bd7f86ffd4e","type":"text","conversion_output":false,"parent_id":"995f73f6fa2c490ebf13ea24061c2b25","text":"A Farrington-Manning standardized test will be used to test the one-sided","text_display":"A Farrington-Manning standardized test will be used to test the one-sided","confidence":1,"confidence_rate":1},{"cnt":[[603,955],[1730,955],[1730,1004],[603,1004]],"region":{"top_left_x":603,"top_left_y":954,"width":1127,"height":50},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0a75e34b7e714045b9d5c9d0af6e7672","type":"text","conversion_output":false,"parent_id":"995f73f6fa2c490ebf13ea24061c2b25","text":"hypothesis of non-inferiority of the Lotus Valve versus CoreValve:","text_display":" hypothesis of non-inferiority of the Lotus Valve versus CoreValve:","confidence":1,"confidence_rate":1},{"cnt":[[685,1015],[1370,1015],[1370,1064],[685,1064]],"region":{"top_left_x":684,"top_left_y":1014,"width":686,"height":50},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"59eb615a04e74ff1ab783141a7c1e196","type":"text","conversion_output":false,"parent_id":"995f73f6fa2c490ebf13ea24061c2b25","text":"\\(H _{0}: P _{\\text {S_Lotus }}\\) minus \\(P _{\\text {S_Control }} \\geq \\Delta\\) (Inferior)","text_display":"\n\\(H _{0}: P _{\\text {S_Lotus }}\\) minus \\(P _{\\text {S_Control }} \\geq \\Delta\\) (Inferior)","confidence":0.9917066079797223,"confidence_rate":0.9999053684150411},{"cnt":[[685,1072],[1452,1072],[1452,1121],[685,1121]],"region":{"top_left_x":684,"top_left_y":1072,"width":768,"height":50},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"54fe16cb103c4e79acecdd9fa4f1eba7","type":"text","conversion_output":false,"parent_id":"995f73f6fa2c490ebf13ea24061c2b25","text":"\\(H _{1}: P _{\\text {S_Lotus }}\\) minus \\(P _{\\text {S_Control }}<\\Delta\\) (Non-inferior)","text_display":"\n\\(H _{1}: P _{\\text {S_Lotus }}\\) minus \\(P _{\\text {S_Control }}<\\Delta\\) (Non-inferior)","confidence":0.9883316986548984,"confidence_rate":0.9998724330265476},{"cnt":[[603,1129],[1844,1129],[1844,1181],[603,1181]],"region":{"top_left_x":603,"top_left_y":1129,"width":1242,"height":53},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4ef2fa6f575a45da8c1732c45187ee9e","type":"text","conversion_output":false,"parent_id":"995f73f6fa2c490ebf13ea24061c2b25","text":"where \\(P _{ S \\_ \\text {Lotus }}\\) and \\(P _{ S \\_ \\text {Control }}\\) are the rates of the primary safety endpoint for","text_display":"\nwhere \\(P _{ S \\_ \\text {Lotus }}\\) and \\(P _{ S \\_ \\text {Control }}\\) are the rates of the primary safety endpoint for","confidence":0.5755342793418095,"confidence_rate":0.9955901003838094},{"cnt":[[603,1179],[1675,1179],[1675,1225],[603,1225]],"region":{"top_left_x":603,"top_left_y":1178,"width":1073,"height":47},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"68225d8d81974d09a26271e7bdd48297","type":"text","conversion_output":false,"parent_id":"995f73f6fa2c490ebf13ea24061c2b25","text":"the Lotus Valve group (test) and the CoreValve group (control),","text_display":" the Lotus Valve group (test) and the CoreValve group (control),","confidence":1,"confidence_rate":1},{"cnt":[[603,1228],[1539,1228],[1539,1274],[603,1274]],"region":{"top_left_x":603,"top_left_y":1227,"width":936,"height":47},"line":48,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"48c7b9659c6e4f15ba953a2badbee5e1","type":"text","conversion_output":false,"parent_id":"995f73f6fa2c490ebf13ea24061c2b25","text":"respectively, and \\(\\Delta\\) (delta) is the non-inferiority margin.","text_display":" respectively, and \\(\\Delta\\) (delta) is the non-inferiority margin.","confidence":0.998046875,"confidence_rate":0.999970378698783},{"cnt":[[603,1293],[1828,1293],[1828,1345],[603,1345]],"region":{"top_left_x":603,"top_left_y":1293,"width":1226,"height":52},"line":49,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"335c50d129fd438dbd8f539bd7aa3053","type":"text","conversion_output":false,"parent_id":"995f73f6fa2c490ebf13ea24061c2b25","text":"The primary analysis set for the primary safety endpoint is the implanted","text_display":"\nThe primary analysis set for the primary safety endpoint is the implanted","confidence":1,"confidence_rate":1},{"cnt":[[603,1342],[1853,1342],[1853,1389],[603,1389]],"region":{"top_left_x":603,"top_left_y":1342,"width":1250,"height":47},"line":50,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fa690ec5d5f647d7a4a484e2b51272f4","type":"text","conversion_output":false,"parent_id":"995f73f6fa2c490ebf13ea24061c2b25","text":"analysis set. This endpoint will also be analyzed for the ITT and as-treated","text_display":" analysis set. This endpoint will also be analyzed for the ITT and as-treated","confidence":1,"confidence_rate":1},{"cnt":[[603,1391],[824,1391],[824,1438],[603,1438]],"region":{"top_left_x":603,"top_left_y":1391,"width":222,"height":47},"line":51,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"56a1b71a70694a11b365a64f49f11cc2","type":"text","conversion_output":false,"parent_id":"995f73f6fa2c490ebf13ea24061c2b25","text":"analysis sets.","text_display":" analysis sets.","confidence":1,"confidence_rate":1},{"cnt":[[306,1484],[535,1484],[535,1776],[306,1776]],"region":{"top_left_x":305,"top_left_y":1484,"width":230,"height":293},"line":52,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"aca2a527db3a42a0af4219961eca06ef","type":"complex_cell","conversion_output":false,"parent_id":"51c4b3655ca64c77aba166a3b6346fde","children_ids":["d6b4cdcceb054104abb948fbad1a3b51","5d82e342fe5c4b7ea303f9f3ee5805c6","13138604c95e428aa94eb279aff3905b","7e5a793a258a4d168a0878631375e23e","13453feaf81a4d38b3d64e82ccda3546","a3f2f4fe90da488d9e296ceaeae42139"],"text":"\\begin{tabular}{l}\nSample Size Parameters for the Primary \\\\\nSafety \\\\\nEndpoint\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nSample Size Parameters for the Primary \\\\\nSafety 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If non-inferiority is shown for the Lotus group for the primary safety and primary effectiveness endpoints, superiority is shown for the secondary endpoint, and the rate for the Lotus group is less than the rate for the CoreValve group for the primary effectiveness endpoint, then a test of superiority will be performed for the primary effectiveness endpoint. \\\\\n\\hline Statistical Test Method for the Primary Effectiveness Endpoint -NonInferiority & \\begin{tabular}{l}\nA Farrington-Manning standardized test will be used to test the one-sided hypothesis of non-inferiority of the Lotus Valve versus CoreValve:\n\\[\n\\begin{aligned}\n& H_{0}: P_{E \\_ \\text {Lotus }} \\text { minus } P_{E \\_ \\text {Control }} \\geq \\Delta \\text { (Inferior) } \\\\\n& H_{1}: P_{E \\_ \\text {Lotus }} \\text { minus } P_{E \\_ \\text {Control }}<\\Delta \\text { (Non-inferior) }\n\\end{aligned}\n\\] \\\\\nwhere \\(P _{ E \\_ \\text {Lotus }}\\) and \\(P _{ E \\_ \\text {Control }}\\) correspond to the rates of the primary effectiveness endpoint for the Lotus Valve group (test) and the CoreValve group (control), respectively. \\\\\nThe primary analysis set for the primary effectiveness endpoint is the implanted analysis set. This endpoint will also be analyzed for the ITT and as-treated analysis sets.\n\\end{tabular} \\\\\n\\hline Sample Size Parameters for the Primary Effectiveness Endpoint -NonInferiority & \\begin{tabular}{l}\n- Expected Lotus Valve (test) rate \\(P _{ E \\_ \\text {Lotus }}=32 \\%\\) \\\\\n- Expected CoreValve (control) rate \\(P _{\\text {E_Control }}=32 \\%\\) \\\\\n- Non-inferiority margin \\((\\Delta)=9.5 \\%\\) \\\\\n- Test significance level \\((\\alpha)=0.025\\) ( 1 -sided) \\\\\n- Test : Control ratio = 2:1 \\\\\n- Power \\((1-\\beta)=80 \\%\\) \\\\\n- Total number of evaluable subjects \\(=819\\) \\\\\n- Expected rate of attrition \\(=10 \\%\\) \\\\\n\\(N =912\\) subjects (608 Lotus Valve, 304 CoreValve)\n\\end{tabular} \\\\\n\\hline Success Criteria for the Primary Effectiveness Endpoint -NonInferiority & If the \\(P\\) value from the Farrington-Manning standardized test is \\(<0.025\\), the rate of the primary effectiveness endpoint for the Lotus Valve will be concluded to be non-inferior to the CoreValve rate. 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Farrington-Manning standardized test will be used to test the one-sided hypothesis of non-inferiority of the Lotus Valve versus CoreValve:\n\\[\n\\begin{aligned}\n& H_{0}: P_{E \\_ \\text {Lotus }} \\text { minus } P_{E \\_ \\text {Control }} \\geq \\Delta \\text { (Inferior) } \\\\\n& H_{1}: P_{E \\_ \\text {Lotus }} \\text { minus } P_{E \\_ \\text {Control }}<\\Delta \\text { (Non-inferior) }\n\\end{aligned}\n\\] \\\\\nwhere \\(P _{ E \\_ \\text {Lotus }}\\) and \\(P _{ E \\_ \\text {Control }}\\) correspond to the rates of the primary effectiveness endpoint for the Lotus Valve group (test) and the CoreValve group (control), respectively. \\\\\nThe primary analysis set for the primary effectiveness endpoint is the implanted analysis set. This endpoint will also be analyzed for the ITT and as-treated analysis sets.\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nA Farrington-Manning standardized test will be used to test the one-sided hypothesis of non-inferiority of the Lotus Valve versus CoreValve:\n\\[\n\\begin{aligned}\n& H_{0}: P_{E \\_ \\text {Lotus }} \\text { minus } P_{E \\_ \\text {Control }} \\geq \\Delta \\text { (Inferior) } \\\\\n& H_{1}: P_{E \\_ \\text {Lotus }} \\text { minus } P_{E \\_ \\text {Control }}<\\Delta \\text { (Non-inferior) }\n\\end{aligned}\n\\] \\\\\nwhere \\(P _{ E \\_ \\text {Lotus }}\\) and \\(P _{ E \\_ \\text {Control }}\\) correspond to the rates of the primary effectiveness endpoint for the Lotus Valve group (test) and the CoreValve group (control), respectively. \\\\\nThe primary analysis set for the primary effectiveness endpoint is the implanted analysis set. This endpoint will also be analyzed for the ITT and as-treated analysis sets.\n\\end{tabular}","cell_row":2,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.2769253933921588,"confidence_rate":0.998879065198416},{"cnt":[[605,909],[1838,909],[1838,955],[605,955]],"region":{"top_left_x":605,"top_left_y":908,"width":1234,"height":48},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"20982a0e988346b2a47e8f79f45823d1","type":"text","conversion_output":false,"parent_id":"6a9f5a7675654a798141cceec4357610","text":"A Farrington-Manning standardized test will be used to test the one-sided","text_display":"A Farrington-Manning standardized test will be used to test the one-sided","confidence":1,"confidence_rate":1},{"cnt":[[605,958],[1729,958],[1729,1004],[605,1004]],"region":{"top_left_x":605,"top_left_y":957,"width":1125,"height":48},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ca1909b3ecfc4a169be6b6de99e750d7","type":"text","conversion_output":false,"parent_id":"6a9f5a7675654a798141cceec4357610","text":"hypothesis of non-inferiority of the Lotus Valve versus CoreValve:","text_display":" hypothesis of non-inferiority of the Lotus Valve versus CoreValve:","confidence":1,"confidence_rate":1},{"cnt":[[681,1012],[1459,1012],[1459,1124],[681,1124]],"region":{"top_left_x":681,"top_left_y":1012,"width":779,"height":113},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ac5346ab814b4a8986ca16fac7874e71","type":"math","conversion_output":false,"parent_id":"6a9f5a7675654a798141cceec4357610","text":"\\[\n\\begin{aligned}\n& H_{0}: P_{E \\_ \\text {Lotus }} \\text { minus } P_{E \\_ \\text {Control }} \\geq \\Delta \\text { (Inferior) } \\\\\n& H_{1}: P_{E \\_ \\text {Lotus }} \\text { minus } P_{E \\_ \\text {Control }}<\\Delta \\text { (Non-inferior) }\n\\end{aligned}\n\\]","text_display":"\n\\[\n\\begin{aligned}\n& H_{0}: P_{E \\_ \\text {Lotus }} \\text { minus } P_{E \\_ \\text {Control }} \\geq \\Delta \\text { (Inferior) } \\\\\n& H_{1}: P_{E \\_ \\text {Lotus }} \\text { minus } P_{E \\_ \\text {Control }}<\\Delta \\text { (Non-inferior) }\n\\end{aligned}\n\\]","confidence":0.2769253933921588,"confidence_rate":0.9936636885998497},{"cnt":[[605,1132],[1699,1132],[1699,1179],[605,1179]],"region":{"top_left_x":605,"top_left_y":1132,"width":1095,"height":47},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"aa86ac7a6aeb4b2b9323a58cf8c8ddec","type":"text","conversion_output":false,"parent_id":"6a9f5a7675654a798141cceec4357610","text":"where \\(P _{ E \\_ \\text {Lotus }}\\) and \\(P _{ E \\_ \\text {Control }}\\) correspond to the rates of the primary","text_display":"\nwhere \\(P _{ E \\_ \\text {Lotus }}\\) and \\(P _{ E \\_ \\text {Control }}\\) correspond to the rates of the primary","confidence":0.650623546132007,"confidence_rate":0.9962693754901466},{"cnt":[[605,1179],[1849,1179],[1849,1228],[605,1228]],"region":{"top_left_x":605,"top_left_y":1178,"width":1245,"height":50},"line":48,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"700a848dd4024f90bb0d706486b595e1","type":"text","conversion_output":false,"parent_id":"6a9f5a7675654a798141cceec4357610","text":"effectiveness endpoint for the Lotus Valve group (test) and the CoreValve","text_display":" effectiveness endpoint for the Lotus Valve group (test) and the CoreValve","confidence":1,"confidence_rate":1},{"cnt":[[605,1228],[1096,1228],[1096,1277],[605,1277]],"region":{"top_left_x":605,"top_left_y":1227,"width":492,"height":50},"line":49,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5ed9d677e6ba43ff9e9bb7bd2bec3b15","type":"text","conversion_output":false,"parent_id":"6a9f5a7675654a798141cceec4357610","text":"group (control), respectively.","text_display":" group (control), respectively.","confidence":1,"confidence_rate":1},{"cnt":[[605,1296],[1765,1296],[1765,1342],[605,1342]],"region":{"top_left_x":605,"top_left_y":1296,"width":1160,"height":47},"line":50,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"52c69166464f4fde82a083861779c6e4","type":"text","conversion_output":false,"parent_id":"6a9f5a7675654a798141cceec4357610","text":"The primary analysis set for the primary effectiveness endpoint is the","text_display":"\nThe primary analysis set for the primary effectiveness endpoint is the","confidence":1,"confidence_rate":1},{"cnt":[[605,1345],[1860,1345],[1860,1392],[605,1392]],"region":{"top_left_x":605,"top_left_y":1345,"width":1256,"height":47},"line":51,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"667827b23b4443e79978766065b1b6b6","type":"text","conversion_output":false,"parent_id":"6a9f5a7675654a798141cceec4357610","text":"implanted analysis set. This endpoint will also be analyzed for the ITT and","text_display":" implanted analysis set. This endpoint will also be analyzed for the ITT and","confidence":1,"confidence_rate":1},{"cnt":[[605,1394],[1001,1394],[1001,1441],[605,1441]],"region":{"top_left_x":605,"top_left_y":1394,"width":396,"height":47},"line":52,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"156a786839ca4ef0b7faf88e079e4b8e","type":"text","conversion_output":false,"parent_id":"6a9f5a7675654a798141cceec4357610","text":"as-treated analysis sets.","text_display":" as-treated analysis 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-NonInferiority","cell_row":3,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":0.99951171875,"confidence_rate":0.9999959300041316},{"cnt":[[310,1487],[531,1487],[531,1533],[310,1533]],"region":{"top_left_x":310,"top_left_y":1487,"width":222,"height":47},"line":54,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"42213548fbb14d36a1012e2b0e331f61","type":"text","conversion_output":false,"parent_id":"1219ac87995c4ed9a4aa19d164736d70","text":"Sample Size","text_display":"Sample Size","confidence":1,"confidence_rate":1},{"cnt":[[310,1536],[520,1536],[520,1577],[310,1577]],"region":{"top_left_x":310,"top_left_y":1536,"width":211,"height":42},"line":55,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b25655865c8b45aca596c4ca812266c4","type":"text","conversion_output":false,"parent_id":"1219ac87995c4ed9a4aa19d164736d70","text":"Parameters","text_display":" Parameters","confidence":1,"confidence_rate":1},{"cnt":[[310,1585],[436,1585],[436,1626],[310,1626]],"region":{"top_left_x":310,"top_left_y":1585,"width":126,"height":42},"line":56,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6fa9ae19bdfb48a388f460b8db676531","type":"text","conversion_output":false,"parent_id":"1219ac87995c4ed9a4aa19d164736d70","text":"for the","text_display":" for the","confidence":1,"confidence_rate":1},{"cnt":[[310,1634],[466,1634],[466,1681],[310,1681]],"region":{"top_left_x":310,"top_left_y":1634,"width":156,"height":47},"line":57,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8ce45d9710d04793a1abdd1555d6b626","type":"text","conversion_output":false,"parent_id":"1219ac87995c4ed9a4aa19d164736d70","text":"Primary","text_display":" Primary","confidence":1,"confidence_rate":1},{"cnt":[[310,1681],[548,1681],[548,1719],[310,1719]],"region":{"top_left_x":310,"top_left_y":1680,"width":238,"height":39},"line":58,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"531b44aa0ed345f1892b4bd5057565a4","type":"text","conversion_output":false,"parent_id":"1219ac87995c4ed9a4aa19d164736d70","text":"Effectiveness","text_display":" Effectiveness","confidence":1,"confidence_rate":1},{"cnt":[[310,1733],[515,1733],[515,1779],[310,1779]],"region":{"top_left_x":310,"top_left_y":1732,"width":205,"height":48},"line":59,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"27c914d3bb0843c7a083f053fcd478ac","type":"text","conversion_output":false,"parent_id":"1219ac87995c4ed9a4aa19d164736d70","text":"Endpoint -","text_display":" Endpoint -","confidence":0.99951171875,"confidence_rate":0.9999674404968648},{"cnt":[[310,1776],[409,1776],[409,1820],[310,1820]],"region":{"top_left_x":310,"top_left_y":1776,"width":99,"height":44},"line":60,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0a3b653aae744f94bef8720a137af2d2","type":"text","conversion_output":false,"parent_id":"1219ac87995c4ed9a4aa19d164736d70","text":"Non-","text_display":"Non","confidence":1,"confidence_rate":1},{"cnt":[[310,1828],[504,1828],[504,1872],[310,1872]],"region":{"top_left_x":310,"top_left_y":1828,"width":195,"height":44},"line":61,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"03bb43b9c3f2459f8be15fdd05ed6afe","type":"text","conversion_output":false,"parent_id":"1219ac87995c4ed9a4aa19d164736d70","text":"Inferiority","text_display":"Inferiority","confidence":1,"confidence_rate":1},{"cnt":[[600,1482],[1505,1482],[1505,2011],[600,2011]],"region":{"top_left_x":599,"top_left_y":1481,"width":907,"height":530},"line":62,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"26b7c670faae46f495a98702c07523d8","type":"complex_cell","conversion_output":false,"parent_id":"7541be0965804fe690c62847ee648ce8","children_ids":["c6952d1dcd7e453fb8184da69fca36fe","a420c02a45624e14bab7e75b55eb5526","7b8c5214b73a41cda628e1e65982e1e6","068e6b0acec040229f65fc9ab6e3338c","3daaca9423464bb1a45906b283ffd232","cb3a980786694300bf10de8d7e6eeba0","a6a463f88a2f492eb44fbdfbbdc27557","fbcec6c8de0246a8bb30925ebddbeff0","9b0c6e726f9948a9a16c87e00c498280"],"text":"\\begin{tabular}{l}\n- Expected Lotus Valve (test) rate \\(P _{ E \\_ \\text {Lotus }}=32 \\%\\) \\\\\n- Expected CoreValve (control) rate \\(P _{\\text {E_Control }}=32 \\%\\) \\\\\n- Non-inferiority margin \\((\\Delta)=9.5 \\%\\) \\\\\n- Test significance level \\((\\alpha)=0.025\\) ( 1 -sided) \\\\\n- Test : Control ratio = 2:1 \\\\\n- Power \\((1-\\beta)=80 \\%\\) \\\\\n- Total number of evaluable subjects \\(=819\\) \\\\\n- Expected rate of attrition \\(=10 \\%\\) \\\\\n\\(N =912\\) subjects (608 Lotus Valve, 304 CoreValve)\n\\end{tabular}","text_display":"\\begin{tabular}{l}\n- Expected Lotus Valve (test) rate \\(P _{ E \\_ \\text {Lotus }}=32 \\%\\) \\\\\n- Expected CoreValve (control) rate \\(P _{\\text {E_Control }}=32 \\%\\) \\\\\n- Non-inferiority margin \\((\\Delta)=9.5 \\%\\) \\\\\n- Test significance level \\((\\alpha)=0.025\\) ( 1 -sided) \\\\\n- Test : Control ratio = 2:1 \\\\\n- Power \\((1-\\beta)=80 \\%\\) \\\\\n- Total number of evaluable subjects \\(=819\\) \\\\\n- Expected rate of 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Randomized Clinical Evaluation} \\\\\n\\hline Statistical Test Method for the Primary Effectiveness Endpoint Superiority & \\begin{tabular}{l}\nA chi-square test will be used to test the two-sided hypothesis of superiority of the Lotus Valve versus CoreValve:\n\\[\n\\begin{aligned}\n& H_{0}: P_{E \\_ \\text {Lotus }}=P_{E \\_ \\text {Control }} \\\\\n& H_{1}: P_{E \\_ \\text {Lotus }} \\neq P_{E \\_ \\text {Control }}\n\\end{aligned}\n\\] \\\\\nwhere \\(P _{ E \\_ \\text {Lotus }}\\) and \\(P _{ E \\_ \\text {Control }}\\) correspond to the rates of the primary effectiveness endpoint for the Lotus Valve group (test) and the CoreValve group (control), respectively. \\\\\nThe primary analysis set for superiority test of the primary effectiveness endpoint is the ITT analysis set. This endpoint will also be analyzed for the as-treated and implanted analysis sets.\n\\end{tabular} \\\\\n\\hline Sample Size Parameters for the Primary Effectiveness Endpoint Superiority & \\begin{tabular}{l}\n- Expected Lotus Valve (test) rate \\(P _{ E \\_ \\text {Lotus }}=22 \\%\\) \\\\\n- Expected CoreValve (control) rate \\(P _{\\text {E_Control }}=32 \\%\\) \\\\\n- Test significance level \\((\\alpha)=0.05\\) ( 2 -sided) \\\\\n- Test : Control ratio = 2:1 \\\\\n- Power \\((1-\\beta)=80 \\%\\) \\\\\n- Total number of evaluable subjects \\(=684\\) \\\\\n- Expected rate of attrition \\(=10 \\%\\) \\\\\n- Given enrollment of 912 subjects ( 608 Lotus Valve, 304 CoreValve) and \\(10 \\%\\) attrition, there is approximately \\(86 \\%\\) power to show superiority with the given expected rates\n\\end{tabular} \\\\\n\\hline Success Criteria for the Primary Effectiveness Endpoint Superiority & If the \\(P\\) value from the chi-square test is \\(<0.05\\) and the rate of the Lotus Valve group is less than the rate of the CoreValve group, the rate of the primary effectiveness endpoint for the Lotus Valve will be concluded to be superior to the CoreValve rate. 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This endpoint will also be analyzed for the as-treated and implanted analysis sets.\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nA chi-square test will be used to test the two-sided hypothesis of superiority of the Lotus Valve versus CoreValve:\n\\[\n\\begin{aligned}\n& H_{0}: P_{E \\_ \\text {Lotus }}=P_{E \\_ \\text {Control }} \\\\\n& H_{1}: P_{E \\_ \\text {Lotus }} \\neq P_{E \\_ \\text {Control }}\n\\end{aligned}\n\\] \\\\\nwhere \\(P _{ E \\_ \\text {Lotus }}\\) and \\(P _{ E \\_ \\text {Control }}\\) correspond to the rates of the primary effectiveness endpoint for the Lotus Valve group (test) and the CoreValve group (control), respectively. \\\\\nThe primary analysis set for superiority test of the primary effectiveness endpoint is the ITT analysis set. 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Expected Lotus Valve (test) rate \\(P _{ E \\_ \\text {Lotus }}=22 \\%\\) \\\\\n- Expected CoreValve (control) rate \\(P _{\\text {E_Control }}=32 \\%\\) \\\\\n- Test significance level \\((\\alpha)=0.05\\) ( 2 -sided) \\\\\n- Test : Control ratio = 2:1 \\\\\n- Power \\((1-\\beta)=80 \\%\\) \\\\\n- Total number of evaluable subjects \\(=684\\) \\\\\n- Expected rate of attrition \\(=10 \\%\\) \\\\\n- Given enrollment of 912 subjects ( 608 Lotus Valve, 304 CoreValve) and \\(10 \\%\\) attrition, there is approximately \\(86 \\%\\) power to show superiority with the given expected rates\n\\end{tabular}","text_display":"\\begin{tabular}{l}\n- Expected Lotus Valve (test) rate \\(P _{ E \\_ \\text {Lotus }}=22 \\%\\) \\\\\n- Expected CoreValve (control) rate \\(P _{\\text {E_Control }}=32 \\%\\) \\\\\n- Test significance level \\((\\alpha)=0.05\\) ( 2 -sided) \\\\\n- Test : Control ratio = 2:1 \\\\\n- Power \\((1-\\beta)=80 \\%\\) \\\\\n- Total number of evaluable subjects \\(=684\\) \\\\\n- 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Randomized Clinical Evaluation} \\\\\n\\hline Statistical Test Method for the Secondary Endpoint & \\begin{tabular}{l}\nA chi-square test will be used to test the two-sided hypothesis of superiority:\n\\[\n\\begin{aligned}\n& H_{0}: P_{\\text {AR_Lotus }}=P_{\\text {AR_Control }} \\\\\n& H_{1}: P_{\\text {AR_Lotus }} \\neq P_{\\text {AR_Control }}\n\\end{aligned}\n\\] \\\\\nwhere \\(P _{\\text {AR_Lotus }}\\) and \\(P _{\\text {AR_Control }}\\) correspond to the moderate or greater paravalvular aortic regurgitation rates at 1 year for the Lotus Valve group (test) and the CoreValve group (control), respectively. \\\\\nThe primary analysis set for the secondary endpoint is the ITT analysis set. 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This endpoint will also be analyzed for the as-treated and implanted analysis sets.\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nA chi-square test will be used to test the two-sided hypothesis of superiority:\n\\[\n\\begin{aligned}\n& H_{0}: P_{\\text {AR_Lotus }}=P_{\\text {AR_Control }} \\\\\n& H_{1}: P_{\\text {AR_Lotus }} \\neq P_{\\text {AR_Control }}\n\\end{aligned}\n\\] \\\\\nwhere \\(P _{\\text {AR_Lotus }}\\) and \\(P _{\\text {AR_Control }}\\) correspond to the moderate or greater paravalvular aortic regurgitation rates at 1 year for the Lotus Valve group (test) and the CoreValve group (control), respectively. \\\\\nThe primary analysis set for the secondary endpoint is the ITT analysis set. This endpoint will also be analyzed for the as-treated and implanted analysis sets.\n\\end{tabular}","cell_row":1,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.9956073760986328,"confidence_rate":0.9999935319220733},{"cnt":[[605,535],[1694,535],[1694,584],[605,584]],"region":{"top_left_x":605,"top_left_y":534,"width":1089,"height":50},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2c8268943b45413fa2a578d0d54eb25f","type":"text","conversion_output":false,"parent_id":"fd1a4436e5ce4cdb9ecad83b82c88801","text":"A chi-square test will be used to test the two-sided hypothesis of","text_display":"A chi-square test will be used to test the two-sided hypothesis of","confidence":1,"confidence_rate":1},{"cnt":[[605,581],[801,581],[801,633],[605,633]],"region":{"top_left_x":605,"top_left_y":581,"width":197,"height":53},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7a90028011f54ec5a9943023c15f85df","type":"text","conversion_output":false,"parent_id":"fd1a4436e5ce4cdb9ecad83b82c88801","text":"superiority:","text_display":" superiority:","confidence":1,"confidence_rate":1},{"cnt":[[679,639],[1104,639],[1104,750],[679,750]],"region":{"top_left_x":678,"top_left_y":638,"width":427,"height":113},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"064492a82c0d440e9caf41c5608188ba","type":"math","conversion_output":false,"parent_id":"fd1a4436e5ce4cdb9ecad83b82c88801","text":"\\[\n\\begin{aligned}\n& H_{0}: P_{\\text {AR_Lotus }}=P_{\\text {AR_Control }} \\\\\n& H_{1}: P_{\\text {AR_Lotus }} \\neq P_{\\text {AR_Control }}\n\\end{aligned}\n\\]","text_display":"\n\\[\n\\begin{aligned}\n& H_{0}: P_{\\text {AR_Lotus }}=P_{\\text {AR_Control }} \\\\\n& H_{1}: P_{\\text {AR_Lotus }} \\neq P_{\\text {AR_Control }}\n\\end{aligned}\n\\]","confidence":0.9956073760986328,"confidence_rate":0.9999683292798066},{"cnt":[[605,756],[1743,756],[1743,808],[605,808]],"region":{"top_left_x":605,"top_left_y":755,"width":1138,"height":53},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1df3016cbb46460fbf2b06e157d20e06","type":"text","conversion_output":false,"parent_id":"fd1a4436e5ce4cdb9ecad83b82c88801","text":"where \\(P _{\\text {AR_Lotus }}\\) and \\(P _{\\text {AR_Control }}\\) correspond to the moderate or greater","text_display":"\nwhere \\(P _{\\text {AR_Lotus }}\\) and \\(P _{\\text {AR_Control }}\\) correspond to the moderate or greater","confidence":0.9990236759185791,"confidence_rate":0.9999911200303706},{"cnt":[[605,805],[1838,805],[1838,857],[605,857]],"region":{"top_left_x":605,"top_left_y":804,"width":1234,"height":53},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"afb185fe5ed8465bab30092c10302139","type":"text","conversion_output":false,"parent_id":"fd1a4436e5ce4cdb9ecad83b82c88801","text":"paravalvular aortic regurgitation rates at 1 year for the Lotus Valve group","text_display":" paravalvular aortic regurgitation rates at 1 year for the Lotus Valve group","confidence":0.99853515625,"confidence_rate":0.9999823384971409},{"cnt":[[605,854],[1514,854],[1514,903],[605,903]],"region":{"top_left_x":605,"top_left_y":854,"width":909,"height":50},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cbcb078bf24f4048879dcce7edcd3c00","type":"text","conversion_output":false,"parent_id":"fd1a4436e5ce4cdb9ecad83b82c88801","text":"(test) and the CoreValve group (control), respectively.","text_display":" (test) and the CoreValve group (control), respectively.","confidence":1,"confidence_rate":1},{"cnt":[[605,920],[1860,920],[1860,971],[605,971]],"region":{"top_left_x":605,"top_left_y":919,"width":1256,"height":53},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c9cf042d7ed84e04b5fc4d59a4d81103","type":"text","conversion_output":false,"parent_id":"fd1a4436e5ce4cdb9ecad83b82c88801","text":"The primary analysis set for the secondary endpoint is the ITT analysis set.","text_display":"\nThe primary analysis set for the secondary endpoint is the ITT analysis set.","confidence":1,"confidence_rate":1},{"cnt":[[605,969],[1743,969],[1743,1021],[605,1021]],"region":{"top_left_x":605,"top_left_y":968,"width":1138,"height":53},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f393a2fe829e4af7bb97d66a9303acba","type":"text","conversion_output":false,"parent_id":"fd1a4436e5ce4cdb9ecad83b82c88801","text":"This endpoint will also be analyzed for the as-treated and implanted","text_display":" This endpoint will also be analyzed for the as-treated and implanted","confidence":1,"confidence_rate":1},{"cnt":[[605,1018],[826,1018],[826,1067],[605,1067]],"region":{"top_left_x":605,"top_left_y":1017,"width":222,"height":50},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"eb50a89af6ce45daa0211f3054db0874","type":"text","conversion_output":false,"parent_id":"fd1a4436e5ce4cdb9ecad83b82c88801","text":"analysis sets.","text_display":" analysis 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Endpoint","cell_row":2,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[310,1116],[531,1116],[531,1162],[310,1162]],"region":{"top_left_x":310,"top_left_y":1116,"width":222,"height":47},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3bce0af1a9ed42ce8e1e23024e745daf","type":"text","conversion_output":false,"parent_id":"6f08984e2ce4429d977834bfde2d9904","text":"Sample Size","text_display":"Sample Size","confidence":1,"confidence_rate":1},{"cnt":[[310,1165],[520,1165],[520,1203],[310,1203]],"region":{"top_left_x":310,"top_left_y":1165,"width":211,"height":39},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d5bd33b965bc4d38898c956547a95c14","type":"text","conversion_output":false,"parent_id":"6f08984e2ce4429d977834bfde2d9904","text":"Parameters","text_display":" Parameters","confidence":1,"confidence_rate":1},{"cnt":[[310,1209],[436,1209],[436,1250],[310,1250]],"region":{"top_left_x":310,"top_left_y":1208,"width":126,"height":42},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a0bf6676961f48ad894bc6d6d6a39c27","type":"text","conversion_output":false,"parent_id":"6f08984e2ce4429d977834bfde2d9904","text":"for the","text_display":" for the","confidence":1,"confidence_rate":1},{"cnt":[[310,1258],[504,1258],[504,1307],[310,1307]],"region":{"top_left_x":310,"top_left_y":1257,"width":195,"height":51},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"210bb445399a4e08aea038a3e7e47520","type":"text","conversion_output":false,"parent_id":"6f08984e2ce4429d977834bfde2d9904","text":"Secondary","text_display":" Secondary","confidence":1,"confidence_rate":1},{"cnt":[[310,1307],[482,1307],[482,1353],[310,1353]],"region":{"top_left_x":310,"top_left_y":1307,"width":173,"height":47},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7ccb43ac98f74dc28c961411434c228c","type":"text","conversion_output":false,"parent_id":"6f08984e2ce4429d977834bfde2d9904","text":"Endpoint","text_display":" Endpoint","confidence":1,"confidence_rate":1},{"cnt":[[600,1108],[1879,1108],[1879,1555],[600,1555]],"region":{"top_left_x":599,"top_left_y":1107,"width":1281,"height":449},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4371478cb988405986dc618d3f925f4a","type":"complex_cell","conversion_output":false,"parent_id":"5c00dd17a1f040a19a9b98733ef73531","children_ids":["815b0271ce65441480c0a60fac5a5938","89ae109f9fca4823868742d833070a2d","953671d478bc499eb15a85c643920235","d8cbd740f8ff492f9ab063c16b443311","8a9a34af50f24a6a8983048f0556bbd0","5fd5c444acde4185a2f38e8a9547f49a","808aa07ced61483aaaea6e6ff22f08a6","fedb2ee789a04b438fbbc9c3982a8827"],"text":"\\begin{tabular}{l}\n- Expected Lotus Valve (test) rate \\(P _{\\text {AR_Lotus }}=1.1 \\%\\) \\\\\n- Expected CoreValve (control) rate \\(P _{\\text {AR_Control }}=5.3 \\%\\) \\\\\n- Test significance level \\((\\alpha)=0.05\\) ( 2 -sided) \\\\\n- Test : Control ratio = 2:1 \\\\\n- Expected rate of attrition \\(=25 \\%\\) \\\\\n- Given enrollment of 912 subjects ( 608 Lotus Valve, 304 CoreValve) and \\(25 \\%\\) attrition, there is approximately \\(86 \\%\\) power to show superiority with the given expected rates\n\\end{tabular}","text_display":"\\begin{tabular}{l}\n- Expected Lotus Valve (test) rate \\(P _{\\text {AR_Lotus }}=1.1 \\%\\) \\\\\n- Expected CoreValve (control) rate \\(P _{\\text {AR_Control }}=5.3 \\%\\) \\\\\n- Test significance level \\((\\alpha)=0.05\\) ( 2 -sided) \\\\\n- Test : Control ratio = 2:1 \\\\\n- Expected rate of attrition \\(=25 \\%\\) \\\\\n- Given enrollment of 912 subjects ( 608 Lotus Valve, 304 CoreValve) and \\(25 \\%\\) attrition, there is approximately \\(86 \\%\\) power to show superiority with the given expected 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The Lotus Valve System and","text_display":" Heart a Division of Boston Scientific Corporation (BSC). The Lotus Valve System and","confidence":1,"confidence_rate":1},{"cnt":[[309,657],[1768,657],[1768,707],[309,707]],"region":{"top_left_x":309,"top_left_y":657,"width":1460,"height":50},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6b85aff92fd3425089e0a14e5bdc67d3","type":"text","conversion_output":true,"text":"LOTUS Edge \\({ }^{\\text {TM }}\\) Valve System both consist of a pre-loaded, stent-mounted tissue valve","text_display":" LOTUS Edge \\({ }^{\\text {TM }}\\) Valve System both consist of a pre-loaded, stent-mounted tissue valve","confidence":0.97412109375,"confidence_rate":0.9997454726224891},{"cnt":[[309,705],[1867,705],[1867,754],[309,754]],"region":{"top_left_x":309,"top_left_y":704,"width":1558,"height":51},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"77b7d43b68f24cb99315730f5949ee84","type":"text","conversion_output":true,"text":"prosthesis and catheter delivery system designed to enable predictable and precise placement","text_display":" prosthesis and catheter delivery system designed to enable predictable and precise placement","confidence":1,"confidence_rate":1},{"cnt":[[309,752],[1800,752],[1800,801],[309,801]],"region":{"top_left_x":309,"top_left_y":751,"width":1492,"height":51},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b9a89b5540d34089a1fe8ecaa58d47b7","type":"text","conversion_output":true,"text":"of the valve during transcatheter aortic valve replacement (TAVR). Early leaflet function","text_display":" of the valve during transcatheter aortic valve replacement (TAVR). 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If needed, the valve may be partially","text_display":" frame facilitate optimal initial positioning of the valve. 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The valve also has a polycarbonate-based","confidence":1,"confidence_rate":1},{"cnt":[[309,993],[1678,993],[1678,1040],[309,1040]],"region":{"top_left_x":309,"top_left_y":992,"width":1369,"height":48},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cab778cdc8f94f04bf1eab33e590da32","type":"text","conversion_output":true,"text":"urethane outer seal (Adaptive Seal \\({ }^{\\text {TM }}\\) ) designed to minimize paravalvular leakage.","text_display":" urethane outer seal (Adaptive Seal \\({ }^{\\text {TM }}\\) ) designed to minimize paravalvular leakage.","confidence":0.9897723197937012,"confidence_rate":0.9998992174092073},{"cnt":[[309,1040],[1745,1040],[1745,1089],[309,1089]],"region":{"top_left_x":309,"top_left_y":1039,"width":1436,"height":51},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ba94c39d0fed4b7f8ab8ca91bd3cb76f","type":"text","conversion_output":true,"text":"Additionally, the LOTUS Edge valve has tantalum (radiopaque) markers on the valve","text_display":" Additionally, the LOTUS Edge valve has tantalum (radiopaque) markers on the valve","confidence":1,"confidence_rate":1},{"cnt":[[309,1087],[1807,1087],[1807,1137],[309,1137]],"region":{"top_left_x":309,"top_left_y":1087,"width":1498,"height":50},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ccc861bcb2aa45c0979aa7c47e748edb","type":"text","conversion_output":true,"text":"locking assembly (i.e., buckle and post-top components) to aid in visualization of locking","text_display":" locking assembly (i.e., buckle and post-top components) to aid in visualization of locking","confidence":1,"confidence_rate":1},{"cnt":[[309,1134],[1807,1134],[1807,1184],[309,1184]],"region":{"top_left_x":309,"top_left_y":1134,"width":1498,"height":50},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2e5c82c3d6f64686be1964e38570e730","type":"text","conversion_output":true,"text":"during the procedure and a catheter delivery system designed for improved deliverability.","text_display":" during the procedure and a catheter delivery system designed for improved deliverability.","confidence":1,"confidence_rate":1},{"cnt":[[309,1182],[1807,1182],[1807,1231],[309,1231]],"region":{"top_left_x":309,"top_left_y":1181,"width":1498,"height":51},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c0bfd2d66681418e8ddf4f4477be3a8e","type":"text","conversion_output":true,"text":"More detailed description of the devices can be found in Section 5 and in the Investigator","text_display":" More detailed description of the devices can be found in Section 5 and in the Investigator","confidence":1,"confidence_rate":1},{"cnt":[[309,1231],[1867,1231],[1867,1280],[309,1280]],"region":{"top_left_x":309,"top_left_y":1231,"width":1558,"height":50},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ceb59e4f71514256b77c2da0a3dd2c97","type":"text","conversion_output":true,"text":"Brochure. 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Aortic stenosis is associated with high rates of death and complications","confidence":1,"confidence_rate":1},{"cnt":[[305,2166],[922,2166],[922,2219],[305,2219]],"region":{"top_left_x":305,"top_left_y":2165,"width":617,"height":55},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"149dd5d2cfd744829018638c102a08d1","type":"text","conversion_output":true,"text":"after the appearance of symptoms \\({ }^{7,8}\\).","text_display":" after the appearance of symptoms \\({ }^{7,8}\\).","confidence":1,"confidence_rate":1},{"cnt":[[307,2239],[1798,2239],[1798,2288],[307,2288]],"region":{"top_left_x":307,"top_left_y":2238,"width":1492,"height":51},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"aa8b9368e3864e2e8785b311e0e1a6ca","type":"text","conversion_output":true,"text":"The standard of care for AS in patients who do not have serious comorbidities is surgical","text_display":"\n\nThe standard of care for AS in patients who do not have serious comorbidities is surgical","confidence":1,"confidence_rate":1},{"cnt":[[305,2288],[1837,2288],[1837,2335],[305,2335]],"region":{"top_left_x":305,"top_left_y":2288,"width":1532,"height":48},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"df25eed7f4614ec9ae06e99efa712e00","type":"text","conversion_output":true,"text":"aortic valve replacement (SAVR), which has been shown to reduce symptoms and improve","text_display":" aortic valve replacement (SAVR), which has been shown to reduce symptoms and improve","confidence":0.99951171875,"confidence_rate":0.9999945123690109},{"cnt":[[305,2329],[1833,2329],[1833,2383],[305,2383]],"region":{"top_left_x":305,"top_left_y":2328,"width":1528,"height":55},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"30e3841453f749cb8705cac8a3ed3ecc","type":"text","conversion_output":true,"text":"survival \\({ }^{5,7,9-11}\\). Between 1999 and 2011, the rate of surgical AVR for elderly subjects in the","text_display":" survival \\({ }^{5,7,9-11}\\). Between 1999 and 2011, the rate of surgical AVR for elderly subjects in the","confidence":0.99951171875,"confidence_rate":0.9999956778810385},{"cnt":[[307,2376],[1794,2376],[1794,2432],[307,2432]],"region":{"top_left_x":307,"top_left_y":2376,"width":1487,"height":57},"line":48,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"334bb1a6b4e9463cb5fdd383b4aa6fa7","type":"text","conversion_output":true,"text":"United States has increased and outcomes have improved \\({ }^{11}\\). However, up to one-third of","text_display":" United States has increased and outcomes have improved \\({ }^{11}\\). However, up to one-third of","confidence":1,"confidence_rate":1},{"cnt":[[305,2432],[1749,2432],[1749,2481],[305,2481]],"region":{"top_left_x":305,"top_left_y":2432,"width":1444,"height":50},"line":49,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"679b6a7ff035445f9f309e9b335a763d","type":"text","conversion_output":true,"text":"patients with severe AS are not treated with SAVR because of their comorbidities and","text_display":" patients with severe AS are not treated with SAVR because of their comorbidities and","confidence":1,"confidence_rate":1},{"cnt":[[103,2651],[312,2651],[312,2690],[103,2690]],"region":{"top_left_x":103,"top_left_y":2651,"width":209,"height":39},"line":50,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"49e1bdbadf444f45b0e2a9522f56d03d","type":"page_info","conversion_output":false,"text":"Released","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[829,2655],[1291,2655],[1291,2690],[829,2690]],"region":{"top_left_x":829,"top_left_y":2655,"width":463,"height":35},"line":51,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9687f37308014ff9a47ef89460757db0","type":"page_info","conversion_output":false,"text":"REPRISE III Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1654,2653],[1983,2653],[1983,2688],[1654,2688]],"region":{"top_left_x":1654,"top_left_y":2653,"width":330,"height":35},"line":52,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"febbd2bde69a4cd8ba0608caa57894da","type":"page_info","conversion_output":false,"text":"90899936 AK. 4","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[486,2690],[2000,2690],[2000,2735],[486,2735]],"region":{"top_left_x":485,"top_left_y":2689,"width":1516,"height":46},"line":53,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b5fafc236cb54bccaa44287843bb1d62","type":"page_info","conversion_output":false,"text":"Boston Scientific Confidential. 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Percutaneous transluminal aortic valvuloplasty, which was introduced as an","text_display":" \\(50 \\%^{13-15}\\). Percutaneous transluminal aortic valvuloplasty, which was introduced as an","confidence":0.9853515625,"confidence_rate":0.9998462953008003},{"cnt":[[305,509],[1835,509],[1835,561],[305,561]],"region":{"top_left_x":305,"top_left_y":509,"width":1530,"height":52},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"991846c592984392be2d0d32ab4aba51","type":"text","conversion_output":true,"text":"alternative to SAVR in elderly and/or high-surgical-risk subjects, can provide symptomatic","text_display":" alternative to SAVR in elderly and/or high-surgical-risk subjects, can provide symptomatic","confidence":1,"confidence_rate":1},{"cnt":[[305,559],[1811,559],[1811,608],[305,608]],"region":{"top_left_x":305,"top_left_y":558,"width":1507,"height":51},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a4014f0da3264a019d7fb937b8872d0d","type":"text","conversion_output":true,"text":"relief and/or temporary improvement but does not provide definitive treatment in subjects","text_display":" relief and/or temporary improvement but does not provide definitive treatment in subjects","confidence":0.99951171875,"confidence_rate":0.999994804263518},{"cnt":[[305,606],[1848,606],[1848,655],[305,655]],"region":{"top_left_x":305,"top_left_y":605,"width":1543,"height":51},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3b233ebc1bdd4c618d2ea2a5d7125471","type":"text","conversion_output":true,"text":"with severe calcific AS. It is also associated with relatively high mortality and complication","text_display":" with severe calcific AS. It is also associated with relatively high mortality and complication","confidence":0.99951171875,"confidence_rate":0.9999950666738041},{"cnt":[[305,649],[432,649],[432,698],[305,698]],"region":{"top_left_x":305,"top_left_y":648,"width":127,"height":51},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c43d4319dac74fb0af44b540831d85bc","type":"text","conversion_output":true,"text":"rates \\({ }^{16}\\).","text_display":" rates \\({ }^{16}\\).","confidence":1,"confidence_rate":1},{"cnt":[[305,724],[1777,724],[1777,771],[305,771]],"region":{"top_left_x":305,"top_left_y":724,"width":1472,"height":48},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"072196c9d8244877b3475154d15fffe8","type":"text","conversion_output":true,"text":"Transcatheter aortic valve replacement (TAVR) has recently emerged as a less invasive","text_display":"\n\nTranscatheter aortic valve replacement (TAVR) has recently emerged as a less invasive","confidence":1,"confidence_rate":1},{"cnt":[[305,765],[1858,765],[1858,819],[305,819]],"region":{"top_left_x":305,"top_left_y":764,"width":1554,"height":55},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"11d49bfdf1e64fb69042600395681594","type":"text","conversion_output":true,"text":"treatment strategy in subjects who are not suitable candidates for open-heart surgery \\({ }^{17-21}\\) and","text_display":" treatment strategy in subjects who are not suitable candidates for open-heart surgery \\({ }^{17-21}\\) and","confidence":1,"confidence_rate":1},{"cnt":[[305,812],[1803,812],[1803,868],[305,868]],"region":{"top_left_x":305,"top_left_y":812,"width":1498,"height":56},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"209daacb819a43f4ad12b939a4d5bafa","type":"text","conversion_output":true,"text":"more than 60,000 transcatheter aortic valve prostheses have been implanted worldwide \\({ }^{22}\\).","text_display":" more than 60,000 transcatheter aortic valve prostheses have been implanted worldwide \\({ }^{22}\\).","confidence":0.9980475902557373,"confidence_rate":0.9999817355109043},{"cnt":[[305,868],[1757,868],[1757,917],[305,917]],"region":{"top_left_x":305,"top_left_y":867,"width":1453,"height":51},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"eb9432572e494cb9b9484cb719cb4d87","type":"text","conversion_output":true,"text":"Patients with severe aortic stenosis undergo a joint interdisciplinary screening process,","text_display":" Patients with severe aortic stenosis undergo a joint interdisciplinary screening process,","confidence":1,"confidence_rate":1},{"cnt":[[305,907],[1815,907],[1815,965],[305,965]],"region":{"top_left_x":305,"top_left_y":906,"width":1511,"height":59},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9ebbdb4fb91a4c13baf13cc316f36315","type":"text","conversion_output":true,"text":"including comprehensive multimodality imaging \\({ }^{23-26}\\), prior to procedure recommendation.","text_display":" including comprehensive multimodality imaging \\({ }^{23-26}\\), prior to procedure recommendation.","confidence":1,"confidence_rate":1},{"cnt":[[305,954],[1826,954],[1826,1012],[305,1012]],"region":{"top_left_x":305,"top_left_y":953,"width":1522,"height":59},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"44158004678b46eca12f98e6317485ed","type":"text","conversion_output":true,"text":"Because existing surgical risk scores imperfectly characterize risk \\({ }^{27-30}\\), center Heart Teams","text_display":" Because existing surgical risk scores imperfectly characterize risk \\({ }^{27-30}\\), center Heart Teams","confidence":1,"confidence_rate":1},{"cnt":[[305,1010],[1841,1010],[1841,1061],[305,1061]],"region":{"top_left_x":305,"top_left_y":1009,"width":1537,"height":53},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e69dc4e0c3dc4b30896446d87fc6c17f","type":"text","conversion_output":true,"text":"also consider other co-morbidities and patient frailty. While not captured well by any of the","text_display":" also consider other co-morbidities and patient frailty. While not captured well by any of the","confidence":1,"confidence_rate":1},{"cnt":[[305,1057],[1704,1057],[1704,1106],[305,1106]],"region":{"top_left_x":305,"top_left_y":1057,"width":1399,"height":50},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"85779ece1c414e0a9e751d27c8b2e5d4","type":"text","conversion_output":true,"text":"standard risk scores, these added measures help to more fully characterize a patient","text_display":" standard risk scores, these added measures help to more fully characterize a patient","confidence":1,"confidence_rate":1},{"cnt":[[305,1100],[1154,1100],[1154,1158],[305,1158]],"region":{"top_left_x":305,"top_left_y":1100,"width":849,"height":59},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ed14704ab82c4991b09b8ec362b0440c","type":"text","conversion_output":true,"text":"population that potentially benefits from TAVR \\({ }^{31}\\).","text_display":" population that potentially benefits from TAVR \\({ }^{31}\\).","confidence":1,"confidence_rate":1},{"cnt":[[305,1173],[1712,1173],[1712,1227],[305,1227]],"region":{"top_left_x":305,"top_left_y":1173,"width":1408,"height":54},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"438f32b69160468b9fc8749562557872","type":"text","conversion_output":true,"text":"Transcatheter aortic valve replacement was initially performed through a retrograde","text_display":"\nTranscatheter aortic valve replacement was initially performed through a retrograde","confidence":1,"confidence_rate":1},{"cnt":[[305,1222],[1794,1222],[1794,1274],[305,1274]],"region":{"top_left_x":305,"top_left_y":1222,"width":1489,"height":53},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cb0748c51c1c4c1bb6137e9d394682db","type":"text","conversion_output":true,"text":"transfemoral approach and an antegrade transapical approach. Two additional retrograde","text_display":" transfemoral approach and an antegrade transapical approach. Two additional retrograde","confidence":1,"confidence_rate":1},{"cnt":[[305,1268],[1858,1268],[1858,1321],[305,1321]],"region":{"top_left_x":305,"top_left_y":1267,"width":1554,"height":55},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d093f8ee24634fec9f99ce02ffa63f74","type":"text","conversion_output":true,"text":"approaches, transaortic through the ascending aorta and trans-subclavian, were subsequently","text_display":" approaches, transaortic through the ascending aorta and trans-subclavian, were subsequently","confidence":1,"confidence_rate":1},{"cnt":[[305,1311],[1858,1311],[1858,1369],[305,1369]],"region":{"top_left_x":305,"top_left_y":1310,"width":1554,"height":59},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"afec2bd7720b4fe0a659f0615c88de3e","type":"text","conversion_output":true,"text":"described \\({ }^{19,32}\\). Evidence of the safety of the procedure using either a balloon expandable or a","text_display":" described \\({ }^{19,32}\\). 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In the randomized","text_display":" studies \\({ }^{33-39}\\), device-specific registries \\({ }^{40-54}\\), and national registries \\({ }^{55-62}\\). 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In the randomized U.S.","text_display":" either TAVR or surgical replacement had a similar mortality risk \\({ }^{64,65}\\). 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A more detailed summary of","text_display":" Risk Pivotal Trial, and the U.S. CoreValve High Risk Study. A more detailed summary of","confidence":1,"confidence_rate":1},{"cnt":[[305,675],[1386,675],[1386,724],[305,724]],"region":{"top_left_x":305,"top_left_y":674,"width":1081,"height":51},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0f21cdba407247dba0f89141f7a3978f","type":"text","conversion_output":true,"text":"the available literature is presented in the Investigator Brochure.","text_display":" the available literature is presented in the Investigator Brochure.","confidence":1,"confidence_rate":1},{"cnt":[[391,752],[1792,752],[1792,806],[391,806]],"region":{"top_left_x":391,"top_left_y":751,"width":1401,"height":55},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a5d7a1cf5f344793a38002e3031e6a4a","type":"figure_label","conversion_output":false,"text":"Table 4.1-1: Events from Peri-Operative to 30 Days (Transfemoral Approach)","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999940439141021},{"cnt":[[288,804],[1899,804],[1899,2475],[288,2475]],"region":{"top_left_x":287,"top_left_y":803,"width":1613,"height":1672},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5f3b167d7aa046b6a45274316e7e6679","type":"table","conversion_output":true,"children_ids":["343fafc1dca741c686b3bb126a5763a9","61f9db6206424a5c9ed8b0244852b706","c2872a7af3cc48faa72e5b343b3410df","591f8e5caca244c18b0852f9e3378ff8","6c967b3643d64aaca5e1976dbbe017f1","18fb842bf825465a9387525be8c3031c","e3a97caf57774880ad55f1dfdb99390e","3d9e773c1cd549379108887524799ea2","e6f696935e6a4b4980f7ae37118b4631","8dd5dddccaff471b869f7cd0458bfbc1","60c8578d840c4694b95f6f8562cd28ff","6dc8080b6ee7495f85c541a9b063597e","e1c523c4b1634bee856323391e6546af","00ae6eea3916440c9cc18e8220b5ced8","b558b167c90c4952aabcfe0cb17e90fb","9657a64b1ea845cf893704d8245ad00d","6dedb97767ce40febf10a38e27d3d60b","1ab2f7f680c2428198d7385dfd4cfc8d","1ee6015932c64d8297ccf9af95912433","232bd9d16e044d91ab0b6ce50a455af3","631a64bfe8844bc7bd5ebb02d662ad24","300e758185fa45c48b3ca89e191cad99","0cf54e45a8c24435b381f87ab5aa7869","b47bdf63f8a44f2cbc78e8c1e3adda33","968c2c09743e4793bbf6c5259b3486a0","54abeb1f4439499a979fe38759d6944b","1092c73b5efc4787a117354c8c1886b9","cf21397773fb490d9e339608febe6c41","33ed39b15a684ba1aaabbda9eb0ebdaa","b6024b191baf4db4a42f2dbde4cdc549","8caa28dfcc354c819c578086bd76b28a","ea1052b4477547ff8727f365c50d02c4","b5d1f38f969c437f886de01413fef754","50ffb8cc9ace494aa62cc4cbee733d98","7fcfa975f7694888977560ff6983d6e7","67fde2609167431e9cc1ef80933df5e1","680374f3ad7b4b6e935fc17fc697dc14","93968adef7084b48acff10c7326f1aa7","e1d222a2847b49be87f6dbc8181cc5d4","fcf718aac06e4e49b29dd5cf6f742f46","666c166d7ff54bd4880a9f77afde6890","308a9b5a4fc34f64a96b3ae76cec33d8","406e1b2346f3414f83d572373f5eedc2","4b95a34fe186404fa0f985e562a2dadb","d08f20b03e2c49e8b1734482c6389e46","d947413ad36c4223bf2c0a8b9821a286","f1c897344aea4cd19fe128a02b124b88","6110a3b5e7614e23be259d428363c4a5","f2373b33581348109ecf68f2699b8fc4","40e8ab4978fa46e28864c06a545dfab9","a5612e8a658749bea7be1a1c3c3d9ae1","481ed86af4414d48b556ced22df5f6d0","bc6a3ade337b49dbba2eb4d2a3f28768","2d66aee8cc2c4646b63790541b9c8ee3","a744cc327d874d95be61cda9b9a309be","3812dcc71ee94313a88e4fde7578df44","da625b731e614116975eb1e163a3aa66","d68a62a5a9784e37a3bd83b1e553e674","52375ec0e5be4157902151e5e06f178f","5424ce401f404f16a07798383a2d5d1e","c5b693da70b445899afe1663e897912d","dc1651475ebc4f54ad46d8811bff4d30","e99b6d72fedc44e29b0c00c2c5e6b9d2","4f24fe82f0cd467094e2c52803b63ebc","328e4656036e42bc94a6d63015ae6c14","b264fe4548b54b5bbf2cb8f709cd05ac","983b65f8d5f34af192a9e5874bad17c7","76cd1d9f9b7343a6a18010d8e9f2fd7e","1cea72cd8813414ea8a29ab63740f13a","acaa08c43dc947f39952f64ed8cf1b5a","819e877c85404ad7b624bae220a183a9","4c6cf5504a834cb3864923bc0573dfee","4e10a61dd5204f2bbbfe0427a0d039be","e1147006eb60441397e18ccaf57ad8d3","d71f572024a64d23bdd4aeaf1fb80eb0","a054da58b2324f2780d7e703cbe74d9f","1ef2ed8cbb884d769598d2e4f5fb9d26","cd4c8d5ac7cd4d2aab3b780fdb2426b7","089a567f0d534fb5b778f32aff02a77b","8b7955aae59f4662bf522f0b025d2ca8","cd657103a0d247a083553e40e0c8df70","10a86b31cd25454d8bf06c9835bbbec0","f789342f41cb4cdc8d0a7bd4cdfff5ec","10a5e03632654fc793d0fc88ed9ea365","82b33af6cf264e9280fa377b7b2336fd","934a7cce967b4b2cb853ae5b2c8400a1","353c5caddcda4edfafd89f545e62e50b","1fab19b4970446378bce769d4ed611c6","071906f614eb4cc4974b2bb086725708","63e78129d83447ab8430c6a8c40b4b6f","d3948b2f96464bbc89ec436ee66b5d29","a1a9a828c5ef40779964496359255735","8963dfc5f09d4989a1503093bd658974","11be016f52bd4e2e9dc8f261466bf928","e472a297c334492583a02a595d22a845","f4fa953454654d3b93fdd536203ce8b7","ecd24d20bef349018caf7456d97f4a02","b49d069eaaa545b3a043b99276625932","ef0d377bfc0e4677998b3b5c2db94c71","9b70635e16be4dc3b4487d55bc16de64","6649a590686d4dc695a9aa442b3fe82e","98ef98cc674746d1bcd68e88c09d1780","eaafb26c6eb64ccab17cf98dd3b1fd79","d48c5930453643e388fa9d002dff6cdd","6b8af489bb214fcca7890d8c35234c52","8ad9115b68fd49bfacd82e2dd5f17df5","814f10e4388b4341b81997b02cd859d7","b006376615794550b7a7fe22a4b3c545","e4d66d4782c34894a4fec263900b1396","c44a0592850440b2ba9af1ac8c617274","97cb5b8e3dd14950b5edd785b6137a57","2eda94c54327411da217bf6bd8e3704d","2f9b0d5d215046bfaad79cab08619608","f29a6d1006284c538fa3391af55f76c0","71ded8a10fb842368c132576adcc1db3","faa3f629001c40c2bb890cfc8d541d7e","b2a144a4ba1545e588cff0c0f3927914","b9c99ead8d1341f28c9782906b8191d6","aa02a91da3d84f7d87dc6a9f2f8bef80","934a3731fa8349dd98a960896a887e83","a3f5c73c47574661986ceca75e7bd4cf","932bfc09e0884b00ba4ab22e04bfbdd4","704ccbc2f108401bbbbbbace2a2218fd","6ba09d9d487d42eca1cd05ac3eb6b0da","40dc3fc404b94eed89b15c38f8ae7f97","2af36407c1c5451783d17263351b069e","15c6de826eaf4dce9815c1945ce97c52","34dcf1b6965541bc921d8cf1ccdc9106","6345156945434318b3e08a3095bb467c","926da2b8502c40d08ef4e6ccbfe7ad78","ebd9495388664575bdb49f60f12d82a3","ff1cfa8815c0451fb26aea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Study & Device/N & Death (\\%) & MI (\\%) & Stroke* (\\%) & Bleeding (\\%) & AKI (\\%) & VC (\\%) \\\\\n\\hline Webb, et al. \\(2009^{33}\\) & \\(EW / 113{ }^{ a }\\) & 8 & N/A & 5.3 & 11.6 & 4.4 & 8 \\\\\n\\hline Rodés-Cabau, et al. \\(2010^{41}\\) & \\(EW / 168{ }^{ a }\\) & 9.5 & 0.6 & 3.0 & N/A & N/A & N/A \\\\\n\\hline Thomas, et al. \\(2010^{42}\\) & EW/463 \\({ }^{\\text {a }}\\) & 6.3 & N/A & 2.4 & 9.9 & 1.3 & 22.9 \\\\\n\\hline Leon, et al. \\(2010^{14}\\) & EW/267 \\({ }^{\\text {b }}\\) & 5 & 0 & 5 & 16.8 & 1.1 & \\(16.2{ }^{\\text {c }}\\) 30.7 \\\\\n\\hline Smith, et al. \\(2011{ }^{64}\\) & \\(EW / 244^{ a , d }\\) & 3.4 & 0 & 3.8 & 9.3 & 2.9 & \\(14{ }^{\\text {c }}\\) 22.7 \\\\\n\\hline Piazza, et al. \\(2008^{40}\\) & CV/646 & 8 & 0.6 & \\(1.9{ }^{\\text {e }}\\) & N/A & N/A & 1.2 \\\\\n\\hline Munoz-Garcia, et al. \\(2012{ }^{74}\\) & CV/133 \\({ }^{\\text {f }}\\) & 4.5 & 0.8 & 1.5 & N/A & N/A & \\(2.2^{ c }\\) \\\\\n\\hline Buchanan, et al. \\(2011{ }^{35}\\) & CV, EW/305 & 4.7 & 1.3 & 1.0 & 33.1 & \\(10.2^{ g }\\) & \\(15.7^{ c }\\) \\\\\n\\hline Moat, et al. \\(2011{ }^{57}\\) & CV, EW/599 & 5.5 & 1.0 & \\(4.0{ }^{\\text {h }}\\) & N/A & N/A & 6.2 \\\\\n\\hline Zahn, et al. \\(2011{ }^{56}\\) & CV, EW \\(/ 697{ }^{ i }\\) & 12.4 & 0.3 & \\(2.8{ }^{\\text {e }}\\) & N/A & N/A & \\(17.1{ }^{ j }\\) \\\\\n\\hline Bosmans, et al. \\(2011{ }^{58}\\) & CV/133 \\({ }^{\\text {a }}\\) EW/99 \\({ }^{\\text {a }}\\) & 8 CV ; 6 EW & N/A & \\(5^{ e , k }\\) & N/A & \\(6^{ k , 1}\\) & N/A \\\\\n\\hline Tamburino, et al. \\(2012{ }^{36}\\) & CV, EW/218 \\({ }^{\\text {m }}\\) & 6.9 & 0.0 & 2.3 & 5.5 & N/A & N/A \\\\\n\\hline Gilard, et al. \\(2012{ }^{59}\\) & CV, EW/2361 \\({ }^{\\text {a }}\\) & 8.5 & 0.8 & 2.2 & \\(1.2^{ n }\\) & N/A & \\(5.5^{ c }\\) \\\\\n\\hline Spargias, et al. \\(2013{ }^{60}\\) & CV/67, EW/59 & 1.0 & N/A & \\(0.0{ }^{\\text {e }}\\) & \\(2.0^{ c }\\) & N/A & \\(9.0^{\\circ}\\) \\\\\n\\hline Mack, et al. \\(2013{ }^{62}\\) & EW/3833 \\({ }^{\\text {a,d,h }} EW / 1139^{ a , b , h }\\) EW/1687 \\({ }^{\\text {a,d }}\\) EW/489 \\({ }^{ a , b }\\) & \\(3.8^{ a , d , h } 5.4^{ a , b , h } 5.0{ }^{ a , d } 6.7{ }^{ a , b }\\) & \\(0.5^{ a , d , h } 0.8^{ a , b , h } N / A ^{ a , b , d }\\) & \\(3.8{ }^{\\text {a,d,e,h }} 5.4^{ a , b , e , h } 3.2^{ a , d , e } 1.6^{ a , b , e }\\) & \\(3.2{ }^{ a , c , d , h } 3.6^{ a , b , c , h } N / A ^{ a , b , d }\\) & \\(1.3^{ a , d , h , l } 1.7^{ a , b , h , l } 1.5^{ a , d , l } 1.6^{ a , b , 1}\\) & \\(6.4^{ c , h , k }\\) \\\\\n\\hline Popma, et al. \\(2014{ }^{75}\\) & CV/489 \\({ }^{\\text {b }}\\) & 8.4 & 1.2 & 2.3 & \\(12.7^{ n } 24.9{ }^{\\text {c }}\\) & 11.8 & \\(8.2^{ c }\\) \\\\\n\\hline Adams, et al. \\(2014{ }^{66}\\) & CV/390 \\({ }^{\\text {a,d }}\\) & 3.3 & 0.8 & 3.9 & \\(13.6{ }^{\\text {n }} 28.1{ }^{\\text {c }}\\) & 6.0 & \\(5.9{ }^{\\text {c }}\\) \\\\\n\\hline Van Mieghem, & EW\\&XT/281 & 6.1 & 1.2 & 2.2 & \\(13.2^{ n }\\) & \\(7.3^{ p }\\) & \\(11.5^{ c }\\) \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Table 4.1-1: Events from Peri-Operative to 30 Days (Transfemoral Approach)}\n\\begin{tabular}{|l|l|l|l|l|l|l|l|}\n\\hline Study & Device/N & Death (\\%) & MI (\\%) & Stroke* (\\%) & Bleeding (\\%) & AKI (\\%) & VC (\\%) \\\\\n\\hline Webb, et al. \\(2009^{33}\\) & \\(EW / 113{ }^{ a }\\) & 8 & N/A & 5.3 & 11.6 & 4.4 & 8 \\\\\n\\hline Rodés-Cabau, et al. \\(2010^{41}\\) & \\(EW / 168{ }^{ a }\\) & 9.5 & 0.6 & 3.0 & N/A & N/A & N/A \\\\\n\\hline Thomas, et al. \\(2010^{42}\\) & EW/463 \\({ }^{\\text {a }}\\) & 6.3 & N/A & 2.4 & 9.9 & 1.3 & 22.9 \\\\\n\\hline Leon, et al. \\(2010^{14}\\) & EW/267 \\({ }^{\\text {b }}\\) & 5 & 0 & 5 & 16.8 & 1.1 & \\(16.2{ }^{\\text {c }}\\) 30.7 \\\\\n\\hline Smith, et al. \\(2011{ }^{64}\\) & \\(EW / 244^{ a , d }\\) & 3.4 & 0 & 3.8 & 9.3 & 2.9 & \\(14{ }^{\\text {c }}\\) 22.7 \\\\\n\\hline Piazza, et al. \\(2008^{40}\\) & CV/646 & 8 & 0.6 & \\(1.9{ }^{\\text {e }}\\) & N/A & N/A & 1.2 \\\\\n\\hline Munoz-Garcia, et al. \\(2012{ }^{74}\\) & CV/133 \\({ }^{\\text {f }}\\) & 4.5 & 0.8 & 1.5 & N/A & N/A & \\(2.2^{ c }\\) \\\\\n\\hline Buchanan, et al. \\(2011{ }^{35}\\) & CV, EW/305 & 4.7 & 1.3 & 1.0 & 33.1 & \\(10.2^{ g }\\) & \\(15.7^{ c }\\) \\\\\n\\hline Moat, et al. \\(2011{ }^{57}\\) & CV, EW/599 & 5.5 & 1.0 & \\(4.0{ }^{\\text {h }}\\) & N/A & N/A & 6.2 \\\\\n\\hline Zahn, et al. \\(2011{ }^{56}\\) & CV, EW \\(/ 697{ }^{ i }\\) & 12.4 & 0.3 & \\(2.8{ }^{\\text {e }}\\) & N/A & N/A & \\(17.1{ }^{ j }\\) \\\\\n\\hline Bosmans, et al. \\(2011{ }^{58}\\) & CV/133 \\({ }^{\\text {a }}\\) EW/99 \\({ }^{\\text {a }}\\) & 8 CV ; 6 EW & N/A & \\(5^{ e , k }\\) & N/A & \\(6^{ k , 1}\\) & N/A \\\\\n\\hline Tamburino, et al. \\(2012{ }^{36}\\) & CV, EW/218 \\({ }^{\\text {m }}\\) & 6.9 & 0.0 & 2.3 & 5.5 & N/A & N/A \\\\\n\\hline Gilard, et al. \\(2012{ }^{59}\\) & CV, EW/2361 \\({ }^{\\text {a }}\\) & 8.5 & 0.8 & 2.2 & \\(1.2^{ n }\\) & N/A & \\(5.5^{ c }\\) \\\\\n\\hline Spargias, et al. \\(2013{ }^{60}\\) & CV/67, EW/59 & 1.0 & N/A & \\(0.0{ }^{\\text {e }}\\) & \\(2.0^{ c }\\) & N/A & \\(9.0^{\\circ}\\) \\\\\n\\hline Mack, et al. \\(2013{ }^{62}\\) & EW/3833 \\({ }^{\\text {a,d,h }} EW / 1139^{ a , b , h }\\) EW/1687 \\({ }^{\\text {a,d }}\\) EW/489 \\({ }^{ a , b }\\) & \\(3.8^{ a , d , h } 5.4^{ a , b , h } 5.0{ }^{ a , d } 6.7{ }^{ a , b }\\) & \\(0.5^{ a , d , h } 0.8^{ a , b , h } N / A ^{ a , b , d }\\) & \\(3.8{ }^{\\text {a,d,e,h }} 5.4^{ a , b , e , h } 3.2^{ a , d , e } 1.6^{ a , b , e }\\) & \\(3.2{ }^{ a , c , d , h } 3.6^{ a , b , c , h } N / A ^{ a , b , d }\\) & \\(1.3^{ a , d , h , l } 1.7^{ a , b , h , l } 1.5^{ a , d , l } 1.6^{ a , b , 1}\\) & \\(6.4^{ c , h , k }\\) \\\\\n\\hline Popma, et al. \\(2014{ }^{75}\\) & CV/489 \\({ }^{\\text {b }}\\) & 8.4 & 1.2 & 2.3 & \\(12.7^{ n } 24.9{ }^{\\text {c }}\\) & 11.8 & \\(8.2^{ c }\\) \\\\\n\\hline Adams, et al. \\(2014{ }^{66}\\) & CV/390 \\({ }^{\\text {a,d }}\\) & 3.3 & 0.8 & 3.9 & \\(13.6{ }^{\\text {n }} 28.1{ }^{\\text {c }}\\) & 6.0 & \\(5.9{ }^{\\text {c }}\\) \\\\\n\\hline Van Mieghem, & EW\\&XT/281 & 6.1 & 1.2 & 2.2 & \\(13.2^{ n }\\) & \\(7.3^{ p }\\) & \\(11.5^{ c }\\) 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Study & Device/N & Death (\\%) & MI (\\%) & Stroke* (\\%) & Bleeding (\\%) & AKI (\\%) & VC (\\%) \\\\\n\\hline et al. \\(2013{ }^{38}\\) & CV/361 & & & & \\(19.6{ }^{\\text {c }}\\) & & \\\\\n\\hline Testa, et al. \\(2014{ }^{76}\\) & CV/1531 \\({ }^{ m }\\) & 5.9 & 2.0 & 2.0 & \\(15.0{ }^{\\text {c }}\\) & N/A & \\(2.7{ }^{\\text {c }}\\) \\\\\n\\hline Abdel-Wahab, et al. \\(2014{ }^{77}\\) & \\begin{tabular}{l}\nCV/117; \\\\\nEW/121\n\\end{tabular} & \\begin{tabular}{l}\n5.1 CV; \\\\\n4.1 EW\n\\end{tabular} & \\begin{tabular}{l}\n\\(0 CV ; 0.8\\) \\\\\nEW\n\\end{tabular} & \\begin{tabular}{l}\n\\(2.6{ }^{ e } CV\\); \\\\\n\\(5.8{ }^{ e } EW\\)\n\\end{tabular} & \\begin{tabular}{l}\n\\(12.0^{ n } CV\\) \\\\\n\\(8.3^{ n } EW\\) \\\\\n\\(14.5^{ c } CV\\) \\\\\n\\(19.0^{ c } EW\\)\n\\end{tabular} & \\begin{tabular}{l}\n9.4 CV \\\\\n4.1 EW\n\\end{tabular} & \\(11.1^{ c } CV 9.9{ }^{\\text {c }} EW\\) \\\\\n\\hline Webb, et al. \\(2014{ }^{78}\\) & S3/96 & 2.1 & 2.1 & 0.0 & \\begin{tabular}{l}\n\\(3.1^{ n }\\) \\\\\n\\(19.8{ }^{\\text {c }}\\)\n\\end{tabular} & \\(1.0^{ p }\\) & \\(4.2{ }^{\\text {c }}\\) \\\\\n\\hline Wenaweser, et al. \\(2014{ }^{79}\\) & \\begin{tabular}{l}\nCV/336 \\({ }^{\\text {q }}\\) \\\\\nSXT/317 \\({ }^{ q }\\)\n\\end{tabular} & 4.8 & 0.4 & 2.5 & \\begin{tabular}{l}\n\\(6.3^{\\text {n }}\\) \\\\\n\\(8.4{ }^{\\text {c }}\\)\n\\end{tabular} & \\(2.5^{ g }\\) & \\(6.3{ }^{\\text {c,h }}\\) \\\\\n\\hline Tarsia, et al. \\(2014{ }^{80}\\) & \\begin{tabular}{l}\nCV/53 \\\\\nEW and \\\\\nSXT/56\n\\end{tabular} & \\begin{tabular}{l}\n1.9 CV \\\\\n14.3 \\\\\nEW/SXT\n\\end{tabular} & N/A & \\begin{tabular}{l}\n1.9 CV \\\\\n0.0 \\\\\nEW/SXT\n\\end{tabular} & \\begin{tabular}{l}\n7.5 CV \\\\\n8.9 \\\\\nEW/SXT\n\\end{tabular} & N/A & \\begin{tabular}{l}\n1.9 CV \\\\\n7.1 \\\\\nEW/SXT\n\\end{tabular} \\\\\n\\hline De Brito, et al. \\(2015{ }^{81}\\) & \\begin{tabular}{l}\nCV/360 \\({ }^{\\text {f }}\\) \\\\\nSXT/58 \\({ }^{\\text {f }}\\)\n\\end{tabular} & 9.1 & 0.7 & 2.2 & \\begin{tabular}{l}\n\\(7.6^{ n }\\) \\\\\n\\(7.3{ }^{\\text {c }}\\)\n\\end{tabular} & \\(5.6^{ g }\\) & \\(8.5^{ c }\\) \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Table 4.1-1: Events from Peri-Operative to 30 Days (Transfemoral Approach)}\n\\begin{tabular}{|l|l|l|l|l|l|l|l|}\n\\hline Study & Device/N & Death (\\%) & MI (\\%) & Stroke* (\\%) & Bleeding (\\%) & AKI (\\%) & VC (\\%) \\\\\n\\hline et al. \\(2013{ }^{38}\\) & CV/361 & & & & \\(19.6{ }^{\\text {c }}\\) & & \\\\\n\\hline Testa, et al. \\(2014{ }^{76}\\) & CV/1531 \\({ }^{ m }\\) & 5.9 & 2.0 & 2.0 & \\(15.0{ }^{\\text {c }}\\) & N/A & \\(2.7{ }^{\\text {c }}\\) \\\\\n\\hline Abdel-Wahab, et al. \\(2014{ }^{77}\\) & \\begin{tabular}{l}\nCV/117; \\\\\nEW/121\n\\end{tabular} & \\begin{tabular}{l}\n5.1 CV; \\\\\n4.1 EW\n\\end{tabular} & \\begin{tabular}{l}\n\\(0 CV ; 0.8\\) \\\\\nEW\n\\end{tabular} & 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REPRISE I Study}","confidence":0.99658203125,"confidence_rate":0.9998731997676235},{"cnt":[[305,1113],[1828,1113],[1828,1171],[305,1171]],"region":{"top_left_x":305,"top_left_y":1112,"width":1524,"height":59},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e26b61857803458ebf56ee62e2674275","type":"text","conversion_output":true,"text":"As discussed above, TAVR in patients unsuitable for SAVR has reduced mortality \\({ }^{14,75}\\) and","text_display":"\n\nAs discussed above, TAVR in patients unsuitable for SAVR has reduced mortality \\({ }^{14,75}\\) and","confidence":1,"confidence_rate":1},{"cnt":[[305,1164],[1871,1164],[1871,1218],[305,1218]],"region":{"top_left_x":305,"top_left_y":1164,"width":1567,"height":55},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1939016c2e554efb82753a51c2d4b8b9","type":"text","conversion_output":true,"text":"treatment of selected patients at high surgical risk has resulted in similar \\({ }^{64}\\) or better \\({ }^{66}\\) survival","text_display":" treatment of selected patients at high surgical risk has resulted in similar \\({ }^{64}\\) or better \\({ }^{66}\\) survival","confidence":1,"confidence_rate":1},{"cnt":[[305,1216],[1766,1216],[1766,1265],[305,1265]],"region":{"top_left_x":305,"top_left_y":1216,"width":1462,"height":50},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6fbc4678bf4e4810aff7d8f46537943e","type":"text","conversion_output":true,"text":"at 1 year. These results notwithstanding, TAVR with early generation devices has been","text_display":" at 1 year. These results notwithstanding, TAVR with early generation devices has been","confidence":1,"confidence_rate":1},{"cnt":[[305,1265],[1850,1265],[1850,1313],[305,1313]],"region":{"top_left_x":305,"top_left_y":1265,"width":1545,"height":48},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6f3da61a672f4f4ea909fa0d0e59e978","type":"text","conversion_output":true,"text":"associated with increased stroke risk and vascular complications when compared to surgical","text_display":" associated with increased stroke risk and vascular complications when compared to surgical","confidence":1,"confidence_rate":1},{"cnt":[[305,1302],[1876,1302],[1876,1362],[305,1362]],"region":{"top_left_x":305,"top_left_y":1301,"width":1571,"height":62},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e72b63d3ceb44a49a3120eec6d72f04d","type":"text","conversion_output":true,"text":"valve replacement \\({ }^{64-66}\\), which have been significant predictors of mortality \\({ }^{84,85}\\). There are also","text_display":" valve replacement \\({ }^{64-66}\\), which have been significant predictors of mortality \\({ }^{84,85}\\). There are also","confidence":1,"confidence_rate":1},{"cnt":[[305,1360],[1867,1360],[1867,1412],[305,1412]],"region":{"top_left_x":305,"top_left_y":1359,"width":1562,"height":53},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a66038c037574ac6a7e708c410646bb7","type":"text","conversion_output":true,"text":"other infrequent but substantial complications that impact long-term outcomes and may limit","text_display":" other infrequent but substantial complications that impact long-term outcomes and may limit","confidence":1,"confidence_rate":1},{"cnt":[[305,1405],[1815,1405],[1815,1457],[305,1457]],"region":{"top_left_x":305,"top_left_y":1405,"width":1511,"height":52},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b579459da76143af8ff1dacd04f38d71","type":"text","conversion_output":true,"text":"the use of TAVR in lower risk subjects. Precise valve positioning can be challenging with","text_display":" the use of TAVR in lower risk subjects. Precise valve positioning can be challenging with","confidence":1,"confidence_rate":1},{"cnt":[[305,1454],[1785,1454],[1785,1506],[305,1506]],"region":{"top_left_x":305,"top_left_y":1454,"width":1481,"height":53},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0111d516d2c44b8aa64cb3272cd3e1ba","type":"text","conversion_output":true,"text":"first-generation devices, and valve misplacement can lead to severe problems, including","text_display":" first-generation devices, and valve misplacement can lead to severe problems, including","confidence":1,"confidence_rate":1},{"cnt":[[305,1497],[1833,1497],[1833,1553],[305,1553]],"region":{"top_left_x":305,"top_left_y":1497,"width":1528,"height":57},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5f0f706a0d664fa9bb38ea55a1e3e8a0","type":"text","conversion_output":true,"text":"coronary occlusion and valve embolization \\({ }^{86}\\). Incomplete apposition of the prosthesis with","text_display":" coronary occlusion and valve embolization \\({ }^{86}\\). Incomplete apposition of the prosthesis with","confidence":1,"confidence_rate":1},{"cnt":[[305,1551],[1712,1551],[1712,1601],[305,1601]],"region":{"top_left_x":305,"top_left_y":1551,"width":1408,"height":50},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d90fd31aa4614a69884cd84dc9c05575","type":"text","conversion_output":true,"text":"the native valve can occur in the presence of significant amounts of calcium or with","text_display":" the native valve can occur in the presence of significant amounts of calcium or with","confidence":1,"confidence_rate":1},{"cnt":[[305,1592],[1871,1592],[1871,1648],[305,1648]],"region":{"top_left_x":305,"top_left_y":1591,"width":1567,"height":57},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fb1b2f740476466c999e5e966f11dd0b","type":"text","conversion_output":true,"text":"suboptimal implantation, resulting in paravalvular regurgitation \\({ }^{87,88}\\). This has been associated","text_display":" suboptimal implantation, resulting in paravalvular regurgitation \\({ }^{87,88}\\). This has been associated","confidence":1,"confidence_rate":1},{"cnt":[[305,1641],[1738,1641],[1738,1695],[305,1695]],"region":{"top_left_x":305,"top_left_y":1641,"width":1434,"height":55},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f1037ac7357a4d82a2f8f0f84360da50","type":"text","conversion_output":true,"text":"with increased mortality in several longitudinal registries \\({ }^{45,89,90}\\). While careful patient","text_display":" with increased mortality in several longitudinal registries \\({ }^{45,89,90}\\). While careful patient","confidence":0.99951171875,"confidence_rate":0.9999954355197808},{"cnt":[[305,1689],[1798,1689],[1798,1747],[305,1747]],"region":{"top_left_x":305,"top_left_y":1688,"width":1494,"height":59},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5b0eafad86874470981992633703af44","type":"text","conversion_output":true,"text":"selection may serve to mitigate these risks \\({ }^{91-93}\\), device design improvements such as seen","text_display":" selection may serve to mitigate these risks \\({ }^{91-93}\\), device design improvements such as seen","confidence":0.9970703125,"confidence_rate":0.9999723212563202},{"cnt":[[305,1745],[1841,1745],[1841,1794],[305,1794]],"region":{"top_left_x":305,"top_left_y":1744,"width":1537,"height":50},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fac4d124553443d482c374f44ace81f8","type":"text","conversion_output":true,"text":"with the Lotus Valve System (including the ability to fully reposition and retrieve the valve","text_display":" with the Lotus Valve System (including the ability to fully reposition and retrieve the valve","confidence":1,"confidence_rate":1},{"cnt":[[305,1792],[1783,1792],[1783,1841],[305,1841]],"region":{"top_left_x":305,"top_left_y":1791,"width":1479,"height":51},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e00e2e7a5c3849719b3bcd4b7a801960","type":"text","conversion_output":true,"text":"and a unique adaptive seal to prevent leakage, see Section 5.1) may enable more precise","text_display":" and a unique adaptive seal to prevent leakage, see Section 5.1) may enable more precise","confidence":1,"confidence_rate":1},{"cnt":[[305,1839],[1390,1839],[1390,1888],[305,1888]],"region":{"top_left_x":305,"top_left_y":1839,"width":1086,"height":50},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"65d8a57831d044b1a38484598fcbf1cd","type":"text","conversion_output":true,"text":"placement and minimize or eliminate paravalvular regurgitation.","text_display":" placement and minimize or eliminate paravalvular regurgitation.","confidence":1,"confidence_rate":1},{"cnt":[[305,1908],[1706,1908],[1706,1957],[305,1957]],"region":{"top_left_x":305,"top_left_y":1907,"width":1401,"height":51},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b0d2059fe50b4b7db456e60e8b029fe2","type":"text","conversion_output":true,"text":"The prospective, single arm, multicenter REPRISE I (REpositionable Percutaneous","text_display":"\n\nThe prospective, single arm, multicenter REPRISE I (REpositionable Percutaneous","confidence":1,"confidence_rate":1},{"cnt":[[305,1955],[1772,1955],[1772,2004],[305,2004]],"region":{"top_left_x":305,"top_left_y":1955,"width":1468,"height":50},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"608d7b9b43b64c94a72dc54b88f783df","type":"text","conversion_output":true,"text":"Replacement of Stenotic Aortic Valve through Implantation of Lotus \\({ }^{ TM }\\) Valve Syst \\(\\underline{ E m}\\) )","text_display":" Replacement of Stenotic Aortic Valve through Implantation of Lotus \\({ }^{ TM }\\) Valve Syst \\(\\underline{ E m}\\) )","confidence":0.13253816646542455,"confidence_rate":0.9821181985642419},{"cnt":[[305,2002],[1751,2002],[1751,2052],[305,2052]],"region":{"top_left_x":305,"top_left_y":2002,"width":1446,"height":50},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9c3a8ee393b54a4da412e1329fbeb8ba","type":"text","conversion_output":true,"text":"feasibility study \\(( N =11)\\) assessed the acute safety and performance of the Lotus Valve","text_display":" feasibility study \\(( N =11)\\) assessed the acute safety and performance of the Lotus Valve","confidence":0.899215248808332,"confidence_rate":0.9988940199452552},{"cnt":[[305,2050],[1841,2050],[1841,2099],[305,2099]],"region":{"top_left_x":305,"top_left_y":2049,"width":1537,"height":51},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"af2ba1a28bc047a984c4a8c488421708","type":"text","conversion_output":true,"text":"System in symptomatic subjects with calcific aortic stenosis who were considered high risk","text_display":" System in symptomatic subjects with calcific aortic stenosis who were considered high risk","confidence":1,"confidence_rate":1},{"cnt":[[305,2093],[1777,2093],[1777,2151],[305,2151]],"region":{"top_left_x":305,"top_left_y":2092,"width":1472,"height":59},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ef99d575f92d42afba256b947e18cbc8","type":"text","conversion_output":true,"text":"for surgical valve replacement \\({ }^{94}\\). The primary endpoint was clinical procedural success,","text_display":" for surgical valve replacement \\({ }^{94}\\). The primary endpoint was clinical procedural success,","confidence":1,"confidence_rate":1},{"cnt":[[305,2140],[1850,2140],[1850,2198],[305,2198]],"region":{"top_left_x":305,"top_left_y":2139,"width":1545,"height":59},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"baf4f2e9f3744f22b0844e4c285104a5","type":"text","conversion_output":true,"text":"defined as successful implantation of a Lotus Valve (per the VARC-1 definitions \\({ }^{72}\\) ) without","text_display":" defined as successful implantation of a Lotus Valve (per the VARC-1 definitions \\({ }^{72}\\) ) without","confidence":1,"confidence_rate":1},{"cnt":[[305,2196],[1818,2196],[1818,2245],[305,2245]],"region":{"top_left_x":305,"top_left_y":2195,"width":1513,"height":51},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7056cadc1bea4bdf95200c0f4cb3c33e","type":"text","conversion_output":true,"text":"in-hospital major adverse cardiovascular and cerebrovascular events (MACCE, defined as","text_display":" in-hospital major adverse cardiovascular and cerebrovascular events (MACCE, defined as","confidence":1,"confidence_rate":1},{"cnt":[[305,2243],[1876,2243],[1876,2292],[305,2292]],"region":{"top_left_x":305,"top_left_y":2242,"width":1571,"height":51},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2e60e51255784374938895cc9ddd8f1d","type":"text","conversion_output":true,"text":"all-cause mortality, periprocedural myocardial infarction \\(\\leq 72\\) hours after the index procedure,","text_display":" all-cause mortality, periprocedural myocardial infarction \\(\\leq 72\\) hours after the index procedure,","confidence":1,"confidence_rate":1},{"cnt":[[305,2290],[1813,2290],[1813,2340],[305,2340]],"region":{"top_left_x":305,"top_left_y":2290,"width":1509,"height":50},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fdb25f3bec834b038797d8d051bcfadd","type":"text","conversion_output":true,"text":"major stroke, urgent/emergent conversion to surgery or repeat procedure for valve-related","text_display":" major stroke, urgent/emergent conversion to surgery or repeat procedure for valve-related","confidence":1,"confidence_rate":1},{"cnt":[[305,2340],[1794,2340],[1794,2391],[305,2391]],"region":{"top_left_x":305,"top_left_y":2339,"width":1489,"height":53},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"41a50c950da64a34b35ba5a5e9bbdb2a","type":"text","conversion_output":true,"text":"dysfunction) through discharge or 7 days post-procedure, whichever came first. Clinical","text_display":" dysfunction) through discharge or 7 days post-procedure, whichever came first. Clinical","confidence":1,"confidence_rate":1},{"cnt":[[305,2389],[1828,2389],[1828,2436],[305,2436]],"region":{"top_left_x":305,"top_left_y":2389,"width":1524,"height":48},"line":48,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2df4494e8d344dc28b06910b42b9b3ae","type":"text","conversion_output":true,"text":"follow-up will extend through 5 years. Safety endpoints are adjudicated by an independent","text_display":" follow-up will extend through 5 years. 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The study","text_display":"\nare assessed by independent echocardiography and electrocardiography core labs. 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Given the importance of","text_display":" an experienced proctoring physician assigned by Boston Scientific. Given the importance of","confidence":1,"confidence_rate":1},{"cnt":[[305,675],[1850,675],[1850,724],[305,724]],"region":{"top_left_x":305,"top_left_y":674,"width":1545,"height":51},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"60b402e978114c25a27becaf24567790","type":"text","conversion_output":true,"text":"selecting appropriate subjects, a Case Review Committee (CRC) comprised of the Principal","text_display":" selecting appropriate subjects, a Case Review Committee (CRC) comprised of the Principal","confidence":0.99365234375,"confidence_rate":0.9999315304271299},{"cnt":[[305,722],[1852,722],[1852,771],[305,771]],"region":{"top_left_x":305,"top_left_y":721,"width":1547,"height":51},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cee75c4ab6494d0db4392dfcd59bbf03","type":"text","conversion_output":true,"text":"Investigators, other investigators experienced with TAVR, and the Sponsor was established.","text_display":" Investigators, other investigators experienced with TAVR, and the Sponsor was established.","confidence":1,"confidence_rate":1},{"cnt":[[305,769],[1876,769],[1876,821],[305,821]],"region":{"top_left_x":305,"top_left_y":769,"width":1571,"height":52},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7aaa6bc673134b1ea94726867f8a0df6","type":"text","conversion_output":true,"text":"This committee was responsible for reviewing and confirming subject eligibility across study","text_display":" This committee was responsible for reviewing and confirming subject eligibility across study","confidence":1,"confidence_rate":1},{"cnt":[[305,819],[887,819],[887,870],[305,870]],"region":{"top_left_x":305,"top_left_y":818,"width":583,"height":53},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9a2fe06596f94c80b0b676318893ab9d","type":"text","conversion_output":true,"text":"sites during the screening process.","text_display":" sites during the screening process.","confidence":1,"confidence_rate":1},{"cnt":[[305,879],[1712,879],[1712,939],[305,939]],"region":{"top_left_x":305,"top_left_y":878,"width":1408,"height":61},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"280caa59df1f467c887031e4fdf2ea5e","type":"text","conversion_output":true,"text":"The primary endpoint was achieved in \\(9 / 11\\) subjects \\({ }^{94}\\). The device was successfully","text_display":"\nThe primary endpoint was achieved in \\(9 / 11\\) subjects \\({ }^{94}\\). The device was successfully","confidence":0.99169921875,"confidence_rate":0.9999174744491928},{"cnt":[[305,937],[1846,937],[1846,986],[305,986]],"region":{"top_left_x":305,"top_left_y":936,"width":1541,"height":51},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"55d9e1a0638e4682b3248c8cdfcac8bc","type":"text","conversion_output":true,"text":"implanted in all 11 subjects but there was a device failure in 1 subject based on not meeting","text_display":" implanted in all 11 subjects but there was a device failure in 1 subject based on not meeting","confidence":1,"confidence_rate":1},{"cnt":[[305,980],[1794,980],[1794,1033],[305,1033]],"region":{"top_left_x":305,"top_left_y":979,"width":1489,"height":55},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"52b7efe98724456b96c7b1fd13bcfc3e","type":"text","conversion_output":true,"text":"one of four VARC-1 criteria \\({ }^{72}\\) for device success (the mean gradient of 22 mmHg in this","text_display":" one of four VARC-1 criteria \\({ }^{72}\\) for device success (the mean gradient of 22 mmHg in this","confidence":1,"confidence_rate":1},{"cnt":[[305,1031],[1858,1031],[1858,1081],[305,1081]],"region":{"top_left_x":305,"top_left_y":1031,"width":1554,"height":50},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ac8e146c21a44f4d8726559aca0a60fc","type":"text","conversion_output":true,"text":"subject was greater than the VARC-1 cutoff of 20 mmHg ). The Echocardiography Core Lab","text_display":" subject was greater than the VARC-1 cutoff of 20 mmHg ). The Echocardiography Core Lab","confidence":1,"confidence_rate":1},{"cnt":[[305,1079],[1865,1079],[1865,1128],[305,1128]],"region":{"top_left_x":305,"top_left_y":1078,"width":1560,"height":50},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1e5b0124a54e497c96781338ccad0dae","type":"text","conversion_output":true,"text":"concluded that the device failure resulted from a hyperdynamic state in the subject and noted","text_display":" concluded that the device failure resulted from a hyperdynamic state in the subject and noted","confidence":1,"confidence_rate":1},{"cnt":[[305,1126],[1843,1126],[1843,1177],[305,1177]],"region":{"top_left_x":305,"top_left_y":1125,"width":1539,"height":53},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a847fe6e98504de499d955ac51865c0d","type":"text","conversion_output":true,"text":"that the prosthetic valve appeared to be functioning well. Ten (10) of 11 subjects had no in-","text_display":" that the prosthetic valve appeared to be functioning well. Ten (10) of 11 subjects had no in","confidence":1,"confidence_rate":1},{"cnt":[[305,1175],[1794,1175],[1794,1225],[305,1225]],"region":{"top_left_x":305,"top_left_y":1175,"width":1489,"height":50},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"451f2646a22141df9a0fdcb6b696e27d","type":"text","conversion_output":true,"text":"hospital MACCE; there were no deaths and 1 major stroke. Paravalvular regurgitation at","text_display":"hospital MACCE; there were no deaths and 1 major stroke. Paravalvular regurgitation at","confidence":1,"confidence_rate":1},{"cnt":[[305,1222],[1852,1222],[1852,1274],[305,1274]],"region":{"top_left_x":305,"top_left_y":1222,"width":1547,"height":53},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a5e144e9f18a4a29a042ce95f2bab165","type":"text","conversion_output":true,"text":"discharge TTE was mild in 2 subjects, trivial in 1 subject, and absent in the other 8 subjects;","text_display":" discharge TTE was mild in 2 subjects, trivial in 1 subject, and absent in the other 8 subjects;","confidence":1,"confidence_rate":1},{"cnt":[[305,1263],[1412,1263],[1412,1321],[305,1321]],"region":{"top_left_x":305,"top_left_y":1263,"width":1107,"height":59},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3e50b5a7b70d4070910faba0af4c6cd3","type":"text","conversion_output":true,"text":"these outcomes compare favorably with published data \\({ }^{14,40,56,64,95}\\).","text_display":" these outcomes compare favorably with published data \\({ }^{14,40,56,64,95}\\).","confidence":1,"confidence_rate":1},{"cnt":[[305,1330],[1837,1330],[1837,1390],[305,1390]],"region":{"top_left_x":305,"top_left_y":1329,"width":1532,"height":62},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b210366296734a25a2ab979238de7c71","type":"text","conversion_output":true,"text":"To date, data are available through 3 years \\({ }^{94,96,97}\\). There were no additional MACCE events","text_display":"\nTo date, data are available through 3 years \\({ }^{94,96,97}\\). There were no additional MACCE events","confidence":1,"confidence_rate":1},{"cnt":[[305,1388],[1833,1388],[1833,1437],[305,1437]],"region":{"top_left_x":305,"top_left_y":1387,"width":1528,"height":51},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"aaaee329f36a4e329ddc14b503e69472","type":"text","conversion_output":true,"text":"beyond the primary endpoint through 2 years and 1 noncardiovascular death in the interval","text_display":" beyond the primary endpoint through 2 years and 1 noncardiovascular death in the interval","confidence":1,"confidence_rate":1},{"cnt":[[305,1429],[1867,1429],[1867,1485],[305,1485]],"region":{"top_left_x":305,"top_left_y":1428,"width":1562,"height":57},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f01a0ee078b14280aac4fcbdefb5a102","type":"text","conversion_output":true,"text":"between 2 and 3 years. The 3 -year VARC-1 \\({ }^{72}\\) combined safety endpoint, including MACCE,","text_display":" between 2 and 3 years. The 3 -year VARC-1 \\({ }^{72}\\) combined safety endpoint, including MACCE,","confidence":0.9980475902557373,"confidence_rate":0.9999823936848974},{"cnt":[[305,1482],[1841,1482],[1841,1532],[305,1532]],"region":{"top_left_x":305,"top_left_y":1482,"width":1537,"height":50},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"77fb14ddd7b94d2088d39027759076cf","type":"text","conversion_output":true,"text":"life threatening/disabling bleeding, major vascular complications, and Stage 3 acute kidney","text_display":" life threatening/disabling bleeding, major vascular complications, and Stage 3 acute kidney","confidence":1,"confidence_rate":1},{"cnt":[[305,1530],[1772,1528],[1773,1581],[305,1583]],"region":{"top_left_x":305,"top_left_y":1527,"width":1468,"height":57},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b17655c673a1409aa7b4e8371da7746c","type":"text","conversion_output":true,"text":"injury, was 4/11; the aforementioned subject with the major stroke also had a small left","text_display":" injury, was 4/11; the aforementioned subject with the major stroke also had a small left","confidence":0.9580078125,"confidence_rate":0.999538823084091},{"cnt":[[305,1577],[1846,1577],[1846,1629],[305,1629]],"region":{"top_left_x":305,"top_left_y":1576,"width":1541,"height":53},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4dc779e37f6648e89b38888bee293971","type":"text","conversion_output":true,"text":"femoral dissection treated with balloon inflation during the procedure and there were 2 life-","text_display":" femoral dissection treated with balloon inflation during the procedure and there were 2 life","confidence":1,"confidence_rate":1},{"cnt":[[305,1626],[1833,1626],[1833,1678],[305,1678]],"region":{"top_left_x":305,"top_left_y":1626,"width":1528,"height":52},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a3e79cc54606452a83d99bbc94b16f29","type":"text","conversion_output":true,"text":"threatening/disabling bleeds through 30 days that were unrelated to valve implantation and","text_display":"threatening/disabling bleeds through 30 days that were unrelated to valve implantation and","confidence":1,"confidence_rate":1},{"cnt":[[305,1676],[1820,1676],[1820,1725],[305,1725]],"region":{"top_left_x":305,"top_left_y":1675,"width":1515,"height":51},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ad5c2bf21150448aa6f7b6c46842cbb9","type":"text","conversion_output":true,"text":"resolved, and there was 1 noncardiovascular death due to uncontrolled sepsis. Conduction","text_display":" resolved, and there was 1 noncardiovascular death due to uncontrolled sepsis. Conduction","confidence":1,"confidence_rate":1},{"cnt":[[305,1723],[1790,1723],[1790,1772],[305,1772]],"region":{"top_left_x":305,"top_left_y":1723,"width":1485,"height":50},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d6b5e99de61845da98589b074880a0fa","type":"text","conversion_output":true,"text":"disturbances led to implantation of a permanent pacemaker (PPM) before discharge in 4","text_display":" disturbances led to implantation of a permanent pacemaker (PPM) before discharge in 4","confidence":0.99951171875,"confidence_rate":0.9999945123690109},{"cnt":[[305,1770],[1813,1770],[1813,1824],[305,1824]],"region":{"top_left_x":305,"top_left_y":1770,"width":1509,"height":55},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c224f011584e490a906e8ab75846a41c","type":"text","conversion_output":true,"text":"subjects; 2 of these 4 subjects had paced rhythms at 1 year. While all REPRISE I subjects","text_display":" subjects; 2 of these 4 subjects had paced rhythms at 1 year. While all REPRISE I subjects","confidence":1,"confidence_rate":1},{"cnt":[[305,1818],[1738,1818],[1738,1869],[305,1869]],"region":{"top_left_x":305,"top_left_y":1817,"width":1434,"height":53},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3a2c26fb4b9c489f892d16db6b2d86ae","type":"text","conversion_output":true,"text":"were NYHA Class II ( \\(n =6\\) ) or III ( \\(n =5\\) ) at baseline, this distribution was significantly","text_display":" were NYHA Class II ( \\(n =6\\) ) or III ( \\(n =5\\) ) at baseline, this distribution was significantly","confidence":0.914458816871047,"confidence_rate":0.9991646215934754},{"cnt":[[305,1865],[1824,1865],[1824,1919],[305,1919]],"region":{"top_left_x":305,"top_left_y":1864,"width":1520,"height":55},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6ad5b461a9574ceaa3bba9de2109f9b0","type":"text","conversion_output":true,"text":"improved between baseline and 30 days ( 3 in Class I, 7 in Class II, 1 in Class III; \\(P=0.02\\) ),","text_display":" improved between baseline and 30 days ( 3 in Class I, 7 in Class II, 1 in Class III; \\(P=0.02\\) ),","confidence":1,"confidence_rate":1},{"cnt":[[305,1914],[1833,1914],[1833,1966],[305,1966]],"region":{"top_left_x":305,"top_left_y":1914,"width":1528,"height":52},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6fdc5376025b4135b97ded93561fbf74","type":"text","conversion_output":true,"text":"baseline and 1 year (5 in Class I, 6 in Class II; \\(P=0.004\\) ), baseline and 2 years (6 in Class I,","text_display":" baseline and 1 year (5 in Class I, 6 in Class II; \\(P=0.004\\) ), baseline and 2 years (6 in Class I,","confidence":0.8540265560150146,"confidence_rate":0.9986045763718128},{"cnt":[[305,1962],[1811,1962],[1811,2013],[305,2013]],"region":{"top_left_x":305,"top_left_y":1961,"width":1507,"height":53},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7e8e8b01eff04103a714f8e1652ed646","type":"text","conversion_output":true,"text":"5 in Class II; \\(P=0.004\\) ), and baseline and 3 years (5 in Class I, 1 in Class II, 2 in Class III;","text_display":" 5 in Class II; \\(P=0.004\\) ), and baseline and 3 years (5 in Class I, 1 in Class II, 2 in Class III;","confidence":0.9405956268310547,"confidence_rate":0.9994533462658617},{"cnt":[[305,2011],[1800,2011],[1800,2060],[305,2060]],"region":{"top_left_x":305,"top_left_y":2010,"width":1496,"height":51},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f94e1db27c8346b3bee4dc303eb9666f","type":"text","conversion_output":true,"text":"\\(P=0.004\\) ). The mean aortic valve gradient was \\(11.7 \\pm 3.0 mmHg\\) for the cohort at 30 days,","text_display":" \\(P=0.004\\) ). The mean aortic valve gradient was \\(11.7 \\pm 3.0 mmHg\\) for the cohort at 30 days,","confidence":0.9390237188199535,"confidence_rate":0.9993582209218804},{"cnt":[[305,2058],[1755,2058],[1755,2108],[305,2108]],"region":{"top_left_x":305,"top_left_y":2058,"width":1451,"height":50},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4ae0c9920d8b45cdaef4862078159757","type":"text","conversion_output":true,"text":"\\(15.4 \\pm 4.6 mmHg\\) at 1 year, \\(15.4 \\pm 4.4 mmHg\\) at 2 years, and \\(15.6 \\pm 4.4 mmHg\\) at 3 years.","text_display":" \\(15.4 \\pm 4.6 mmHg\\) at 1 year, \\(15.4 \\pm 4.4 mmHg\\) at 2 years, and \\(15.6 \\pm 4.4 mmHg\\) at 3 years.","confidence":0.9970703125,"confidence_rate":0.9999720576529205},{"cnt":[[305,2105],[1846,2105],[1846,2157],[305,2157]],"region":{"top_left_x":305,"top_left_y":2105,"width":1541,"height":53},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d30db27ad98f4c008b63a78bae139930","type":"text","conversion_output":true,"text":"Paravalvular aortic regurgitation was mild (2/11) or absent (9/11) at 30 days, mild (1/11) or","text_display":" Paravalvular aortic regurgitation was mild (2/11) or absent (9/11) at 30 days, mild (1/11) or","confidence":0.9883264825130522,"confidence_rate":0.9998837474713891},{"cnt":[[305,2153],[1876,2153],[1876,2204],[305,2204]],"region":{"top_left_x":305,"top_left_y":2152,"width":1571,"height":53},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8fa46d8b1b224a5a9e36b1eaa944230f","type":"text","conversion_output":true,"text":"absent/trivial (10/11) at 1 year, absent/trivial (11/11) at 2 years, and absent (7/8) or mild (1/8)","text_display":" absent/trivial (10/11) at 1 year, absent/trivial (11/11) at 2 years, and absent (7/8) or mild (1/8)","confidence":0.99853515625,"confidence_rate":0.9999866735644114},{"cnt":[[305,2202],[1865,2202],[1865,2254],[305,2254]],"region":{"top_left_x":305,"top_left_y":2202,"width":1560,"height":52},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6a02b89048fa4c11981be85f31a9f09c","type":"text","conversion_output":true,"text":"at 3 years; there was no moderate or severe paravalvular aortic regurgitation at any time post","text_display":" at 3 years; there was no moderate or severe paravalvular aortic regurgitation at any time post","confidence":1,"confidence_rate":1},{"cnt":[[305,2247],[1841,2247],[1841,2301],[305,2301]],"region":{"top_left_x":305,"top_left_y":2247,"width":1537,"height":54},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3ade211edef44c1e8da4fb8795b72751","type":"text","conversion_output":true,"text":"implantation of the Lotus Valve. 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The primary device performance","text_display":" echocardiography and electrocardiography core labs. The primary device performance","confidence":1,"confidence_rate":1},{"cnt":[[309,1149],[1867,1149],[1867,1197],[309,1197]],"region":{"top_left_x":309,"top_left_y":1149,"width":1558,"height":48},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8a6a4ee54bfc4ae3b5849b68d0568bce","type":"text","conversion_output":true,"text":"endpoint was the mean aortic valve pressure gradient at 30 days post implant as measured by","text_display":" endpoint was the mean aortic valve pressure gradient at 30 days post implant as measured by","confidence":0.9970703125,"confidence_rate":0.9999703642024339},{"cnt":[[309,1199],[1828,1199],[1828,1244],[309,1244]],"region":{"top_left_x":309,"top_left_y":1198,"width":1520,"height":46},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c66c20fd78f84f57b9a2cbc26ef94879","type":"text","conversion_output":true,"text":"echocardiography. This endpoint was analyzed on an as-treated (subjects who received the","text_display":" echocardiography. This endpoint was analyzed on an as-treated (subjects who received the","confidence":1,"confidence_rate":1},{"cnt":[[309,1246],[1807,1246],[1807,1291],[309,1291]],"region":{"top_left_x":309,"top_left_y":1246,"width":1498,"height":46},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"064b1ff4ed664212ad2e16bccda84bba","type":"text","conversion_output":true,"text":"Lotus Valve) basis. A one-sample \\(t\\)-test was used to test the one-sided hypothesis that the","text_display":" Lotus Valve) basis. 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Two interim analyses were conducted on the first 40 and 60 subjects; the alpha-","text_display":" 18 mmHg . Two interim analyses were conducted on the first 40 and 60 subjects; the alpha","confidence":0.994140625,"confidence_rate":0.9999418174502049},{"cnt":[[309,1388],[1867,1388],[1867,1437],[309,1437]],"region":{"top_left_x":309,"top_left_y":1387,"width":1558,"height":51},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d4aaa1c31a714ee691a35265484cd852","type":"text","conversion_output":true,"text":"adjustment for multiple comparisons was 0.01123 and 0.00792 , respectively. The alpha level","text_display":"adjustment for multiple comparisons was 0.01123 and 0.00792 , respectively. The alpha level","confidence":1,"confidence_rate":1},{"cnt":[[309,1437],[1837,1437],[1837,1485],[309,1485]],"region":{"top_left_x":309,"top_left_y":1437,"width":1528,"height":48},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0a55872e122a41b984b09f0b30621227","type":"text","conversion_output":true,"text":"adjustment for the final analysis conducted on the fully enrolled cohort of 120 subjects was","text_display":" adjustment for the final analysis conducted on the fully enrolled cohort of 120 subjects was","confidence":0.99951171875,"confidence_rate":0.9999951160069457},{"cnt":[[309,1485],[1798,1485],[1798,1532],[309,1532]],"region":{"top_left_x":309,"top_left_y":1484,"width":1490,"height":48},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"17a2ad4d783f40b6ad76d350afad4e0d","type":"text","conversion_output":true,"text":"0.01305.The primary safety endpoint was all-cause mortality at 30 days after the implant","text_display":" 0.01305.The primary safety endpoint was all-cause mortality at 30 days after the implant","confidence":0.9455942502245307,"confidence_rate":0.9994174435758131},{"cnt":[[309,1534],[1244,1534],[1244,1579],[309,1579]],"region":{"top_left_x":309,"top_left_y":1533,"width":935,"height":47},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4283bff0a67a49b1910221e9a8007dac","type":"text","conversion_output":true,"text":"procedure and was evaluated on an intent-to-treat basis.","text_display":" procedure and was evaluated on an intent-to-treat basis.","confidence":1,"confidence_rate":1},{"cnt":[[309,1603],[1798,1603],[1798,1648],[309,1648]],"region":{"top_left_x":309,"top_left_y":1602,"width":1490,"height":46},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4b54fefe96954ce5bac8a0d4a71a1904","type":"text","conversion_output":true,"text":"The 30-day mean aortic valve pressure gradient was \\(11.45 \\pm 5.20 mmHg\\) with a one-sided","text_display":"\n\nThe 30-day mean aortic valve pressure gradient was \\(11.45 \\pm 5.20 mmHg\\) with a one-sided","confidence":0.9854077873751521,"confidence_rate":0.9998419509195869},{"cnt":[[309,1650],[1772,1650],[1772,1695],[309,1695]],"region":{"top_left_x":309,"top_left_y":1650,"width":1464,"height":46},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"873a9c102d0741e1b033563b691cf152","type":"text","conversion_output":true,"text":"\\(98.695 \\%\\) upper confidence bound of 12.64 . 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Table 4.1-2","text_display":" gradient \\(<18 mmHg\\) and the primary device performance endpoint was met. Table 4.1-2","confidence":1,"confidence_rate":1},{"cnt":[[309,1794],[1815,1794],[1815,1839],[309,1839]],"region":{"top_left_x":309,"top_left_y":1793,"width":1507,"height":47},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2d586f30437c48878ad130ef7b0c3125","type":"text","conversion_output":true,"text":"shows device performance endpoints, clinical outcomes, and echocardiographic outcomes","text_display":" shows device performance endpoints, clinical outcomes, and echocardiographic outcomes","confidence":1,"confidence_rate":1},{"cnt":[[309,1835],[1833,1835],[1833,1888],[309,1888]],"region":{"top_left_x":309,"top_left_y":1834,"width":1524,"height":55},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7c9fb9334b1b4a908d68093eeaf47407","type":"text","conversion_output":true,"text":"through 30 days \\({ }^{98}\\). Successful vascular access, delivery and deployment of the Lotus Valve","text_display":" through 30 days \\({ }^{98}\\). 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The observed","text_display":" (80/96) of subjects there was trace/trivial or no paravalvular regurgitation. The observed","confidence":1,"confidence_rate":1},{"cnt":[[309,2220],[309,2174],[1790,2176],[1790,2222]],"region":{"top_left_x":309,"top_left_y":2174,"width":1481,"height":48},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"523e97c7e7d346ab8578efc0d583577a","type":"text","conversion_output":true,"text":"clinical results are consistent with other TAVR studies (see Table 4.1-1) and the rates of","text_display":" clinical results are consistent with other TAVR studies (see Table 4.1-1) and the rates of","confidence":1,"confidence_rate":1},{"cnt":[[309,2217],[1790,2217],[1790,2271],[309,2271]],"region":{"top_left_x":309,"top_left_y":2217,"width":1481,"height":54},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"76b5db8a350a464c9a252af1abc84e8b","type":"text","conversion_output":true,"text":"paravalvular regurgitation are lower \\({ }^{14,64,66,75,77}\\). Table 4.1-3 shows 1-year \\({ }^{99}\\) and 2-year \\({ }^{100}\\)","text_display":" paravalvular regurgitation are lower \\({ }^{14,64,66,75,77}\\). Table 4.1-3 shows 1-year \\({ }^{99}\\) and 2-year \\({ }^{100}\\)","confidence":0.8640414783731103,"confidence_rate":0.9988499963761028},{"cnt":[[309,2273],[1846,2273],[1846,2318],[309,2318]],"region":{"top_left_x":309,"top_left_y":2273,"width":1537,"height":46},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"62dd9e76279f4784a8e6fc6fde94fcf8","type":"text","conversion_output":true,"text":"clinical (time-to-event analysis) and echocardiographic outcomes. At 2 years, mortality was","text_display":" clinical (time-to-event analysis) and echocardiographic outcomes. At 2 years, mortality was","confidence":1,"confidence_rate":1},{"cnt":[[312,2320],[1824,2320],[1824,2365],[312,2365]],"region":{"top_left_x":311,"top_left_y":2320,"width":1514,"height":46},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b8e33b38aea94b2fb6d690610c74eae4","type":"text","conversion_output":true,"text":"\\(17 \\%\\) and the disabling stroke rate was \\(3.5 \\%\\). The low paravalvular aortic regurgitation rate","text_display":" \\(17 \\%\\) and the disabling stroke rate was \\(3.5 \\%\\). The low paravalvular aortic regurgitation rate","confidence":1,"confidence_rate":1},{"cnt":[[309,2368],[1755,2368],[1755,2415],[309,2415]],"region":{"top_left_x":309,"top_left_y":2367,"width":1447,"height":48},"line":48,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"428ee5ecf4b24d4cb2fa700f08bc677c","type":"text","conversion_output":true,"text":"observed at 30 days was maintained at 2 years as most subjects ( \\(91 \\%\\) ) had none/trivial","text_display":" observed at 30 days was maintained at 2 years as most subjects ( \\(91 \\%\\) ) had none/trivial","confidence":0.7797246798872948,"confidence_rate":0.9975395230753304},{"cnt":[[309,2415],[1695,2415],[1695,2464],[309,2464]],"region":{"top_left_x":309,"top_left_y":2414,"width":1387,"height":51},"line":49,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"30eea64764a14c7f8c3feddcb89abacb","type":"text","conversion_output":true,"text":"paravalvular aortic regurgitation and there was no moderate or severe paravalvular","text_display":" paravalvular aortic regurgitation and there was no moderate or severe paravalvular","confidence":1,"confidence_rate":1},{"cnt":[[103,2651],[312,2651],[312,2688],[103,2688]],"region":{"top_left_x":103,"top_left_y":2651,"width":209,"height":37},"line":50,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3c03f97fc7b445c3858438cec4041bcb","type":"page_info","conversion_output":false,"text":"Released","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[829,2655],[1291,2655],[1291,2688],[829,2688]],"region":{"top_left_x":829,"top_left_y":2655,"width":463,"height":33},"line":51,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b92f4db407aa4a26b1e609162ada54ce","type":"page_info","conversion_output":false,"text":"REPRISE III Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1656,2655],[1981,2655],[1981,2688],[1656,2688]],"region":{"top_left_x":1656,"top_left_y":2655,"width":325,"height":33},"line":52,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4f844ac786b24d30bb9d229c78d147d8","type":"page_info","conversion_output":false,"text":"90899936 AK. 4","text_display":"","confidence":0.99658203125,"confidence_rate":0.999798618906392},{"cnt":[[488,2690],[2000,2690],[2000,2731],[488,2731]],"region":{"top_left_x":487,"top_left_y":2689,"width":1514,"height":42},"line":53,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e775d1c7c0b14bec8e74c71dbc4f5e6a","type":"page_info","conversion_output":false,"text":"Boston Scientific Confidential. 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The results of the REPRISE II study support the safety and performance of the","text_display":"\nregurgitation. The results of the REPRISE II study support the safety and performance of the","confidence":1,"confidence_rate":1},{"cnt":[[305,417],[662,417],[662,466],[305,466]],"region":{"top_left_x":305,"top_left_y":416,"width":357,"height":51},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"79dbefcfddae4cd3965d84f0baa7c525","type":"text","conversion_output":true,"text":"Lotus Valve System.","text_display":" Lotus Valve System.","confidence":0.99853515625,"confidence_rate":0.9999389219619019},{"cnt":[[481,494],[1704,494],[1704,544],[481,544]],"region":{"top_left_x":481,"top_left_y":494,"width":1223,"height":50},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e75d70b481984c45b509e164ba29a4d8","type":"figure_label","conversion_output":false,"text":"Table 4.1-2: 30-Day Outcomes in REPRISE II Main Cohort ( \\(N = 1 2 0\\) 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Outcomes & REPRISE II ( \\(N = 1 2 0\\) ) \\\\\n\\hline \\multicolumn{2}{|l|}{Clinical Outcomes at 30 Days (CEC Adjudicated)} \\\\\n\\hline All-cause mortality & 4.2\\% (5/119) \\\\\n\\hline Cardiovascular & 4.2\\% (5/119) \\\\\n\\hline All stroke & 6.1\\% (7/115) \\\\\n\\hline Disabling stroke & 1.7\\% (2/115) \\\\\n\\hline Major vascular complications & 2.6\\% (3/116) \\\\\n\\hline Life-threatening or disabling bleeding & 5.1\\% (6/117) \\\\\n\\hline Major bleeding & 17.9\\% (21/117) \\\\\n\\hline Acute kidney injury - Stage 2 or 3 & 3.5\\% (4/115) \\\\\n\\hline Coronary obstruction (periprocedural) & 0.9\\% (1/115) \\\\\n\\hline Valve-related dysfunction requiring repeat procedure (surgical/interventional) & 0.0\\% (0/115) \\\\\n\\hline New permanent pacemaker implantation resulting from new or worsened conduction disturbances & 29.1\\% (34/117) \\\\\n\\hline Periprocedural MI ( \\(\\leq 72\\) hours after index procedure) & 3.4\\% (4/117) \\\\\n\\hline Hospitalization for valve-related symptoms or worsening congestive heart failure & 4.3\\% (5/115) \\\\\n\\hline Atrial fibrillation or atrial flutter (new onset) & 5.2\\% (6/115) \\\\\n\\hline Ventricular septal perforation (periprocedural) & 0.0\\% (0/115) \\\\\n\\hline Mitral apparatus damage (periprocedural) & 2.6\\% (3/115) \\\\\n\\hline Cardiac tamponade (periprocedural) & 4.3\\% (5/117) \\\\\n\\hline Prosthetic aortic valve malpositioning & 0.0\\% (0/115) \\\\\n\\hline Prosthetic aortic valve thrombosis & 0.0\\% (0/115) \\\\\n\\hline Prosthetic aortic valve endocarditis & 0.0\\% (0/115) \\\\\n\\hline \\multicolumn{2}{|l|}{Device Performance Endpoints} \\\\\n\\hline Successful vascular access, delivery, and deployment of the Lotus Valve System, and successful retrieval of the delivery system & 100.0\\% (120/120) \\\\\n\\hline Successful repositioning (partial or complete resheathing of the Lotus Valve in the catheter and redeployment in a more accurate position within the aortic valve annulus) of the Lotus Valve System if repositioning is attempted for the last valve attempted & 100.0\\% (32/32) \\\\\n\\hline Successful retrieval (complete resheathing of the Lotus Valve in the catheter and removal from the body) of the Lotus Valve System if retrieval is attempted & 100.0\\% (6/6) \\\\\n\\hline \\multicolumn{2}{|l|}{Valve Performance by Transthoracic Echocardiography (30 Days-Core Lab Assessment)} \\\\\n\\hline Aortic valve area (effective orifice area) ( \\(cm ^{2}\\) ) & \\(1.67 \\pm 0.43\\) (78) \\\\\n\\hline Mean aortic valve gradient (mmHg) & \\(11.45 \\pm 5.20(97)\\) \\\\\n\\hline Peak aortic gradient (mmHg) & \\(21.30 \\pm 9.26(97)\\) \\\\\n\\hline Peak aortic velocity (cm/s) & \\(2.25 \\pm 0.48(97)\\) \\\\\n\\hline \\multicolumn{2}{|l|}{Paravalvular Aortic Regurgitation} \\\\\n\\hline None & 78.1\\% (75/96) \\\\\n\\hline Trace/trivial & 5.2\\% (5/96) \\\\\n\\hline Mild & 15.6\\% (15/96) 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implantation resulting from new or worsened conduction disturbances & 29.1\\% (34/117) \\\\\n\\hline Periprocedural MI ( \\(\\leq 72\\) hours after index procedure) & 3.4\\% (4/117) \\\\\n\\hline Hospitalization for valve-related symptoms or worsening congestive heart failure & 4.3\\% (5/115) \\\\\n\\hline Atrial fibrillation or atrial flutter (new onset) & 5.2\\% (6/115) \\\\\n\\hline Ventricular septal perforation (periprocedural) & 0.0\\% (0/115) \\\\\n\\hline Mitral apparatus damage (periprocedural) & 2.6\\% (3/115) \\\\\n\\hline Cardiac tamponade (periprocedural) & 4.3\\% (5/117) \\\\\n\\hline Prosthetic aortic valve malpositioning & 0.0\\% (0/115) \\\\\n\\hline Prosthetic aortic valve thrombosis & 0.0\\% (0/115) \\\\\n\\hline Prosthetic aortic valve endocarditis & 0.0\\% (0/115) \\\\\n\\hline \\multicolumn{2}{|l|}{Device Performance Endpoints} \\\\\n\\hline Successful vascular access, delivery, and deployment of the Lotus Valve System, and successful retrieval of the delivery 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Outcomes & REPRISE II 1 Year & REPRISE II 2 Years \\\\\n\\hline \\multicolumn{3}{|l|}{Clinical Outcomes at 1 Year and 2 Years (CEC Adjudicated)} \\\\\n\\hline All-cause mortality & 11.0\\% (13) & 16.9\\% (20) \\\\\n\\hline Cardiovascular & 6.7\\% (8) & 10.4\\% (12) \\\\\n\\hline All stroke & 9.5\\% (11) & 9.5\\% (11) \\\\\n\\hline Disabling stroke & 3.5\\% (4) & 3.5\\% (4) \\\\\n\\hline Major vascular complications & 2.5\\% (3) & 2.5\\% (3) \\\\\n\\hline Life-threatening or disabling bleeding & 5.9\\% (7) & 7.8\\% (9) \\\\\n\\hline Major bleeding & 21.4\\% (25) & 23.3\\% (27) \\\\\n\\hline Acute kidney injury - Stage 2 or 3 & 3.4\\% (4) & 3.4\\% (4) \\\\\n\\hline Valve-related dysfunction requiring repeat procedure (surgical/interventional) & 0.0\\% (0) & 0.0\\% (0) \\\\\n\\hline New permanent pacemaker implantation resulting from new or worsened conduction disturbances & 32.2\\% (38) & 34.2\\% (40) \\\\\n\\hline Spontaneous MI (> 72 hours after index procedure) & 0.0\\% (0) & 0.0\\% (0) \\\\\n\\hline Hospitalization for valve-related symptoms or worsening congestive heart failure & 5.2\\% (6) & 8.0\\% (9) \\\\\n\\hline Atrial fibrillation or atrial flutter (new onset) & 6.0\\% (7) & 6.0\\% (7) \\\\\n\\hline Prosthetic aortic valve malpositioning & 0.0\\% (0) & 0.0\\% (0) \\\\\n\\hline Prosthetic aortic valve thrombosis & 0.0\\% (0) & 0.0\\% (0) \\\\\n\\hline Prosthetic aortic valve endocarditis & 0.9\\% (1) & 2.8\\% (3) \\\\\n\\hline \\multicolumn{3}{|l|}{Valve Performance by Transthoracic Echocardiography (1 Year and 2-Years -Core Lab Assessment)} \\\\\n\\hline Aortic valve area (effective orifice area) (cm) & \\(1.65 \\pm 0.51\\) (79) & \\(1.66 \\pm 0.45\\) (69) \\\\\n\\hline Mean aortic valve gradient (mmHg) & \\(12.58 \\pm 5.66(92)\\) & \\(12.30 \\pm 6.18\\) (75) \\\\\n\\hline Peak aortic gradient (mmHg) & \\(23.09 \\pm 10.14(92)\\) & \\(21.25 \\pm 11.03(75)\\) \\\\\n\\hline Peak aortic velocity (cm/s) & \\(2.35 \\pm 0.50\\) (92) & \\(2.23 \\pm 0.56(75)\\) \\\\\n\\hline \\multicolumn{3}{|l|}{Paravalvular Aortic Regurgitation} \\\\\n\\hline None & 86.4\\% (76/88) & 87.8\\% (65/74) \\\\\n\\hline Trace/trivial & 2.3\\% (2/88) & 2.7\\% (2/74) \\\\\n\\hline Mild & 11.4\\% (10/88) & 9.5\\% (7/74) \\\\\n\\hline Moderate & 0.0\\% (0/88) & 0.0\\% (0/74) \\\\\n\\hline Severe & 0.0\\% (0/88) & 0.0\\% (0/74) \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Table 4.1-3: 1-Year and 2-Year Outcomes in REPRISE II Main Cohort ( \\(N = 1 2 0\\) )}\n\\begin{tabular}{|l|l|l|}\n\\hline Outcomes & REPRISE II 1 Year & REPRISE II 2 Years \\\\\n\\hline \\multicolumn{3}{|l|}{Clinical Outcomes at 1 Year and 2 Years (CEC Adjudicated)} \\\\\n\\hline All-cause mortality & 11.0\\% (13) & 16.9\\% (20) \\\\\n\\hline Cardiovascular & 6.7\\% (8) & 10.4\\% (12) \\\\\n\\hline All stroke & 9.5\\% (11) & 9.5\\% (11) \\\\\n\\hline Disabling stroke & 3.5\\% (4) & 3.5\\% (4) \\\\\n\\hline Major vascular complications & 2.5\\% (3) & 2.5\\% (3) \\\\\n\\hline Life-threatening or disabling bleeding & 5.9\\% (7) & 7.8\\% (9) \\\\\n\\hline Major bleeding & 21.4\\% (25) & 23.3\\% (27) \\\\\n\\hline Acute kidney injury - Stage 2 or 3 & 3.4\\% (4) & 3.4\\% (4) \\\\\n\\hline Valve-related dysfunction requiring repeat procedure (surgical/interventional) & 0.0\\% (0) & 0.0\\% (0) \\\\\n\\hline New permanent pacemaker implantation resulting from new or worsened conduction disturbances & 32.2\\% (38) & 34.2\\% (40) \\\\\n\\hline Spontaneous MI (> 72 hours after index procedure) & 0.0\\% (0) & 0.0\\% (0) \\\\\n\\hline Hospitalization for valve-related symptoms or worsening congestive heart failure & 5.2\\% (6) & 8.0\\% (9) \\\\\n\\hline Atrial fibrillation or atrial flutter (new onset) & 6.0\\% (7) & 6.0\\% (7) \\\\\n\\hline Prosthetic aortic valve malpositioning & 0.0\\% (0) & 0.0\\% (0) \\\\\n\\hline Prosthetic aortic valve thrombosis & 0.0\\% (0) & 0.0\\% (0) \\\\\n\\hline Prosthetic aortic valve endocarditis 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Outcomes at 30 days","confidence":0.9917066079797223,"confidence_rate":0.9999300194779336},{"cnt":[[305,1401],[1815,1401],[1815,1450],[305,1450]],"region":{"top_left_x":305,"top_left_y":1400,"width":1511,"height":51},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0457c7155a474859ba14639b166d3ece","type":"text","conversion_output":true,"text":"in the full cohort were similar to that reported for the main cohort (see Table 4.1-2) with a","text_display":" in the full cohort were similar to that reported for the main cohort (see Table 4.1-2) with a","confidence":1,"confidence_rate":1},{"cnt":[[305,1448],[1777,1448],[1777,1497],[305,1497]],"region":{"top_left_x":305,"top_left_y":1448,"width":1472,"height":50},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f86dffeb7c1b432f9ad89eeabc8e6621","type":"text","conversion_output":true,"text":"mean aortic valve gradient of \\(11.70 \\pm 6.77 mmHg\\). Mortality was \\(4.4 \\%\\) and the disabling","text_display":" mean aortic valve gradient of \\(11.70 \\pm 6.77 mmHg\\). Mortality was \\(4.4 \\%\\) and the disabling","confidence":0.9990234375,"confidence_rate":0.9999899274770393},{"cnt":[[305,1497],[1742,1497],[1742,1545],[305,1545]],"region":{"top_left_x":305,"top_left_y":1497,"width":1438,"height":48},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"beac2a3bb0f14defa67ed5d63f4b5327","type":"text","conversion_output":true,"text":"stroke rate was \\(3.3 \\%\\). The new PPM implant rate was \\(29.6 \\%\\). Reported rates for early","text_display":" stroke rate was \\(3.3 \\%\\). The new PPM implant rate was \\(29.6 \\%\\). Reported rates for early","confidence":0.9150390625,"confidence_rate":0.9990658205821537},{"cnt":[[305,1543],[1848,1543],[1848,1592],[305,1592]],"region":{"top_left_x":305,"top_left_y":1542,"width":1543,"height":50},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e1a30a1538074fb29aa3c8090c15e7ad","type":"text","conversion_output":true,"text":"conduction abnormalities and the need for PPM implantation after TAVR have ranged from","text_display":" conduction abnormalities and the need for PPM implantation after TAVR have ranged from","confidence":1,"confidence_rate":1},{"cnt":[[305,1586],[1815,1586],[1815,1639],[305,1639]],"region":{"top_left_x":305,"top_left_y":1585,"width":1511,"height":55},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d87a3f743a674f8697b46f8024273d97","type":"text","conversion_output":true,"text":"\\(3 \\%\\) to \\(8 \\%\\) with SAPIEN and \\(14 \\%\\) to \\(40 \\%\\) with CoreValve \\({ }^{103}\\). In a recent report, 12 -month","text_display":" \\(3 \\%\\) to \\(8 \\%\\) with SAPIEN and \\(14 \\%\\) to \\(40 \\%\\) with CoreValve \\({ }^{103}\\). In a recent report, 12 -month","confidence":0.9882919762749225,"confidence_rate":0.9998948528288246},{"cnt":[[305,1633],[1785,1633],[1785,1691],[305,1691]],"region":{"top_left_x":305,"top_left_y":1632,"width":1481,"height":59},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9625ba1dda774c0bb49fdf527f7f810a","type":"text","conversion_output":true,"text":"clinical outcomes were similar among subjects with and without periprocedural PPM \\({ }^{104}\\).","text_display":" clinical outcomes were similar among subjects with and without periprocedural PPM \\({ }^{104}\\).","confidence":0.93798828125,"confidence_rate":0.9993725711963052},{"cnt":[[305,1689],[1850,1689],[1850,1738],[305,1738]],"region":{"top_left_x":305,"top_left_y":1688,"width":1545,"height":51},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"54c20b51e52d44eeab6a25cb5d064ab4","type":"text","conversion_output":true,"text":"Another study (mean follow-up of \\(22 \\pm 17\\) months) found that PPM implantation post TAVR","text_display":" Another study (mean follow-up of \\(22 \\pm 17\\) months) found that PPM implantation post TAVR","confidence":1,"confidence_rate":1},{"cnt":[[305,1736],[1850,1736],[1850,1785],[305,1785]],"region":{"top_left_x":305,"top_left_y":1735,"width":1545,"height":51},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2a9cd391985f44d0a0fc8671ac987980","type":"text","conversion_output":true,"text":"had a negative effect on left ventricular function but was not associated with any increase in","text_display":" had a negative effect on left ventricular function but was not associated with any increase in","confidence":1,"confidence_rate":1},{"cnt":[[305,1783],[1785,1783],[1785,1833],[305,1833]],"region":{"top_left_x":305,"top_left_y":1783,"width":1481,"height":50},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c6e689466e3442b887d69d0f738cfe98","type":"text","conversion_output":true,"text":"overall or cardiovascular death or rehospitalization for heart failure and was a protective","text_display":" overall or cardiovascular death or rehospitalization for heart failure and was a protective","confidence":1,"confidence_rate":1},{"cnt":[[305,1824],[1824,1824],[1824,1880],[305,1880]],"region":{"top_left_x":305,"top_left_y":1824,"width":1520,"height":56},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d19da62d054e4da89beb34731d3cef7d","type":"text","conversion_output":true,"text":"factor for the occurrence of sudden or unknown death \\((P=0.023)^{105}\\). Implantation of a new","text_display":" factor for the occurrence of sudden or unknown death \\((P=0.023)^{105}\\). Implantation of a new","confidence":0.99658203125,"confidence_rate":0.9999670791635416},{"cnt":[[305,1878],[1850,1878],[1850,1927],[305,1927]],"region":{"top_left_x":305,"top_left_y":1877,"width":1545,"height":51},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cfc0d9312b47401db585edc5905a21e2","type":"text","conversion_output":true,"text":"PPM following TAVR with SAPIEN (retrospective analysis from the combined PARTNER","text_display":" PPM following TAVR with SAPIEN (retrospective analysis from the combined PARTNER","confidence":1,"confidence_rate":1},{"cnt":[[305,1927],[1747,1927],[1747,1974],[305,1974]],"region":{"top_left_x":305,"top_left_y":1927,"width":1442,"height":48},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a73abbe2a75a4f0f87b6c79656a8b665","type":"text","conversion_output":true,"text":"trial and NRCA registry) was associated with a higher rate of repeat hospitalization at","text_display":" trial and NRCA registry) was associated with a higher rate of repeat hospitalization at","confidence":1,"confidence_rate":1},{"cnt":[[305,1972],[1852,1972],[1852,2022],[305,2022]],"region":{"top_left_x":305,"top_left_y":1972,"width":1547,"height":50},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0424e4a1caca4e1c84c0e32cecd49eda","type":"text","conversion_output":true,"text":"30 days and 1 year ( \\(10.6 \\%\\) vs. \\(5.9 \\%, P=0.02\\) at 30 days; \\(23.9 \\%\\) vs. \\(18.2 \\%, P=0.05\\) at 1 year)","text_display":" 30 days and 1 year ( \\(10.6 \\%\\) vs. \\(5.9 \\%, P=0.02\\) at 30 days; \\(23.9 \\%\\) vs. \\(18.2 \\%, P=0.05\\) at 1 year)","confidence":0.9990234375,"confidence_rate":0.9999913536688149},{"cnt":[[305,2015],[1852,2015],[1852,2073],[305,2073]],"region":{"top_left_x":305,"top_left_y":2015,"width":1547,"height":59},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"752b34cdb3b34c108aaec409bab6445c","type":"text","conversion_output":true,"text":"but not mortality ( \\(7.5 \\%\\) vs. \\(5.8 \\%, P=0.40\\) at 30 days; \\(26.3 \\%\\) vs. \\(20.8 \\%, P=0.08\\) at 1 year) \\({ }^{106}\\).","text_display":" but not mortality ( \\(7.5 \\%\\) vs. \\(5.8 \\%, P=0.40\\) at 30 days; \\(26.3 \\%\\) vs. \\(20.8 \\%, P=0.08\\) at 1 year) \\({ }^{106}\\).","confidence":0.5133600533008575,"confidence_rate":0.9946799791286322},{"cnt":[[305,2071],[1691,2071],[1691,2121],[305,2121]],"region":{"top_left_x":305,"top_left_y":2071,"width":1386,"height":50},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e8a7f23291ea438da9e950863fe2242a","type":"text","conversion_output":true,"text":"There was no severe paravalvular regurgitation and trace/trivial or no paravalvular","text_display":" There was no severe paravalvular regurgitation and trace/trivial or no paravalvular","confidence":1,"confidence_rate":1},{"cnt":[[305,2118],[1704,2118],[1704,2168],[305,2168]],"region":{"top_left_x":305,"top_left_y":2118,"width":1399,"height":50},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ae07a493fc12466bbcd6833600329ada","type":"text","conversion_output":true,"text":"regurgitation in \\(85.8 \\%\\) of REPRISE II subjects. Reported moderate or severe aortic","text_display":" regurgitation in \\(85.8 \\%\\) of REPRISE II subjects. Reported moderate or severe aortic","confidence":0.99462890625,"confidence_rate":0.999939489809101},{"cnt":[[305,2161],[1751,2161],[1751,2215],[305,2215]],"region":{"top_left_x":305,"top_left_y":2161,"width":1446,"height":55},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d009258df57044599708f2ee1a459989","type":"text","conversion_output":true,"text":"regurgitation after TAVR has ranged from \\(6 \\%\\) to \\(21 \\%^{107}\\) and has been associated with","text_display":" regurgitation after TAVR has ranged from \\(6 \\%\\) to \\(21 \\%^{107}\\) and has been associated with","confidence":0.99951171875,"confidence_rate":0.9999951160069457},{"cnt":[[305,2209],[1841,2209],[1841,2262],[305,2262]],"region":{"top_left_x":305,"top_left_y":2208,"width":1537,"height":55},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ba772cef9e2b41ad8a3d6b9f28342fbc","type":"text","conversion_output":true,"text":"increased mortality in several longitudinal registries \\({ }^{45,59,89,90}\\). Through 1 year, mortality was","text_display":" increased mortality in several longitudinal registries \\({ }^{45,59,89,90}\\). Through 1 year, mortality was","confidence":0.99267578125,"confidence_rate":0.9999366298309822},{"cnt":[[309,2262],[1871,2262],[1871,2312],[309,2312]],"region":{"top_left_x":309,"top_left_y":2262,"width":1563,"height":50},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"48213e9f9a18429582b4d5251778fe1e","type":"text","conversion_output":true,"text":"\\(12 \\%\\) and the disabling stroke rate was \\(3.6 \\%\\). Valve endocarditis ( \\(N =2\\) ) and thrombosis ( \\(N =3\\) )","text_display":" \\(12 \\%\\) and the disabling stroke rate was \\(3.6 \\%\\). Valve endocarditis ( \\(N =2\\) ) and thrombosis ( \\(N =3\\) )","confidence":0.9542839527130127,"confidence_rate":0.9995859794693857},{"cnt":[[305,2312],[1843,2312],[1843,2361],[305,2361]],"region":{"top_left_x":305,"top_left_y":2311,"width":1539,"height":51},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"747ae357875c42ffa2b02714e10f8410","type":"text","conversion_output":true,"text":"were successfully resolved with antibiotics and anticoagulant therapy, respectively, without","text_display":" were successfully resolved with antibiotics and anticoagulant therapy, respectively, without","confidence":1,"confidence_rate":1},{"cnt":[[305,2359],[1850,2359],[1850,2408],[305,2408]],"region":{"top_left_x":305,"top_left_y":2358,"width":1545,"height":51},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c7431f3e45594dbca8b98ffa490479eb","type":"text","conversion_output":true,"text":"sequelae. The low paravalvular aortic regurgitation rate observed at 30 days was maintained","text_display":" sequelae. The low paravalvular aortic regurgitation rate observed at 30 days was maintained","confidence":1,"confidence_rate":1},{"cnt":[[305,2408],[1841,2408],[1841,2456],[305,2456]],"region":{"top_left_x":305,"top_left_y":2408,"width":1537,"height":48},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d91cdd094a824e01821eb2bcb4941f17","type":"text","conversion_output":true,"text":"at 1 year as most subjects ( \\(85 \\%\\) ) had none/trivial paravalvular aortic regurgitation and there","text_display":" at 1 year as most subjects ( \\(85 \\%\\) ) had none/trivial paravalvular aortic regurgitation and there","confidence":0.9092237949371338,"confidence_rate":0.9991026291418907},{"cnt":[[305,2454],[1214,2454],[1214,2503],[305,2503]],"region":{"top_left_x":305,"top_left_y":2453,"width":909,"height":50},"line":48,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d5d1d41de7a14b99a125b941d3f2f5de","type":"text","conversion_output":true,"text":"was no moderate or severe paravalvular regurgitation.","text_display":" was no moderate or severe paravalvular regurgitation.","confidence":1,"confidence_rate":1},{"cnt":[[103,2651],[312,2651],[312,2692],[103,2692]],"region":{"top_left_x":103,"top_left_y":2651,"width":209,"height":41},"line":49,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a96ce9d3afdd4d40a580b0d1a79ab11c","type":"page_info","conversion_output":false,"text":"Released","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[829,2655],[1291,2655],[1291,2692],[829,2692]],"region":{"top_left_x":829,"top_left_y":2655,"width":463,"height":37},"line":50,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"076f1745d30d4a32bc786b3de579ea9d","type":"page_info","conversion_output":false,"text":"REPRISE III Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1654,2651],[1983,2651],[1983,2688],[1654,2688]],"region":{"top_left_x":1654,"top_left_y":2651,"width":330,"height":37},"line":51,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"329df3b57e434b4e8406f77e0593476d","type":"page_info","conversion_output":false,"text":"90899936 AK. 4","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[486,2690],[2000,2690],[2000,2731],[486,2731]],"region":{"top_left_x":485,"top_left_y":2689,"width":1516,"height":42},"line":52,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"44db5ad05008450b8d24bd4276739e2a","type":"page_info","conversion_output":false,"text":"Boston Scientific Confidential. 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The results of the REPRISE II study support the safety and performance","text_display":" PVR rates are lower. The results of the REPRISE II study support the safety and performance","confidence":1,"confidence_rate":1},{"cnt":[[309,464],[767,464],[767,509],[309,509]],"region":{"top_left_x":309,"top_left_y":464,"width":458,"height":46},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"18ee659229864b499afc73911f48151f","type":"text","conversion_output":true,"text":"of the Lotus Valve System.","text_display":" of the Lotus Valve System.","confidence":1,"confidence_rate":1},{"cnt":[[357,541],[1830,541],[1830,591],[357,591]],"region":{"top_left_x":356,"top_left_y":541,"width":1475,"height":50},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e3cdf0c986024977aa6d182487bb7749","type":"figure_label","conversion_output":false,"text":"Table 4.1-4: 30-Day and 1-Year Outcomes in the REPRISE II Full Cohort ( \\(N = 2 5 0\\) 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Outcomes & REPRISE II (30 Days) & REPRISE II (1 Year) \\\\\n\\hline \\multicolumn{3}{|l|}{Clinical Outcomes at 30 Days and 1 Year (CEC Adjudicated)} \\\\\n\\hline All-cause mortality & 4.4\\% (11/249) & 11.6\\% (29/249) \\\\\n\\hline Cardiovascular & 4.0\\% (10/249) & 7.6\\% (19/249) \\\\\n\\hline All stroke & 7.1\\% (17/241) & 8.4\\% (21/249) \\\\\n\\hline Disabling stroke & 3.3\\% (8/241) & 3.6\\% (9/249) \\\\\n\\hline Major vascular complications & 5.4\\% (13/241) & 5.2\\% (13/249) \\\\\n\\hline Life-threatening or disabling bleeding & 7.3\\% (18/247) & 9.2\\% (23/249) \\\\\n\\hline Major bleeding & 21.5\\% (53/247) & 23.3\\% (58/249) \\\\\n\\hline Acute kidney injury - Stage 2 or 3 & 2.9\\% (7/240) & 2.9\\% (7/240) \\\\\n\\hline Coronary obstruction (periprocedural) & 0.8\\% (2/241) & - \\\\\n\\hline Valve-related dysfunction requiring repeat procedure (surgical/interventional) & 0.0\\% (0/240) & 0.0\\% (0/249) \\\\\n\\hline New permanent pacemaker implantation resulting from new or worsened conduction disturbances & 29.6\\% (72/243) & 32.5\\% (81/249) \\\\\n\\hline Periprocedural MI ( \\(\\leq 72\\) hours after index procedure) & 2.9\\% (7/243) & - \\\\\n\\hline Spontaneous MI (>72 hours after index procedure) & - & 0.0\\% (0/249) \\\\\n\\hline Hospitalization for valve-related symptoms or worsening congestive heart failure & 2.9\\% (7/240) & 6.8\\% (17/249) \\\\\n\\hline Atrial fibrillation or atrial flutter (new onset) & 6.6\\% (16/241) & 6.8\\% (17/249) \\\\\n\\hline Ventricular septal perforation (periprocedural) & 0.0\\% (0/240) & - \\\\\n\\hline Mitral apparatus damage (periprocedural) & 1.7\\% (4/240) & - \\\\\n\\hline Cardiac tamponade (periprocedural) & 3.7\\% (9/246) & - \\\\\n\\hline Prosthetic aortic valve malpositioning & 0.0\\% (0/240) & 0.0\\% (0/249) \\\\\n\\hline Prosthetic aortic valve thrombosis & 0.0\\% (0/240) & 1.2\\% (3/249) \\\\\n\\hline Prosthetic aortic valve endocarditis & 0.0\\% (0/240) & 0.8\\% (2/249) \\\\\n\\hline \\multicolumn{3}{|l|}{Device Performance Endpoints} \\\\\n\\hline Successful vascular access, delivery, and deployment of the Lotus Valve System, and successful retrieval of the delivery system & 98.8\\% (247/250) & - \\\\\n\\hline Successful repositioning (partial or complete resheathing of the Lotus Valve in the catheter and redeployment in a more accurate position within the aortic valve annulus) of the Lotus Valve System if repositioning is attempted for the last valve attempted & 100.0\\% (85/85) & - \\\\\n\\hline Successful retrieval (complete resheathing of the Lotus Valve in the catheter and removal from the body) of the Lotus Valve System if retrieval is attempted & 92.3\\% (12/13) & - \\\\\n\\hline \\multicolumn{3}{|l|}{Valve Performance by Transthoracic Echocardiography (30 Days-Core Lab Assessment)} \\\\\n\\hline Aortic valve area (effective orifice area) (cm) & \\(1.74 \\pm 0.45(149)\\) & \\(1.68 \\pm 0.49(157)\\) \\\\\n\\hline Mean aortic valve gradient (mmHg) & \\(11.70 \\pm 6.77\\) (183) & \\(12.49 \\pm 5.35\\) (176) \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Table 4.1-4: 30-Day and 1-Year Outcomes in the REPRISE II Full Cohort ( \\(N = 2 5 0\\) )}\n\\begin{tabular}{|l|l|l|}\n\\hline Outcomes & REPRISE II (30 Days) & REPRISE II (1 Year) \\\\\n\\hline \\multicolumn{3}{|l|}{Clinical Outcomes at 30 Days and 1 Year (CEC Adjudicated)} \\\\\n\\hline All-cause mortality & 4.4\\% (11/249) & 11.6\\% (29/249) \\\\\n\\hline Cardiovascular & 4.0\\% (10/249) & 7.6\\% (19/249) \\\\\n\\hline All stroke & 7.1\\% (17/241) & 8.4\\% (21/249) \\\\\n\\hline Disabling stroke & 3.3\\% (8/241) & 3.6\\% (9/249) \\\\\n\\hline Major vascular complications & 5.4\\% (13/241) & 5.2\\% (13/249) \\\\\n\\hline Life-threatening or disabling bleeding & 7.3\\% (18/247) & 9.2\\% (23/249) \\\\\n\\hline Major bleeding & 21.5\\% (53/247) & 23.3\\% (58/249) \\\\\n\\hline Acute kidney injury - Stage 2 or 3 & 2.9\\% (7/240) & 2.9\\% (7/240) \\\\\n\\hline Coronary obstruction (periprocedural) & 0.8\\% (2/241) & - \\\\\n\\hline Valve-related dysfunction requiring repeat procedure (surgical/interventional) & 0.0\\% (0/240) & 0.0\\% (0/249) \\\\\n\\hline New permanent pacemaker implantation resulting from new or worsened conduction disturbances & 29.6\\% (72/243) & 32.5\\% (81/249) \\\\\n\\hline Periprocedural MI ( \\(\\leq 72\\) hours after index procedure) & 2.9\\% (7/243) & - \\\\\n\\hline Spontaneous MI (>72 hours after index procedure) & - & 0.0\\% (0/249) \\\\\n\\hline Hospitalization for valve-related symptoms or worsening congestive heart failure & 2.9\\% (7/240) & 6.8\\% (17/249) \\\\\n\\hline Atrial fibrillation or atrial flutter (new onset) & 6.6\\% (16/241) & 6.8\\% (17/249) \\\\\n\\hline Ventricular septal perforation (periprocedural) & 0.0\\% (0/240) & - \\\\\n\\hline Mitral apparatus damage (periprocedural) & 1.7\\% (4/240) & - \\\\\n\\hline Cardiac tamponade (periprocedural) & 3.7\\% (9/246) & - \\\\\n\\hline Prosthetic aortic valve malpositioning & 0.0\\% (0/240) & 0.0\\% (0/249) \\\\\n\\hline Prosthetic aortic valve thrombosis & 0.0\\% (0/240) & 1.2\\% (3/249) \\\\\n\\hline Prosthetic aortic valve endocarditis & 0.0\\% (0/240) & 0.8\\% (2/249) \\\\\n\\hline \\multicolumn{3}{|l|}{Device Performance Endpoints} \\\\\n\\hline Successful vascular access, delivery, and deployment of the Lotus Valve System, and successful retrieval of the delivery system & 98.8\\% (247/250) & - \\\\\n\\hline Successful repositioning (partial or complete resheathing of the Lotus Valve in the catheter and redeployment in a more accurate position within the aortic valve annulus) of the Lotus Valve System if repositioning is attempted for the last valve attempted & 100.0\\% (85/85) & - \\\\\n\\hline Successful retrieval (complete resheathing of the Lotus Valve in the catheter and removal from the body) of the Lotus Valve System if retrieval is attempted & 92.3\\% (12/13) & - \\\\\n\\hline 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days post-procedure or who were event-free with last follow-up at least 23 days","text_display":" either had an event within 30 days post-procedure or who were event-free with last follow-up at least 23 days","confidence":1,"confidence_rate":1},{"cnt":[[309,1040],[1416,1040],[1416,1085],[309,1085]],"region":{"top_left_x":309,"top_left_y":1039,"width":1107,"height":46},"line":54,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8af83086e151475b901668e79bdde981","type":"text","conversion_output":true,"text":"post-procedure. Outcomes at 1 year are based on the as-treated group ( \\(N =249\\) ).","text_display":" post-procedure. 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REPRISE NG DS Study","text_display":"\n\n\\subsection*{4.1.4. REPRISE NG DS Study}","confidence":1,"confidence_rate":1},{"cnt":[[305,1259],[1841,1259],[1841,1308],[305,1308]],"region":{"top_left_x":305,"top_left_y":1258,"width":1537,"height":51},"line":58,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b06e0a6de5f64f51ac872969a2deaa2e","type":"text","conversion_output":true,"text":"The LOTUS Edge Valve System with a modified iteration of the delivery system studied in","text_display":"\n\nThe LOTUS Edge Valve System with a modified iteration of the delivery system studied in","confidence":1,"confidence_rate":1},{"cnt":[[305,1306],[1876,1306],[1876,1356],[305,1356]],"region":{"top_left_x":305,"top_left_y":1306,"width":1571,"height":50},"line":59,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cd17206de4e744e485210de604d547d3","type":"text","conversion_output":true,"text":"REPRISE I and REPRISE II was evaluated in the REpositionable Percutaneous Replacement","text_display":" REPRISE I and REPRISE II was evaluated in the REpositionable Percutaneous Replacement","confidence":0.9965834617614746,"confidence_rate":0.9999619741904117},{"cnt":[[305,1354],[1798,1354],[1798,1403],[305,1403]],"region":{"top_left_x":305,"top_left_y":1353,"width":1494,"height":50},"line":60,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"be0d1de8d6ac4287ad62a30ba46fbb52","type":"text","conversion_output":true,"text":"of Stenotic Aortic Valve through Implantation of LotuS Valv \\(\\underline{E}\\) with the Next Generation","text_display":" of Stenotic Aortic Valve through Implantation of LotuS Valv \\(\\underline{E}\\) with the Next Generation","confidence":0.7727294609440768,"confidence_rate":0.9973455265011086},{"cnt":[[305,1403],[1861,1403],[1861,1452],[305,1452]],"region":{"top_left_x":305,"top_left_y":1402,"width":1556,"height":51},"line":61,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7766b8f1959b45c8bd219a91aec4c41f","type":"text","conversion_output":true,"text":"Delivery System (REPRISE NG DS) first-human-use trial. Acute performance and safety of","text_display":" Delivery System (REPRISE NG DS) first-human-use trial. Acute performance and safety of","confidence":1,"confidence_rate":1},{"cnt":[[305,1501],[305,1450],[1852,1452],[1852,1503]],"region":{"top_left_x":305,"top_left_y":1450,"width":1548,"height":54},"line":62,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"737fa5b081884d1289585c3ee12afac6","type":"text","conversion_output":true,"text":"iterative designs have been evaluated in three cohorts: Cohort A, Cohort B and Cohort C. In","text_display":" iterative designs have been evaluated in three cohorts: Cohort A, Cohort B and Cohort C. In","confidence":0.901228666305542,"confidence_rate":0.998917292156849},{"cnt":[[307,1500],[1824,1500],[1824,1549],[307,1549]],"region":{"top_left_x":307,"top_left_y":1499,"width":1518,"height":51},"line":63,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6ebbba6b3d4142b8bb85a98bd87a28eb","type":"text","conversion_output":true,"text":"Cohort A of this prospective single-arm study, 10 subjects were enrolled at 2 investigative","text_display":" Cohort A of this prospective single-arm study, 10 subjects were enrolled at 2 investigative","confidence":0.99951171875,"confidence_rate":0.999995211771286},{"cnt":[[305,1547],[1850,1547],[1850,1596],[305,1596]],"region":{"top_left_x":305,"top_left_y":1546,"width":1545,"height":51},"line":64,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"55db1a5ee6634bb18f43e20a5c567225","type":"text","conversion_output":true,"text":"centers in Australia; the device was introduced into the body using the Lotus Introducer Set.","text_display":" centers in Australia; the device was introduced into the body using the Lotus Introducer Set.","confidence":1,"confidence_rate":1},{"cnt":[[305,1594],[1783,1594],[1783,1644],[305,1644]],"region":{"top_left_x":305,"top_left_y":1594,"width":1479,"height":50},"line":65,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c857c1c13ab5418c9441efa07332f900","type":"text","conversion_output":true,"text":"In Cohort B, an additional 7 subjects were enrolled at the same centers to evaluate acute","text_display":" In Cohort B, an additional 7 subjects were enrolled at the same centers to evaluate acute","confidence":0.99951171875,"confidence_rate":0.9999949649559944},{"cnt":[[305,1641],[1863,1641],[1863,1693],[305,1693]],"region":{"top_left_x":305,"top_left_y":1641,"width":1558,"height":52},"line":66,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"38a02591bcda41bc8ea43043519b6d45","type":"text","conversion_output":true,"text":"performance and safety of a further optimized version of the LOTUS Edge device (including","text_display":" performance and safety of a further optimized version of the LOTUS Edge device (including","confidence":1,"confidence_rate":1},{"cnt":[[305,1691],[1738,1691],[1738,1740],[305,1740]],"region":{"top_left_x":305,"top_left_y":1690,"width":1434,"height":51},"line":67,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"92e8bf221bd441878ccb7e59c1584da7","type":"text","conversion_output":true,"text":"radiopaque markers on the valve locking assembly). Cohort B also assessed the acute","text_display":" radiopaque markers on the valve locking assembly). Cohort B also assessed the acute","confidence":0.9669113159179688,"confidence_rate":0.9996177037953689},{"cnt":[[305,1738],[1654,1738],[1654,1790],[305,1790]],"region":{"top_left_x":305,"top_left_y":1738,"width":1350,"height":52},"line":68,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6f8cb2336f904cb1b0583c5187983793","type":"text","conversion_output":true,"text":"performance and safety of an early iteration of the iSleeve Introducer Set and its","text_display":" performance and safety of an early iteration of the iSleeve Introducer Set and its","confidence":1,"confidence_rate":1},{"cnt":[[305,1783],[1828,1783],[1828,1835],[305,1835]],"region":{"top_left_x":305,"top_left_y":1783,"width":1524,"height":52},"line":69,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1b3c79d9025a470fb50c6c630322cd8b","type":"text","conversion_output":true,"text":"compatibility with the LOTUS Edge device. Cohort C completed enrollment in September","text_display":" compatibility with the LOTUS Edge device. Cohort C completed enrollment in September","confidence":0.99365234375,"confidence_rate":0.9999284532530434},{"cnt":[[305,1833],[1854,1833],[1854,1884],[305,1884]],"region":{"top_left_x":305,"top_left_y":1832,"width":1550,"height":53},"line":70,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"93930643e78c4792845fa10dc4e33e0d","type":"text","conversion_output":true,"text":"2016 with 21 subjects treated with the LOTUS Edge Valve System, which features a further","text_display":" 2016 with 21 subjects treated with the LOTUS Edge Valve System, which features a further","confidence":1,"confidence_rate":1},{"cnt":[[305,1882],[1869,1882],[1869,1931],[305,1931]],"region":{"top_left_x":305,"top_left_y":1882,"width":1565,"height":50},"line":71,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"71a0a840896f40c4ad7c5b6d546502dd","type":"text","conversion_output":true,"text":"refined version of the delivery system, implanted with either the Lotus or expandable iSleeve","text_display":" refined version of the delivery system, implanted with either the Lotus or expandable iSleeve","confidence":0.99951171875,"confidence_rate":0.9999950163338663},{"cnt":[[305,1929],[1798,1929],[1798,1979],[305,1979]],"region":{"top_left_x":305,"top_left_y":1929,"width":1494,"height":50},"line":72,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"33d159c8e3054f33965420fc4658684a","type":"text","conversion_output":true,"text":"Introducer. Device sizes evaluated included the \\(23 mm, 25 mm\\) and 27 mm . The primary","text_display":" Introducer. Device sizes evaluated included the \\(23 mm, 25 mm\\) and 27 mm . The primary","confidence":0.99951171875,"confidence_rate":0.9999951160069457},{"cnt":[[305,1977],[1837,1977],[1837,2030],[305,2030]],"region":{"top_left_x":305,"top_left_y":1976,"width":1532,"height":55},"line":73,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8b7c58d937714c1d85aa1e3d73de5655","type":"text","conversion_output":true,"text":"endpoint of the study was technical success, defined as follows: successful vascular access,","text_display":" endpoint of the study was technical success, defined as follows: successful vascular access,","confidence":1,"confidence_rate":1},{"cnt":[[305,2024],[1833,2024],[1833,2075],[305,2075]],"region":{"top_left_x":305,"top_left_y":2023,"width":1528,"height":53},"line":74,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4bc00d92747d4ec1919d2a04e377e2fb","type":"text","conversion_output":true,"text":"delivery and deployment of the Lotus valve and successful retrieval with the LOTUS Edge","text_display":" delivery and deployment of the Lotus valve and successful retrieval with the LOTUS Edge","confidence":1,"confidence_rate":1},{"cnt":[[305,2073],[1871,2073],[1871,2125],[305,2125]],"region":{"top_left_x":305,"top_left_y":2073,"width":1567,"height":52},"line":75,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f8e5474adcaf4431911fee1dba671648","type":"text","conversion_output":true,"text":"delivery system; correct positioning of the Lotus valve in the proper anatomical location; and","text_display":" delivery system; correct positioning of the Lotus valve in the proper anatomical location; and","confidence":0.998046875,"confidence_rate":0.9999802523683627},{"cnt":[[305,2123],[1772,2123],[1772,2172],[305,2172]],"region":{"top_left_x":305,"top_left_y":2122,"width":1468,"height":51},"line":76,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1ed2782c506e4d1abfddc8d147531154","type":"text","conversion_output":true,"text":"only one Lotus valve implanted in the proper anatomical location. Other measurements","text_display":" only one Lotus valve implanted in the proper anatomical location. Other measurements","confidence":1,"confidence_rate":1},{"cnt":[[305,2161],[1850,2161],[1850,2219],[305,2219]],"region":{"top_left_x":305,"top_left_y":2161,"width":1545,"height":59},"line":77,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c6832abe83114889b0caf11542a642b0","type":"text","conversion_output":true,"text":"incorporated data collection and endpoints recommended and defined by the VARC \\(1{ }^{72}\\) and","text_display":" incorporated data collection and endpoints recommended and defined by the VARC \\(1{ }^{72}\\) and","confidence":0.6143334461376071,"confidence_rate":0.9951876815730096},{"cnt":[[305,2213],[1463,2213],[1463,2271],[305,2271]],"region":{"top_left_x":305,"top_left_y":2212,"width":1159,"height":59},"line":78,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"80ca691e62094e0a907a915631726978","type":"text","conversion_output":true,"text":"VARC \\(2^{73}\\) guidelines. Clinical follow-up will extend through 1 year.","text_display":" VARC \\(2^{73}\\) guidelines. Clinical follow-up will extend through 1 year.","confidence":0.935546875,"confidence_rate":0.9992164950107063},{"cnt":[[305,2277],[1854,2277],[1854,2340],[305,2340]],"region":{"top_left_x":305,"top_left_y":2277,"width":1550,"height":63},"line":79,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"739a6365fb324efe869ff762d4b1d0f6","type":"text","conversion_output":true,"text":"The primary endpoint was achieved in \\(10 / 10\\) subjects in Cohort \\(A ^{108}\\) and \\(5 / 7\\) in Cohort B (in","text_display":"\nThe primary endpoint was achieved in \\(10 / 10\\) subjects in Cohort \\(A ^{108}\\) and \\(5 / 7\\) in Cohort B (in","confidence":0.5069937464868076,"confidence_rate":0.9940593246956104},{"cnt":[[309,2333],[1858,2333],[1858,2385],[309,2385]],"region":{"top_left_x":309,"top_left_y":2333,"width":1550,"height":52},"line":80,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"097ccd2182524b549829f3b83e739f8d","type":"text","conversion_output":true,"text":"1 subject a valve was not implanted and in 1 subject a valve was implanted using the current","text_display":" 1 subject a valve was not implanted and in 1 subject a valve was implanted using the current","confidence":1,"confidence_rate":1},{"cnt":[[305,2380],[1880,2380],[1880,2432],[305,2432]],"region":{"top_left_x":305,"top_left_y":2380,"width":1575,"height":53},"line":81,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2b5b28b43ca9498bbd277d7265ec6f6f","type":"text","conversion_output":true,"text":"Lotus Valve System). 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There were no cases of","text_display":"\nimproved at discharge, and remained improved at 30 days and 1 year. There were no cases of","confidence":1,"confidence_rate":1},{"cnt":[[309,417],[1828,417],[1828,462],[309,462]],"region":{"top_left_x":309,"top_left_y":416,"width":1520,"height":46},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ec61a7b0d80c45448317be9e3f238aed","type":"text","conversion_output":true,"text":"moderate or severe PVR at discharge, 30 days or 1-year in either cohort. Table 4.1-6 shows","text_display":" moderate or severe PVR at discharge, 30 days or 1-year in either cohort. Table 4.1-6 shows","confidence":0.6359329223632812,"confidence_rate":0.9953916492533532},{"cnt":[[309,464],[1729,464],[1729,509],[309,509]],"region":{"top_left_x":309,"top_left_y":464,"width":1421,"height":46},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3ce0ec83daf74d3a8902562eeb85f440","type":"text","conversion_output":true,"text":"rates of CEC-adjudicated VARC-defined events during the index procedure, through","text_display":" rates of CEC-adjudicated VARC-defined events during the index procedure, through","confidence":1,"confidence_rate":1},{"cnt":[[309,511],[1833,511],[1833,559],[309,559]],"region":{"top_left_x":309,"top_left_y":511,"width":1524,"height":48},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0fe96b48b0da4471b6d163e4950e1cc3","type":"text","conversion_output":true,"text":"discharge/7 days, 30 days and 1 year. In Cohort A, one subject experienced the majority of","text_display":" discharge/7 days, 30 days and 1 year. In Cohort A, one subject experienced the majority of","confidence":0.6853652000427246,"confidence_rate":0.9962663592755258},{"cnt":[[309,559],[1833,559],[1833,606],[309,606]],"region":{"top_left_x":309,"top_left_y":558,"width":1524,"height":48},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9acd15f6ef2749c89d9822528e0b8416","type":"text","conversion_output":true,"text":"events and subsequently died on day 13 post implant. Another subject died on day 119; the","text_display":" events and subsequently died on day 13 post implant. Another subject died on day 119; the","confidence":0.92822265625,"confidence_rate":0.9992324221235664},{"cnt":[[309,608],[1867,608],[1867,655],[309,655]],"region":{"top_left_x":309,"top_left_y":608,"width":1558,"height":48},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f1b7f4b533eb42c381300d1525c57c6d","type":"text","conversion_output":true,"text":"primary cause of death was multiorgan failure, which was not considered related to the index","text_display":" primary cause of death was multiorgan failure, which was not considered related to the index","confidence":1,"confidence_rate":1},{"cnt":[[309,657],[1858,657],[1858,703],[309,703]],"region":{"top_left_x":309,"top_left_y":657,"width":1550,"height":46},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ed9bcf65349b42c8be30d95d94f3ddb3","type":"text","conversion_output":true,"text":"procedure. In Cohort B, events were minimal through 1 year post implant. Acute and 30 -day","text_display":" procedure. In Cohort B, events were minimal through 1 year post implant. Acute and 30 -day","confidence":0.9834136962890625,"confidence_rate":0.999834415724293},{"cnt":[[309,705],[1807,705],[1807,750],[309,750]],"region":{"top_left_x":309,"top_left_y":704,"width":1498,"height":46},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e4b6a9c78db44b6d8423e45e426534a8","type":"text","conversion_output":true,"text":"outcomes were sustained through 1 year in both cohorts. Overall, the results in Cohorts A","text_display":" outcomes were sustained through 1 year in both cohorts. Overall, the results in Cohorts A","confidence":0.9990234375,"confidence_rate":0.9999899274770393},{"cnt":[[309,752],[1841,752],[1841,797],[309,797]],"region":{"top_left_x":309,"top_left_y":751,"width":1533,"height":47},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"776f29a9d501423d930b27860a87e2e7","type":"text","conversion_output":true,"text":"and B of the REPRISE NG DS study demonstrate acceptable performance and safety of the","text_display":" and B of the REPRISE NG DS study demonstrate acceptable performance and safety of the","confidence":0.9980475902557373,"confidence_rate":0.99997828558931},{"cnt":[[309,799],[690,799],[690,844],[309,844]],"region":{"top_left_x":309,"top_left_y":799,"width":381,"height":46},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"85d2a8d00a7a45278489fa49bc9cfacb","type":"text","conversion_output":true,"text":"LOTUS Edge System.","text_display":" LOTUS Edge 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\\multirow{2}{*}{Measure} & \\multicolumn{3}{|c|}{Cohort A} & \\multicolumn{3}{|c|}{Cohort B} \\\\\n\\hline & Discharge & 30 Days & 1 Year & Discharge & 30 Days & 1 Year \\\\\n\\hline Aortic valve area (effective orifice area) ( \\(cm ^{2}\\) ) & \\(1.55 \\pm 0.43\\) (10) & \\(1.44 \\pm 0.45\\) (9) & \\(1.38 \\pm 0.49\\) (6) & \\(1.84 \\pm 0.38\\) (3) & \\(1.32 \\pm 0.48\\) (4) & \\(1.40 \\pm 0.32\\) (5) \\\\\n\\hline Mean aortic valve gradient (mmHg) & \\(13.42 \\pm 4.30\\) (10) & \\(15.72 \\pm 8.04\\) (9) & \\(15.80 \\pm 9.20\\) (6) & \\(9.80 \\pm 4.28\\) (5) & \\(10.28 \\pm 0.75\\) (4) & \\(12.86 \\pm 1.98\\) (5) \\\\\n\\hline \\multicolumn{7}{|l|}{Paravalvular Aortic Regurgitation} \\\\\n\\hline None & 80.0\\% (8/10) & 66.7\\% (6/9) & 66.7\\% (4/6) & 80.0\\% (4/5) & 50.0\\% (2/4) & 100.0\\% (5/5) \\\\\n\\hline Trace/Trivial & 10.0\\% (1/10) & 11.1\\% (1/9) & 33.3\\% (2/6) & 20.0\\% (1/5) & 50.0\\% (2/4) & 0.0\\% (0/5) \\\\\n\\hline Mild & 10.0\\% (1/10) & 11.1\\% (1/9) & 0.0\\% (0/6) & 0.0\\% (0/5) & 0.0\\% (0/4) & 0.0\\% (0/5) \\\\\n\\hline Moderate & 0.0\\% (0/10) & 0.0\\% (0/9) & 0.0\\% (0/6) & 0.0\\% (0/5) & 0.0\\% (0/4) & 0.0\\% (0/5) \\\\\n\\hline Severe & 0.0\\% (0/10) & 0.0\\% (0/9) & 0.0\\% (0/6) & 0.0\\% (0/5) & 0.0\\% (0/4) & 0.0\\% (0/5) \\\\\n\\hline Regurgitation, but severity not evaluable & 0.0\\% (0/10) & 11.1\\% (1/9) & 0.0\\% (0/6) & 0.0\\% (0/5) & 0.0\\% (0/4) & 0.0\\% (0/5) \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Table 4.1-5: Echocardiographic Outcomes in REPRISE NG DS Cohorts A and B}\n\\begin{tabular}{|l|l|l|l|l|l|l|}\n\\hline \\multirow{2}{*}{Measure} & \\multicolumn{3}{|c|}{Cohort A} & \\multicolumn{3}{|c|}{Cohort B} \\\\\n\\hline & Discharge & 30 Days & 1 Year & Discharge & 30 Days & 1 Year \\\\\n\\hline Aortic valve area (effective orifice area) ( \\(cm ^{2}\\) ) & \\(1.55 \\pm 0.43\\) (10) & \\(1.44 \\pm 0.45\\) (9) & \\(1.38 \\pm 0.49\\) (6) & \\(1.84 \\pm 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Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1482,223],[1880,223],[1880,264],[1482,264]],"region":{"top_left_x":1482,"top_left_y":223,"width":398,"height":42},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d5fb7322bc4d4f39bd0b17c0c57b130a","type":"page_info","conversion_output":false,"text":"90899936 Rev/Ver AK","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999787654211912},{"cnt":[[1620,271],[1880,271],[1880,320],[1620,320]],"region":{"top_left_x":1619,"top_left_y":270,"width":261,"height":51},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"098deb7146d64d3689806cfdc6bdff0e","type":"page_info","conversion_output":false,"text":"Page 39 of 188","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[490,378],[1732,378],[1732,419],[490,419]],"region":{"top_left_x":489,"top_left_y":378,"width":1243,"height":41},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ce2db439e16f4b14af9e847ca073dcf7","type":"figure_label","conversion_output":false,"text":"Table 4.1-6: Clinical Outcomes in REPRISE NG DS Cohorts A and 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}\n\\hline \\multirow{2}{*}{VARC Event} & \\multicolumn{3}{|c|}{Cohort A ( \\(N = 1 0\\) )} & \\multicolumn{3}{|c|}{Cohort B ( \\(N = 7\\) )} \\\\\n\\hline & Discharge & 30 Days & 1 Year & Discharge & 30 Days & 1 Year \\\\\n\\hline New PPM & \\begin{tabular}{l}\n0.0\\% \\\\\n(0/10)\n\\end{tabular} & \\begin{tabular}{l}\n30.0\\% \\\\\n(3/10)\n\\end{tabular} & \\begin{tabular}{l}\n40.0\\% \\\\\n(4/10)\n\\end{tabular} & 0.0\\% (0/7) & \\begin{tabular}{l}\n0.0\\% \\\\\n(0/5)\n\\end{tabular} & \\begin{tabular}{l}\n0.0\\% \\\\\n(0/6)\n\\end{tabular} \\\\\n\\hline Life-threatening/disabling bleeding & \\begin{tabular}{l}\n20.0\\% \\\\\n(2/10)\n\\end{tabular} & \\begin{tabular}{l}\n20.0\\% \\\\\n(2/10)\n\\end{tabular} & \\begin{tabular}{l}\n20.0\\% \\\\\n(2/10)\n\\end{tabular} & 0.0\\% (0/7) & \\begin{tabular}{l}\n0.0\\% \\\\\n(0/5)\n\\end{tabular} & \\begin{tabular}{l}\n0.0\\% \\\\\n(0/6)\n\\end{tabular} \\\\\n\\hline Myocardial infarction & \\begin{tabular}{l}\n0.0\\% \\\\\n(0/10)\n\\end{tabular} & \\begin{tabular}{l}\n0.0\\% \\\\\n(0/10)\n\\end{tabular} & \\begin{tabular}{l}\n0.0\\% \\\\\n(0/10)\n\\end{tabular} & 0.0\\% (0/7) & \\begin{tabular}{l}\n0.0\\% \\\\\n(0/5)\n\\end{tabular} & 0.0\\% (0/6) \\\\\n\\hline Acute kidney injury - Stage 2/3 & \\begin{tabular}{l}\n10.0\\% \\\\\n(1/10)\n\\end{tabular} & \\begin{tabular}{l}\n10.0\\% \\\\\n(1/10)\n\\end{tabular} & \\begin{tabular}{l}\n10.0\\% \\\\\n(1/10)\n\\end{tabular} & 0.0\\% (0/7) & \\begin{tabular}{l}\n0.0\\% \\\\\n(0/5)\n\\end{tabular} & 0.0\\% (0/6) \\\\\n\\hline Repeat procedure for valve-related dysfunction (surgical/interventional) & \\begin{tabular}{l}\n0.0\\% \\\\\n(0/10)\n\\end{tabular} & \\begin{tabular}{l}\n0.0\\% \\\\\n(0/10)\n\\end{tabular} & \\begin{tabular}{l}\n0.0\\% \\\\\n(0/10)\n\\end{tabular} & 0.0\\% (0/7) & \\begin{tabular}{l}\n0.0\\% \\\\\n(0/5)\n\\end{tabular} & 0.0\\% (0/6) \\\\\n\\hline Hospitalization for valve-related symptoms or worsening CHF & \\begin{tabular}{l}\n0.0\\% \\\\\n(0/10)\n\\end{tabular} & \\begin{tabular}{l}\n0.0\\% \\\\\n(0/10)\n\\end{tabular} & \\begin{tabular}{l}\n0.0\\% \\\\\n(0/10)\n\\end{tabular} & 0.0\\% (0/7) & \\begin{tabular}{l}\n0.0\\% \\\\\n(0/5)\n\\end{tabular} & 16.7\\% (1/6) \\\\\n\\hline New onset atrial fibrillation/flutter & \\begin{tabular}{l}\n0.0\\% \\\\\n(0/10)\n\\end{tabular} & \\begin{tabular}{l}\n0.0\\% \\\\\n(0/10)\n\\end{tabular} & \\begin{tabular}{l}\n0.0\\% \\\\\n(0/10)\n\\end{tabular} & 0.0\\% (0/7) & \\begin{tabular}{l}\n0.0\\% \\\\\n(0/5)\n\\end{tabular} & 0.0\\% (0/6) \\\\\n\\hline Coronary obstruction (periprocedural) & \\begin{tabular}{l}\n0.0\\% \\\\\n(0/10)\n\\end{tabular} & N/A & \\begin{tabular}{l}\n0.0\\% \\\\\n(0/10)\n\\end{tabular} & 0.0\\% (0/7) & N/A & 0.0\\% (0/6) \\\\\n\\hline Ventricular septal perforation (periprocedural) & \\begin{tabular}{l}\n0.0\\% \\\\\n(0/10)\n\\end{tabular} & N/A & \\begin{tabular}{l}\n0.0\\% \\\\\n(0/10)\n\\end{tabular} & 0.0\\% (0/7) & N/A & 0.0\\% (0/6) \\\\\n\\hline Mitral apparatus damage (periprocedural) & \\begin{tabular}{l}\n0.0\\% \\\\\n(0/10)\n\\end{tabular} & N/A & \\begin{tabular}{l}\n0.0\\% \\\\\n(0/10)\n\\end{tabular} & 0.0\\% (0/7) & N/A & 0.0\\% (0/6) \\\\\n\\hline Cardiac tamponade (periprocedural) & \\begin{tabular}{l}\n0.0\\% \\\\\n(0/10)\n\\end{tabular} & N/A & \\begin{tabular}{l}\n10.0\\% \\\\\n(1/10)\n\\end{tabular} & 0.0\\% (0/7) & N/A & 0.0\\% (0/6) \\\\\n\\hline Prosthetic aortic valve malpositioning & \\begin{tabular}{l}\n0.0\\% \\\\\n(0/10)\n\\end{tabular} & \\begin{tabular}{l}\n0.0\\% \\\\\n(0/10)\n\\end{tabular} & \\begin{tabular}{l}\n0.0\\% \\\\\n(0/10)\n\\end{tabular} & 0.0\\% (0/7) & \\begin{tabular}{l}\n0.0\\% \\\\\n(0/5)\n\\end{tabular} & \\begin{tabular}{l}\n0.0\\% \\\\\n(0/6)\n\\end{tabular} \\\\\n\\hline Prosthetic aortic valve thrombosis & \\begin{tabular}{l}\n0.0\\% \\\\\n(0/10)\n\\end{tabular} & \\begin{tabular}{l}\n0.0\\% \\\\\n(0/10)\n\\end{tabular} & \\begin{tabular}{l}\n10.0\\% \\\\\n(1/10)\n\\end{tabular} & 0.0\\% (0/7) & \\begin{tabular}{l}\n0.0\\% \\\\\n(0/5)\n\\end{tabular} & \\begin{tabular}{l}\n0.0\\% \\\\\n(0/6)\n\\end{tabular} \\\\\n\\hline Prosthetic aortic valve endocarditis & \\begin{tabular}{l}\n0.0\\% \\\\\n(0/10)\n\\end{tabular} & \\begin{tabular}{l}\n0.0\\% \\\\\n(0/10)\n\\end{tabular} & \\begin{tabular}{l}\n0.0\\% \\\\\n(0/10)\n\\end{tabular} & 0.0\\% (0/7) & 0.0\\% (0/5) & 16.7\\% (1/6) \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Table 4.1-6: Clinical Outcomes in REPRISE NG DS Cohorts A and B}\n\\begin{tabular}{|l|l|l|l|l|l|l|}\n\\hline \\multirow{2}{*}{VARC Event} & \\multicolumn{3}{|c|}{Cohort A ( \\(N = 1 0\\) )} & \\multicolumn{3}{|c|}{Cohort B ( \\(N = 7\\) )} \\\\\n\\hline & Discharge & 30 Days & 1 Year & Discharge & 30 Days & 1 Year \\\\\n\\hline New PPM & \\begin{tabular}{l}\n0.0\\% \\\\\n(0/10)\n\\end{tabular} & \\begin{tabular}{l}\n30.0\\% \\\\\n(3/10)\n\\end{tabular} & \\begin{tabular}{l}\n40.0\\% \\\\\n(4/10)\n\\end{tabular} & 0.0\\% (0/7) & \\begin{tabular}{l}\n0.0\\% \\\\\n(0/5)\n\\end{tabular} & \\begin{tabular}{l}\n0.0\\% \\\\\n(0/6)\n\\end{tabular} \\\\\n\\hline Life-threatening/disabling bleeding & \\begin{tabular}{l}\n20.0\\% \\\\\n(2/10)\n\\end{tabular} & \\begin{tabular}{l}\n20.0\\% \\\\\n(2/10)\n\\end{tabular} & \\begin{tabular}{l}\n20.0\\% \\\\\n(2/10)\n\\end{tabular} & 0.0\\% (0/7) & \\begin{tabular}{l}\n0.0\\% \\\\\n(0/5)\n\\end{tabular} & \\begin{tabular}{l}\n0.0\\% \\\\\n(0/6)\n\\end{tabular} \\\\\n\\hline Myocardial infarction & \\begin{tabular}{l}\n0.0\\% \\\\\n(0/10)\n\\end{tabular} & \\begin{tabular}{l}\n0.0\\% \\\\\n(0/10)\n\\end{tabular} & \\begin{tabular}{l}\n0.0\\% \\\\\n(0/10)\n\\end{tabular} & 0.0\\% (0/7) & \\begin{tabular}{l}\n0.0\\% \\\\\n(0/5)\n\\end{tabular} & 0.0\\% (0/6) \\\\\n\\hline Acute kidney injury - Stage 2/3 & \\begin{tabular}{l}\n10.0\\% \\\\\n(1/10)\n\\end{tabular} & \\begin{tabular}{l}\n10.0\\% \\\\\n(1/10)\n\\end{tabular} & \\begin{tabular}{l}\n10.0\\% \\\\\n(1/10)\n\\end{tabular} & 0.0\\% (0/7) & \\begin{tabular}{l}\n0.0\\% \\\\\n(0/5)\n\\end{tabular} & 0.0\\% (0/6) \\\\\n\\hline Repeat procedure for valve-related dysfunction (surgical/interventional) & \\begin{tabular}{l}\n0.0\\% \\\\\n(0/10)\n\\end{tabular} & \\begin{tabular}{l}\n0.0\\% \\\\\n(0/10)\n\\end{tabular} & \\begin{tabular}{l}\n0.0\\% \\\\\n(0/10)\n\\end{tabular} & 0.0\\% (0/7) & \\begin{tabular}{l}\n0.0\\% \\\\\n(0/5)\n\\end{tabular} & 0.0\\% (0/6) \\\\\n\\hline Hospitalization for valve-related symptoms or worsening CHF & \\begin{tabular}{l}\n0.0\\% \\\\\n(0/10)\n\\end{tabular} & \\begin{tabular}{l}\n0.0\\% \\\\\n(0/10)\n\\end{tabular} & \\begin{tabular}{l}\n0.0\\% \\\\\n(0/10)\n\\end{tabular} & 0.0\\% (0/7) & \\begin{tabular}{l}\n0.0\\% \\\\\n(0/5)\n\\end{tabular} & 16.7\\% (1/6) \\\\\n\\hline New onset atrial fibrillation/flutter & \\begin{tabular}{l}\n0.0\\% \\\\\n(0/10)\n\\end{tabular} & \\begin{tabular}{l}\n0.0\\% \\\\\n(0/10)\n\\end{tabular} & \\begin{tabular}{l}\n0.0\\% \\\\\n(0/10)\n\\end{tabular} & 0.0\\% (0/7) & \\begin{tabular}{l}\n0.0\\% \\\\\n(0/5)\n\\end{tabular} & 0.0\\% (0/6) \\\\\n\\hline Coronary obstruction (periprocedural) & \\begin{tabular}{l}\n0.0\\% \\\\\n(0/10)\n\\end{tabular} & N/A & \\begin{tabular}{l}\n0.0\\% \\\\\n(0/10)\n\\end{tabular} & 0.0\\% (0/7) & N/A & 0.0\\% (0/6) \\\\\n\\hline Ventricular septal perforation (periprocedural) & \\begin{tabular}{l}\n0.0\\% \\\\\n(0/10)\n\\end{tabular} & N/A & \\begin{tabular}{l}\n0.0\\% \\\\\n(0/10)\n\\end{tabular} & 0.0\\% (0/7) & N/A & 0.0\\% (0/6) \\\\\n\\hline Mitral apparatus damage (periprocedural) & \\begin{tabular}{l}\n0.0\\% \\\\\n(0/10)\n\\end{tabular} & N/A & \\begin{tabular}{l}\n0.0\\% \\\\\n(0/10)\n\\end{tabular} & 0.0\\% (0/7) & N/A & 0.0\\% (0/6) \\\\\n\\hline Cardiac tamponade (periprocedural) & \\begin{tabular}{l}\n0.0\\% \\\\\n(0/10)\n\\end{tabular} & N/A & \\begin{tabular}{l}\n10.0\\% \\\\\n(1/10)\n\\end{tabular} & 0.0\\% (0/7) & N/A & 0.0\\% (0/6) \\\\\n\\hline Prosthetic aortic valve malpositioning & \\begin{tabular}{l}\n0.0\\% \\\\\n(0/10)\n\\end{tabular} & \\begin{tabular}{l}\n0.0\\% \\\\\n(0/10)\n\\end{tabular} & \\begin{tabular}{l}\n0.0\\% \\\\\n(0/10)\n\\end{tabular} & 0.0\\% (0/7) & \\begin{tabular}{l}\n0.0\\% \\\\\n(0/5)\n\\end{tabular} & \\begin{tabular}{l}\n0.0\\% \\\\\n(0/6)\n\\end{tabular} \\\\\n\\hline Prosthetic aortic valve thrombosis & \\begin{tabular}{l}\n0.0\\% \\\\\n(0/10)\n\\end{tabular} & \\begin{tabular}{l}\n0.0\\% \\\\\n(0/10)\n\\end{tabular} & \\begin{tabular}{l}\n10.0\\% \\\\\n(1/10)\n\\end{tabular} & 0.0\\% (0/7) & \\begin{tabular}{l}\n0.0\\% \\\\\n(0/5)\n\\end{tabular} & \\begin{tabular}{l}\n0.0\\% \\\\\n(0/6)\n\\end{tabular} \\\\\n\\hline Prosthetic aortic valve endocarditis & \\begin{tabular}{l}\n0.0\\% \\\\\n(0/10)\n\\end{tabular} & \\begin{tabular}{l}\n0.0\\% \\\\\n(0/10)\n\\end{tabular} & \\begin{tabular}{l}\n0.0\\% 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The commissures of the leaflets are attached to the valve frame through portions of","text_display":" leaflets. The commissures of the leaflets are attached to the valve frame through portions of","confidence":1,"confidence_rate":1},{"cnt":[[309,2144],[1871,2144],[1871,2189],[309,2189]],"region":{"top_left_x":309,"top_left_y":2144,"width":1563,"height":46},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dd2f2877b42b4f94b65cd5149994c69d","type":"text","conversion_output":true,"text":"the locking components. The valve frame is made of a single nitinol wire strand woven into a","text_display":" the locking components. 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The braided","confidence":1,"confidence_rate":1},{"cnt":[[309,2288],[1871,2288],[1871,2331],[309,2331]],"region":{"top_left_x":309,"top_left_y":2288,"width":1563,"height":44},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"93f114ae2c5a4cd6b352068d74a90c87","type":"text","conversion_output":true,"text":"structure is designed to foreshorten and expand radially when delivered, and is then locked in","text_display":" structure is designed to foreshorten and expand radially when delivered, and is then locked in","confidence":1,"confidence_rate":1},{"cnt":[[309,2333],[1800,2333],[1800,2380],[309,2380]],"region":{"top_left_x":309,"top_left_y":2333,"width":1492,"height":48},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6865ef3e1d164faa96bf422ed0ef43ab","type":"text","conversion_output":true,"text":"this position using a post and buckle locking mechanism. 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The valve begins to function early in the deployment process, facilitating","text_display":" deployment. 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In the deployed state, the frame","text_display":" 27 mm (depending on valve size) when the valve is locked. In the deployed state, the frame","confidence":1,"confidence_rate":1},{"cnt":[[309,793],[1867,793],[1867,840],[309,840]],"region":{"top_left_x":309,"top_left_y":792,"width":1558,"height":49},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5d8df73f9a1c4fba9e3223df4465d2b0","type":"text","conversion_output":true,"text":"height of the 21 mm valve is approximately 15 mm ; the frame height of the three larger valve","text_display":" height of the 21 mm valve is approximately 15 mm ; the frame height of the three larger valve","confidence":0.9990234375,"confidence_rate":0.9999909533775151},{"cnt":[[309,842],[1826,842],[1826,889],[309,889]],"region":{"top_left_x":309,"top_left_y":842,"width":1518,"height":48},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e9a67f044d4747e68c2fcd7a86b15e91","type":"text","conversion_output":true,"text":"sizes is approximately 19 mm . Similarly, the LOTUS Edge Valve is designed to produce a","text_display":" sizes is approximately 19 mm . 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The valve component","confidence":0.99951171875,"confidence_rate":0.9999951643631956},{"cnt":[[309,984],[1815,984],[1815,1033],[309,1033]],"region":{"top_left_x":309,"top_left_y":983,"width":1507,"height":51},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dfa6104182b64711b11e3cb3ae86ef09","type":"text","conversion_output":true,"text":"of the 29 mm LOTUS Edge device is scaled from the \\(21 mm, 23 mm, 25 mm\\), and 27 mm","text_display":" of the 29 mm LOTUS Edge device is scaled from the \\(21 mm, 23 mm, 25 mm\\), and 27 mm","confidence":0.99951171875,"confidence_rate":0.9999950666738041},{"cnt":[[309,1031],[1841,1031],[1841,1081],[309,1081]],"region":{"top_left_x":309,"top_left_y":1031,"width":1533,"height":50},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b5cf4cdd14ca4e28b2ad083b46706abf","type":"text","conversion_output":true,"text":"valve sizes. Additionally, the LOTUS Edge 29 mm valve has a pad sewn between the braid","text_display":" valve sizes. 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Lotus and LOTUS Edge Delivery System}","confidence":1,"confidence_rate":1},{"cnt":[[309,1919],[1858,1919],[1858,1966],[309,1966]],"region":{"top_left_x":309,"top_left_y":1918,"width":1550,"height":48},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"163de14b16e047f78f46f607bdb11b54","type":"text","conversion_output":true,"text":"The Lotus Valve and LOTUS Edge Valve have a Delivery System comprised of the catheter","text_display":"\n\nThe Lotus Valve and LOTUS Edge Valve have a Delivery System comprised of the catheter","confidence":1,"confidence_rate":1},{"cnt":[[309,1968],[735,1968],[735,2009],[309,2009]],"region":{"top_left_x":309,"top_left_y":1967,"width":426,"height":42},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a413f86364c64b71bf8201d4eed15987","type":"text","conversion_output":true,"text":"and the Lotus Controller.","text_display":" and the Lotus Controller.","confidence":1,"confidence_rate":1},{"cnt":[[309,2039],[1833,2039],[1833,2086],[309,2086]],"region":{"top_left_x":309,"top_left_y":2038,"width":1524,"height":49},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2e50b25acab648d69bbb2d0fda62c346","type":"text","conversion_output":true,"text":"- The catheter is a sheath in which mandrels allowing the shortening, locking, unlocking,","text_display":"\n- The catheter is a sheath in which mandrels allowing the shortening, locking, unlocking,","confidence":1,"confidence_rate":1},{"cnt":[[372,2088],[1858,2088],[1858,2133],[372,2133]],"region":{"top_left_x":371,"top_left_y":2088,"width":1488,"height":46},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d614b42f5e714a2f816b852b7ccb0870","type":"text","conversion_output":true,"text":"and elongation of the valve, as well as its releasing, connect from the Lotus Controller to","text_display":" and elongation of the valve, as well as its releasing, connect from the Lotus Controller to","confidence":1,"confidence_rate":1},{"cnt":[[372,2136],[1863,2136],[1863,2185],[372,2185]],"region":{"top_left_x":371,"top_left_y":2135,"width":1492,"height":50},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fbe0240653924c1888b89d4795f6907d","type":"text","conversion_output":true,"text":"the valve. The catheter has a hydrophilic coating to facilitate the insertion. The tip of the","text_display":" the valve. The catheter has a hydrophilic coating to facilitate the insertion. The tip of the","confidence":1,"confidence_rate":1},{"cnt":[[372,2183],[1629,2183],[1629,2232],[372,2232]],"region":{"top_left_x":371,"top_left_y":2182,"width":1258,"height":51},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c720e34b526d4dbab47ebd58a80e8145","type":"text","conversion_output":true,"text":"catheter seats on the shoulder of a nosecone to provide a smooth transition.","text_display":" catheter seats on the shoulder of a nosecone to provide a smooth transition.","confidence":0.99951171875,"confidence_rate":0.9999939703823991},{"cnt":[[309,2256],[1158,2256],[1158,2305],[309,2305]],"region":{"top_left_x":309,"top_left_y":2255,"width":850,"height":51},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6e145c19df534401a598baef455daf99","type":"text","conversion_output":true,"text":"- The Lotus Controller is shown in Figure 5.1-3.","text_display":"\n- The Lotus Controller is shown in Figure 5.1-3.","confidence":0.9970703125,"confidence_rate":0.9999446432787533},{"cnt":[[374,2312],[1833,2312],[1833,2361],[374,2361]],"region":{"top_left_x":373,"top_left_y":2311,"width":1460,"height":51},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"aa27a9b412634c728bb682d530717e59","type":"text","conversion_output":true,"text":"- The Lotus Controller has 3 ports; 2 of the ports are for flushing purposes and one is","text_display":"\n- The Lotus Controller has 3 ports; 2 of the ports are for flushing purposes and one is","confidence":0.9985356330871582,"confidence_rate":0.9999850466409257},{"cnt":[[434,2359],[767,2359],[767,2408],[434,2408]],"region":{"top_left_x":433,"top_left_y":2358,"width":334,"height":51},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"028a2f6f93b941bd95e6fbdcb3921198","type":"text","conversion_output":true,"text":"the Guidewire Port.","text_display":" the Guidewire Port.","confidence":1,"confidence_rate":1},{"cnt":[[103,2651],[312,2651],[312,2690],[103,2690]],"region":{"top_left_x":103,"top_left_y":2651,"width":209,"height":39},"line":39,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"484f32c368ed47f18bd9081b4d5e364b","type":"page_info","conversion_output":false,"text":"Released","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[829,2655],[1291,2655],[1291,2690],[829,2690]],"region":{"top_left_x":829,"top_left_y":2655,"width":463,"height":35},"line":40,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"06188c3ec67149f0aced014d317f8217","type":"page_info","conversion_output":false,"text":"REPRISE III Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1656,2655],[1983,2655],[1983,2688],[1656,2688]],"region":{"top_left_x":1656,"top_left_y":2655,"width":328,"height":33},"line":41,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e7e673f9cb764c24be46ebe16d9efd79","type":"page_info","conversion_output":false,"text":"90899936 AK. 4","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[488,2690],[2000,2690],[2000,2731],[488,2731]],"region":{"top_left_x":487,"top_left_y":2689,"width":1514,"height":42},"line":42,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"56d0c24409164d25a237a0f137ff7d0d","type":"page_info","conversion_output":false,"text":"Boston Scientific Confidential. 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It operates both the sheathing/unsheathing function as well","text_display":" used to deploy the valve. 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The large Lotus Introducer (LIS-L) is also suitable for use with the LOTUS Edge","text_display":" \\(\\geq 6.5 mm\\). 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Enrolled subjects","confidence":0.99951171875,"confidence_rate":0.9999951643631956},{"cnt":[[309,559],[1867,559],[1867,608],[309,608]],"region":{"top_left_x":309,"top_left_y":558,"width":1558,"height":51},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c50850904e3f4b84ada6720e74659519","type":"text","conversion_output":true,"text":"who do not have a study device implanted will be assessed through 1 year post procedure for","text_display":" who do not have a study device implanted will be assessed through 1 year post procedure for","confidence":0.99951171875,"confidence_rate":0.9999950666738041},{"cnt":[[309,608],[679,608],[679,655],[309,655]],"region":{"top_left_x":309,"top_left_y":608,"width":370,"height":48},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dc547a6c67b544f7a1583d09ed861f3d","type":"text","conversion_output":true,"text":"safety/adverse events.","text_display":" safety/adverse events.","confidence":1,"confidence_rate":1},{"cnt":[[309,677],[1747,677],[1747,724],[309,724]],"region":{"top_left_x":309,"top_left_y":676,"width":1438,"height":49},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d37c62fa5fd14a63b09bb8ee3716f595","type":"text","conversion_output":true,"text":"The REPRISE III study will be conducted in accordance with the relevant parts of the","text_display":"\n\nThe REPRISE III study will be conducted in accordance with the relevant parts of the","confidence":1,"confidence_rate":1},{"cnt":[[309,724],[1807,724],[1807,769],[309,769]],"region":{"top_left_x":309,"top_left_y":724,"width":1498,"height":46},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"04cddee807a14020b7f7112756195fb7","type":"text","conversion_output":true,"text":"International Conference on Harmonisation (ICH) Guidelines for Good Clinical Practices","text_display":" International Conference on Harmonisation (ICH) Guidelines for Good Clinical Practices","confidence":1,"confidence_rate":1},{"cnt":[[309,773],[1768,773],[1768,819],[309,819]],"region":{"top_left_x":309,"top_left_y":773,"width":1460,"height":46},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"29a50f6fcd2b4bedb813721b09ac34c9","type":"text","conversion_output":true,"text":"(GCP) or the International Standard ISO 14155: 2011; ethical principles that have their","text_display":" (GCP) or the International Standard ISO 14155: 2011; ethical principles that have their","confidence":0.9990234375,"confidence_rate":0.9999893800602199},{"cnt":[[309,821],[1833,821],[1833,866],[309,866]],"region":{"top_left_x":309,"top_left_y":820,"width":1524,"height":46},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cefdc3c2ed3c4ef3a20a669a4293c7ac","type":"text","conversion_output":true,"text":"origins in the Declaration of Helsinki; and pertinent individual country/state/local laws and","text_display":" origins in the Declaration of Helsinki; and pertinent individual country/state/local laws and","confidence":1,"confidence_rate":1},{"cnt":[[309,868],[1747,868],[1747,915],[309,915]],"region":{"top_left_x":309,"top_left_y":867,"width":1438,"height":49},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"60378e176aed428d93b25c7cebc50f35","type":"text","conversion_output":true,"text":"regulations. See Section 11 below for additional information on study design and data","text_display":" regulations. See Section 11 below for additional information on study design and data","confidence":1,"confidence_rate":1},{"cnt":[[309,915],[488,915],[488,956],[309,956]],"region":{"top_left_x":309,"top_left_y":915,"width":179,"height":42},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4bc175738ea54e06ad6c1ca1b119b4b3","type":"text","conversion_output":true,"text":"collection.","text_display":" collection.","confidence":1,"confidence_rate":1},{"cnt":[[309,984],[1876,984],[1876,1033],[309,1033]],"region":{"top_left_x":309,"top_left_y":983,"width":1567,"height":51},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bcd2333abe42446a8b4e0a436658f145","type":"text","conversion_output":true,"text":"The REPRISE III study will be registered at ClinicalTrials.gov prior to enrollment of the first","text_display":"\n\nThe REPRISE III study will be registered at ClinicalTrials.gov prior to enrollment of the first","confidence":0.99560546875,"confidence_rate":0.999955958813992},{"cnt":[[309,1033],[443,1033],[443,1081],[309,1081]],"region":{"top_left_x":309,"top_left_y":1033,"width":134,"height":48},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7586ba610d27462aa86d812c73a09190","type":"text","conversion_output":true,"text":"subject.","text_display":" subject.","confidence":1,"confidence_rate":1},{"cnt":[[305,1121],[838,1121],[838,1175],[305,1175]],"region":{"top_left_x":305,"top_left_y":1121,"width":533,"height":55},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6581cdda835c43ae9689528299c036cc","type":"section_header","conversion_output":false,"children_ids":["bf0d174b2eb942bbb53243327c8b0422"],"text":"","text_display":""},{"cnt":[[309,1124],[836,1124],[836,1171],[309,1171]],"region":{"top_left_x":309,"top_left_y":1123,"width":527,"height":48},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bf0d174b2eb942bbb53243327c8b0422","type":"text","conversion_output":true,"parent_id":"6581cdda835c43ae9689528299c036cc","text":"8.2 Treatment Assignment","text_display":"\n\n\\subsection*{8.2 Treatment Assignment}","confidence":0.52880859375,"confidence_rate":0.9782696252309915},{"cnt":[[309,1212],[1837,1212],[1837,1259],[309,1259]],"region":{"top_left_x":309,"top_left_y":1211,"width":1528,"height":48},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e3215db1343449fe9ac79f627bba14d8","type":"text","conversion_output":true,"text":"Screening materials from eligible subjects who are identified by the investigators as having","text_display":"\n\nScreening materials from eligible subjects who are identified by the investigators as having","confidence":1,"confidence_rate":1},{"cnt":[[309,1259],[1871,1259],[1871,1308],[309,1308]],"region":{"top_left_x":309,"top_left_y":1258,"width":1563,"height":51},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a6a415fa528f4c84b9f5c32e146bb17d","type":"text","conversion_output":true,"text":"met the inclusion and exclusion criteria (see below Table 9.2-1 and Table 9.3-1, respectively)","text_display":" met the inclusion and exclusion criteria (see below Table 9.2-1 and Table 9.3-1, respectively)","confidence":1,"confidence_rate":1},{"cnt":[[309,1308],[1828,1308],[1828,1354],[309,1354]],"region":{"top_left_x":309,"top_left_y":1308,"width":1520,"height":46},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"90dc836edcdf4d96b3f7ca860e6cece7","type":"text","conversion_output":true,"text":"and who provide written informed consent, will be reviewed by a Case Review Committee","text_display":" and who provide written informed consent, will be reviewed by a Case Review Committee","confidence":0.99462890625,"confidence_rate":0.9999401621244394},{"cnt":[[309,1354],[1714,1354],[1714,1403],[309,1403]],"region":{"top_left_x":309,"top_left_y":1353,"width":1406,"height":50},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"11c9397cd10147d49d890dc86a15f533","type":"text","conversion_output":true,"text":"(CRC; see Section 22.2) to assess and confirm suitability of subjects for enrollment.","text_display":" (CRC; see Section 22.2) to assess and confirm suitability of subjects for enrollment.","confidence":1,"confidence_rate":1},{"cnt":[[309,1422],[1867,1422],[1867,1472],[309,1472]],"region":{"top_left_x":309,"top_left_y":1422,"width":1558,"height":50},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4567aed92ade4c248540fe80fa2f9b2c","type":"text","conversion_output":true,"text":"For the randomized cohort, eligible subjects will be randomized in a \\(2: 1\\) allocation to receive","text_display":"\n\nFor the randomized cohort, eligible subjects will be randomized in a \\(2: 1\\) allocation to receive","confidence":0.9975595474243164,"confidence_rate":0.999976045038553},{"cnt":[[309,1465],[1863,1465],[1863,1519],[309,1519]],"region":{"top_left_x":309,"top_left_y":1465,"width":1554,"height":54},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"49ae3141c0d54116a382d303334dc332","type":"text","conversion_output":true,"text":"either the Lotus Valve System (test) or a commercially available self-expanding CoreValve \\({ }^{\\circledR}\\)","text_display":" either the Lotus Valve System (test) or a commercially available self-expanding CoreValve \\({ }^{\\circledR}\\)","confidence":0.990234375,"confidence_rate":0.99990379265324},{"cnt":[[309,1519],[1871,1519],[1871,1566],[309,1566]],"region":{"top_left_x":309,"top_left_y":1518,"width":1563,"height":49},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bc8d5df5895b467e99ac12fed4eb28b4","type":"text","conversion_output":true,"text":"Transcatheter Aortic Valve Replacement System (control). The randomization schedules will","text_display":" Transcatheter Aortic Valve Replacement System (control). The randomization schedules will","confidence":1,"confidence_rate":1},{"cnt":[[309,1568],[1815,1568],[1815,1618],[309,1618]],"region":{"top_left_x":309,"top_left_y":1568,"width":1507,"height":50},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f6dfc0f917224f58a9c1e84668a02d81","type":"text","conversion_output":true,"text":"be computer-generated, using a pseudo-random number generator. Randomization will be","text_display":" be computer-generated, using a pseudo-random number generator. Randomization will be","confidence":1,"confidence_rate":1},{"cnt":[[309,1616],[1837,1616],[1837,1663],[309,1663]],"region":{"top_left_x":309,"top_left_y":1615,"width":1528,"height":48},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d3ff81d18a424d2bb36ec5ae1c52f502","type":"text","conversion_output":true,"text":"stratified by center and by high or extreme risk status (see Section 26.2 for definitions). All","text_display":" stratified by center and by high or extreme risk status (see Section 26.2 for definitions). All","confidence":1,"confidence_rate":1},{"cnt":[[309,1663],[1858,1663],[1858,1712],[309,1712]],"region":{"top_left_x":309,"top_left_y":1662,"width":1550,"height":51},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ec8d23391a244cd881bfaaf41d931f2c","type":"text","conversion_output":true,"text":"randomized subjects will have unique identification numbers. Random permuted blocks will","text_display":" randomized subjects will have unique identification numbers. Random permuted blocks will","confidence":1,"confidence_rate":1},{"cnt":[[309,1712],[1783,1712],[1783,1760],[309,1760]],"region":{"top_left_x":309,"top_left_y":1712,"width":1475,"height":48},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9a5b1f3c6cd5457eb07411abbad3be43","type":"text","conversion_output":true,"text":"be employed to ensure approximate balance of treatment allocation within each stratum.","text_display":" be employed to ensure approximate balance of treatment allocation within each stratum.","confidence":1,"confidence_rate":1},{"cnt":[[309,1760],[1833,1760],[1833,1807],[309,1807]],"region":{"top_left_x":309,"top_left_y":1759,"width":1524,"height":48},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8368ffc3d46340aabc5f27346bebea62","type":"text","conversion_output":true,"text":"Instructions on randomization are provided in the Manual of Operations. Subject should be","text_display":" Instructions on randomization are provided in the Manual of Operations. Subject should be","confidence":1,"confidence_rate":1},{"cnt":[[309,1807],[1824,1807],[1824,1854],[309,1854]],"region":{"top_left_x":309,"top_left_y":1806,"width":1516,"height":49},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cf1886c2fdc944d38047ed16cf78022f","type":"text","conversion_output":true,"text":"randomized within 7 calendar days of CRC approval. Subjects should be treated within 14","text_display":" randomized within 7 calendar days of CRC approval. Subjects should be treated within 14","confidence":1,"confidence_rate":1},{"cnt":[[309,1856],[1768,1856],[1768,1901],[309,1901]],"region":{"top_left_x":309,"top_left_y":1856,"width":1460,"height":46},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dd579e8f62bc48d2890e7fe0902deece","type":"text","conversion_output":true,"text":"calendar days of randomization and no later than 30 calendar days after randomization.","text_display":" calendar days of randomization and no later than 30 calendar days after randomization.","confidence":1,"confidence_rate":1},{"cnt":[[305,1925],[1858,1925],[1858,1970],[305,1970]],"region":{"top_left_x":305,"top_left_y":1925,"width":1554,"height":46},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4bd53d461b1f4dd19c9b1878fb7b08fd","type":"text","conversion_output":true,"text":"Note: There will be a non-randomized roll-in phase with only the test device for centers that","text_display":"\n\nNote: There will be a non-randomized roll-in phase with only the test device for centers that","confidence":1,"confidence_rate":1},{"cnt":[[309,1972],[1766,1972],[1766,2020],[309,2020]],"region":{"top_left_x":309,"top_left_y":1972,"width":1458,"height":48},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2c1f8a6dcf6d4457bf1125aeee16fff5","type":"text","conversion_output":true,"text":"do not have previous experience implanting the Lotus Valve; each of these centers will","text_display":" do not have previous experience implanting the Lotus Valve; each of these centers will","confidence":0.99951171875,"confidence_rate":0.9999946329759618},{"cnt":[[309,2020],[1824,2020],[1824,2069],[309,2069]],"region":{"top_left_x":309,"top_left_y":2019,"width":1516,"height":50},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3ad8a6ba4b51436d89e5e742fd5f98ce","type":"text","conversion_output":true,"text":"perform at least 2 roll-in cases before commencing randomization. All roll-in subjects will","text_display":" perform at least 2 roll-in cases before commencing randomization. All roll-in subjects will","confidence":1,"confidence_rate":1},{"cnt":[[309,2069],[1762,2069],[1762,2116],[309,2116]],"region":{"top_left_x":309,"top_left_y":2068,"width":1453,"height":49},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"933605afa1d54996b0eb1e1d5339afe9","type":"text","conversion_output":true,"text":"have unique identification numbers. Subjects receiving the 21 mm Lotus Valve will be","text_display":" have unique identification numbers. Subjects receiving the 21 mm Lotus Valve will be","confidence":1,"confidence_rate":1},{"cnt":[[309,2118],[1863,2118],[1863,2163],[309,2163]],"region":{"top_left_x":309,"top_left_y":2118,"width":1554,"height":46},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"402972135e33488cbc401749beff3ff4","type":"text","conversion_output":true,"text":"enrolled in a non-randomized, nested registry cohort to assess safety and effectiveness. After","text_display":" enrolled in a non-randomized, nested registry cohort to assess safety and effectiveness. 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Subject Selection","text_display":"\n\n\\section*{9. Subject Selection}","confidence":0.998046875,"confidence_rate":0.9999218016642171},{"cnt":[[305,460],[999,460],[999,518],[305,518]],"region":{"top_left_x":305,"top_left_y":459,"width":695,"height":59},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cc827acd8b4f45bf9b3cc3dd91aaded4","type":"section_header","conversion_output":false,"children_ids":["e6d727cebda647ea9033b498200d8449"],"text":"","text_display":""},{"cnt":[[309,464],[995,464],[995,513],[309,513]],"region":{"top_left_x":309,"top_left_y":464,"width":686,"height":50},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e6d727cebda647ea9033b498200d8449","type":"text","conversion_output":true,"parent_id":"cc827acd8b4f45bf9b3cc3dd91aaded4","text":"9.1. Study Population and Eligibility","text_display":"\n\n\\subsection*{9.1. Study Population and Eligibility}","confidence":0.99658203125,"confidence_rate":0.9999184837190718},{"cnt":[[309,554],[1807,554],[1807,604],[309,604]],"region":{"top_left_x":309,"top_left_y":554,"width":1498,"height":50},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"09f516bc02d44bcf89309388db211d7d","type":"text","conversion_output":true,"text":"The study will include subjects presenting with symptomatic calcific, severe native aortic","text_display":"\n\nThe study will include subjects presenting with symptomatic calcific, severe native aortic","confidence":1,"confidence_rate":1},{"cnt":[[309,604],[1764,604],[1764,651],[309,651]],"region":{"top_left_x":309,"top_left_y":603,"width":1455,"height":48},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e17ad3972aee40139ffbd6fc57a8c679","type":"text","conversion_output":true,"text":"stenosis who are considered at extreme or high risk for surgical valve replacement (see","text_display":" stenosis who are considered at extreme or high risk for surgical valve replacement (see","confidence":1,"confidence_rate":1},{"cnt":[[309,649],[1858,649],[1858,698],[309,698]],"region":{"top_left_x":309,"top_left_y":648,"width":1550,"height":51},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9ec7cd83ff624d49875cd8aee36cc677","type":"text","conversion_output":true,"text":"definitions of operative risk in Section 26.2). Traditionally underrepresented populations are","text_display":" definitions of operative risk in Section 26.2). Traditionally underrepresented populations are","confidence":1,"confidence_rate":1},{"cnt":[[309,696],[1824,696],[1824,746],[309,746]],"region":{"top_left_x":309,"top_left_y":696,"width":1516,"height":50},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"789010def7164514a2c7ed147b7652a0","type":"text","conversion_output":true,"text":"expected to be included in the subject population. Because aortic stenosis most commonly","text_display":" expected to be included in the subject population. Because aortic stenosis most commonly","confidence":1,"confidence_rate":1},{"cnt":[[309,746],[1867,743],[1867,795],[309,797]],"region":{"top_left_x":309,"top_left_y":743,"width":1559,"height":55},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2827a49c64414cd2a21c268286052a52","type":"text","conversion_output":true,"text":"occurs in the very elderly, women represent the majority of subjects enrolled in many TAVR","text_display":" occurs in the very elderly, women represent the majority of subjects enrolled in many TAVR","confidence":1,"confidence_rate":1},{"cnt":[[309,793],[1833,793],[1833,844],[309,844]],"region":{"top_left_x":309,"top_left_y":792,"width":1524,"height":53},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0c55868c692a4b4caf10d87fe85bea7d","type":"text","conversion_output":true,"text":"trials. All efforts will be made to minimize attrition in REPRISE III. Since the very elderly","text_display":" trials. All efforts will be made to minimize attrition in REPRISE III. Since the very elderly","confidence":1,"confidence_rate":1},{"cnt":[[305,838],[1790,838],[1790,892],[305,892]],"region":{"top_left_x":305,"top_left_y":837,"width":1485,"height":55},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"309b4e297f19475fa2bb47cd25e0b46e","type":"text","conversion_output":true,"text":"will represent the majority of subjects enrolled in the trial, these efforts are by definition","text_display":" will represent the majority of subjects enrolled in the trial, these efforts are by definition","confidence":1,"confidence_rate":1},{"cnt":[[305,889],[1154,889],[1154,939],[305,939]],"region":{"top_left_x":305,"top_left_y":889,"width":849,"height":50},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2119b6c858be45039bccfe1c5c2d897b","type":"text","conversion_output":true,"text":"targeted to traditionally under-represented groups.","text_display":" targeted to traditionally under-represented groups.","confidence":1,"confidence_rate":1},{"cnt":[[307,958],[1807,958],[1807,1008],[307,1008]],"region":{"top_left_x":307,"top_left_y":958,"width":1500,"height":50},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b0e3d0aac5d04717bb559cb542d9503f","type":"text","conversion_output":true,"text":"Prior to being eligible for the REPRISE III study, a subject must meet all of the inclusion","text_display":"\n\nPrior to being eligible for the REPRISE III study, a subject must meet all of the inclusion","confidence":1,"confidence_rate":1},{"cnt":[[305,1005],[1775,1005],[1775,1055],[305,1055]],"region":{"top_left_x":305,"top_left_y":1005,"width":1470,"height":50},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6c8018a9326e498e96db7d2130fa18c9","type":"text","conversion_output":true,"text":"criteria (Section 9.2) and none of the exclusion criteria (Section 9.3). The inclusion and","text_display":" criteria (Section 9.2) and none of the exclusion criteria (Section 9.3). The inclusion and","confidence":1,"confidence_rate":1},{"cnt":[[305,1053],[1815,1053],[1815,1102],[305,1102]],"region":{"top_left_x":305,"top_left_y":1052,"width":1511,"height":51},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6c5250c3d449415da78fb8f493ea1fa2","type":"text","conversion_output":true,"text":"exclusion criteria are not expected to have a negative effect on recruitment or retention of","text_display":" exclusion criteria are not expected to have a negative effect on recruitment or retention of","confidence":1,"confidence_rate":1},{"cnt":[[305,1100],[1046,1100],[1046,1154],[305,1154]],"region":{"top_left_x":305,"top_left_y":1100,"width":742,"height":54},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7068a307f0804498bc294fe3f547653b","type":"text","conversion_output":true,"text":"traditionally under-represented populations.","text_display":" traditionally under-represented populations.","confidence":1,"confidence_rate":1},{"cnt":[[303,1190],[758,1190],[758,1240],[303,1240]],"region":{"top_left_x":302,"top_left_y":1190,"width":457,"height":50},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c57b1ce39ba24356bd276691af49af02","type":"section_header","conversion_output":false,"children_ids":["d4bdda27374740b6b0b4b2674372a174"],"text":"","text_display":""},{"cnt":[[305,1195],[752,1195],[752,1235],[305,1235]],"region":{"top_left_x":305,"top_left_y":1194,"width":447,"height":42},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d4bdda27374740b6b0b4b2674372a174","type":"text","conversion_output":true,"parent_id":"c57b1ce39ba24356bd276691af49af02","text":"9.2. Inclusion Criteria","text_display":"\n\n\\subsection*{9.2. 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Subject has a documented aortic annulus size of \\(\\geq 18 mm\\) and \\(\\leq 29 mm\\) based on the center's assessment","text_display":"\nIC2. Subject has a documented aortic annulus size of \\(\\geq 18 mm\\) and \\(\\leq 29 mm\\) based on the center's assessment","confidence":1,"confidence_rate":1},{"cnt":[[404,1818],[1871,1818],[1871,1863],[404,1863]],"region":{"top_left_x":403,"top_left_y":1817,"width":1469,"height":46},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9eb5c932dde5418385c0ec32960056c1","type":"text","conversion_output":true,"text":"of pre-procedure diagnostic imaging (and confirmed by the Case Review Committee [CRC]) and, for the","text_display":" of pre-procedure diagnostic imaging (and confirmed by the Case Review Committee [CRC]) and, for the","confidence":0.99951171875,"confidence_rate":0.9999953038523912},{"cnt":[[404,1856],[1818,1856],[1818,1899],[404,1899]],"region":{"top_left_x":403,"top_left_y":1856,"width":1415,"height":44},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ea5501bf739645c19905ae7f177ca347","type":"text","conversion_output":true,"text":"randomized cohort, is deemed treatable with an available size of both test and control device. 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Subject, family member, and/or legal representative agree(s) and subject is capable of returning to the","confidence":1,"confidence_rate":1},{"cnt":[[404,1354],[1205,1354],[1205,1394],[404,1394]],"region":{"top_left_x":403,"top_left_y":1353,"width":803,"height":42},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"89af8c5af8fd40328a43dc8d3b8afcfb","type":"text","conversion_output":true,"text":"study hospital for all required scheduled follow up visits.","text_display":" study hospital for all required scheduled follow up visits.","confidence":1,"confidence_rate":1},{"cnt":[[305,1414],[1379,1414],[1379,1457],[305,1457]],"region":{"top_left_x":305,"top_left_y":1413,"width":1075,"height":44},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5069a8502c594ffda5ceb903bcf7d3a7","type":"text","conversion_output":true,"text":"Note: Extreme operative risk and high operative risk are defined as follows:","text_display":"\n\nNote: Extreme operative risk and high operative risk are defined as follows:","confidence":1,"confidence_rate":1},{"cnt":[[404,1461],[1850,1461],[1850,1506],[404,1506]],"region":{"top_left_x":403,"top_left_y":1460,"width":1447,"height":47},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1601c72e07774b12809d4ce34c0c7453","type":"text","conversion_output":true,"text":"Extreme Operative Risk: Predicted operative mortality or serious, irreversible morbidity risk \\(\\geq 50 \\%\\) at","text_display":"\nExtreme Operative Risk: Predicted operative mortality or serious, irreversible morbidity risk \\(\\geq 50 \\%\\) at","confidence":1,"confidence_rate":1},{"cnt":[[404,1504],[526,1504],[526,1549],[404,1549]],"region":{"top_left_x":403,"top_left_y":1503,"width":124,"height":47},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"04d0e91027e445eb8e532b817906e458","type":"text","conversion_output":true,"text":"30 days.","text_display":" 30 days.","confidence":1,"confidence_rate":1},{"cnt":[[404,1551],[1798,1551],[1798,1596],[404,1596]],"region":{"top_left_x":403,"top_left_y":1551,"width":1396,"height":46},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b23c2df3549d4f589284b440d9dfe4db","type":"text","conversion_output":true,"text":"High Operative Risk: Predicted operative mortality or serious, irreversible morbidity risk \\(\\geq 15 \\%\\) at","text_display":"\nHigh Operative Risk: Predicted operative mortality or serious, irreversible morbidity risk \\(\\geq 15 \\%\\) at","confidence":1,"confidence_rate":1},{"cnt":[[404,1594],[526,1594],[526,1635],[404,1635]],"region":{"top_left_x":403,"top_left_y":1594,"width":124,"height":41},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"705f0676f69744f8b4e6f5d75aa86007","type":"text","conversion_output":true,"text":"30 days.","text_display":" 30 days.","confidence":1,"confidence_rate":1},{"cnt":[[404,1641],[1785,1641],[1785,1687],[404,1687]],"region":{"top_left_x":403,"top_left_y":1641,"width":1383,"height":46},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7505688942c04205b57ae776898c45cc","type":"text","conversion_output":true,"text":"Risk of operative mortality and morbidity must be assessed via an in-person evaluation by a center","text_display":"\nRisk of operative mortality and morbidity must be assessed via an in-person evaluation by a center","confidence":0.99951171875,"confidence_rate":0.9999952582588333},{"cnt":[[404,1684],[1751,1684],[1751,1725],[404,1725]],"region":{"top_left_x":403,"top_left_y":1684,"width":1348,"height":42},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6b400617a7b8492eb5bed94a7522965b","type":"text","conversion_output":true,"text":"cardiac surgeon and must be confirmed by the CRC (which must include an experienced cardiac","text_display":" cardiac surgeon and must be confirmed by the CRC (which must include an experienced cardiac","confidence":1,"confidence_rate":1},{"cnt":[[404,1723],[544,1723],[544,1764],[404,1764]],"region":{"top_left_x":403,"top_left_y":1723,"width":141,"height":41},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"507a593cf25d46bea9ed17c243cfd702","type":"text","conversion_output":true,"text":"surgeon).","text_display":" surgeon).","confidence":1,"confidence_rate":1},{"cnt":[[305,1800],[1721,1800],[1721,1841],[305,1841]],"region":{"top_left_x":305,"top_left_y":1800,"width":1416,"height":42},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7663d1fd5e95453fa7d4f52b6cd3bcfc","type":"text","conversion_output":true,"text":"Abbreviations: AVA=aortic valve area; CRC=Clinical Review Committee; NYHA=New York Heart","text_display":"\n\nAbbreviations: AVA=aortic valve area; CRC=Clinical Review Committee; NYHA=New York Heart","confidence":0.6425217310738345,"confidence_rate":0.9952547927327028},{"cnt":[[305,1841],[990,1841],[990,1884],[305,1884]],"region":{"top_left_x":305,"top_left_y":1841,"width":686,"height":44},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ea295358309a40378fe3650c92b0bc46","type":"text","conversion_output":true,"text":"Association; STS=Society of Thoracic Surgeons","text_display":" Association; STS=Society of Thoracic Surgeons","confidence":0.9936656844829486,"confidence_rate":0.9998729188271659},{"cnt":[[303,2002],[767,2002],[767,2052],[303,2052]],"region":{"top_left_x":302,"top_left_y":2002,"width":465,"height":50},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8f2925062dc84e99b0b95ff021618bd6","type":"section_header","conversion_output":false,"children_ids":["6a547e4e01fb4ee0a505608310aa24c4"],"text":"","text_display":""},{"cnt":[[305,2004],[763,2004],[763,2047],[305,2047]],"region":{"top_left_x":305,"top_left_y":2004,"width":458,"height":44},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6a547e4e01fb4ee0a505608310aa24c4","type":"text","conversion_output":true,"parent_id":"8f2925062dc84e99b0b95ff021618bd6","text":"9.3. Exclusion Criteria","text_display":"\n\n\\subsection*{9.3. Exclusion Criteria}","confidence":0.931640625,"confidence_rate":0.997474332943668},{"cnt":[[305,2093],[1858,2093],[1858,2142],[305,2142]],"region":{"top_left_x":305,"top_left_y":2092,"width":1554,"height":50},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f000baed9b9049c290bb9f4e7f2c7d56","type":"text","conversion_output":true,"text":"Subjects who meet any one of the following criteria (Table 9.3-1) will be excluded from this","text_display":"\n\nSubjects who meet any one of the following criteria (Table 9.3-1) will be excluded from this","confidence":1,"confidence_rate":1},{"cnt":[[305,2142],[552,2142],[552,2194],[305,2194]],"region":{"top_left_x":305,"top_left_y":2141,"width":248,"height":53},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6ab3acd901bf47188a04a09b07c1b116","type":"text","conversion_output":true,"text":"clinical study.","text_display":" clinical study.","confidence":1,"confidence_rate":1},{"cnt":[[683,2230],[1504,2230],[1504,2279],[683,2279]],"region":{"top_left_x":683,"top_left_y":2230,"width":821,"height":50},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2346d25ad3d84984a0e26a8368ff6c82","type":"figure_label","conversion_output":true,"text":"Table 9.3-1: REPRISE III Exclusion Criteria","text_display":"\n\nTable 9.3-1: REPRISE III Exclusion Criteria","confidence":1,"confidence_rate":1},{"cnt":[[301,2329],[1246,2329],[1246,2374],[301,2374]],"region":{"top_left_x":300,"top_left_y":2328,"width":947,"height":47},"line":44,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8f85db813e7f4d4c9edff7a24f078b1a","type":"text","conversion_output":true,"text":"EC1. Subject has a congenital unicuspid or bicuspid aortic valve.","text_display":"\n\nEC1. Subject has a congenital unicuspid or bicuspid aortic valve.","confidence":1,"confidence_rate":1},{"cnt":[[301,2380],[1841,2380],[1841,2426],[301,2426]],"region":{"top_left_x":300,"top_left_y":2380,"width":1542,"height":46},"line":45,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4e078591a9a5448ab27162aa244ec437","type":"text","conversion_output":true,"text":"EC2. Subject has had an acute myocardial infarction within 30 days prior to the index procedure (defined as","text_display":"\nEC2. Subject has had an acute myocardial infarction within 30 days prior to the index procedure (defined as","confidence":1,"confidence_rate":1},{"cnt":[[412,2423],[1790,2423],[1790,2466],[412,2466]],"region":{"top_left_x":412,"top_left_y":2423,"width":1378,"height":44},"line":46,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b58c5a54f09947d6b00b56c32e2d22c3","type":"text","conversion_output":true,"text":"Q-wave MI or non-Q-wave MI with total CK elevation \\(\\geq\\) twice normal in the presence of CK-MB","text_display":" Q-wave MI or non-Q-wave MI with total CK elevation \\(\\geq\\) twice normal in the presence of CK-MB","confidence":0.9960982785560191,"confidence_rate":0.9999601094383394},{"cnt":[[99,2651],[312,2651],[312,2692],[99,2692]],"region":{"top_left_x":98,"top_left_y":2651,"width":214,"height":41},"line":47,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"579c0cc488af468e8698e244cd9af084","type":"page_info","conversion_output":false,"text":"Released","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[829,2655],[1296,2655],[1296,2692],[829,2692]],"region":{"top_left_x":829,"top_left_y":2655,"width":467,"height":37},"line":48,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b2de6346d1934218b50d6fa249c76308","type":"page_info","conversion_output":false,"text":"REPRISE III Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1654,2651],[1983,2651],[1983,2690],[1654,2690]],"region":{"top_left_x":1654,"top_left_y":2651,"width":330,"height":39},"line":49,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ecaee8c5e52d449c9e05891694a6f71d","type":"page_info","conversion_output":false,"text":"90899936 AK. 4","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[486,2690],[2000,2690],[2000,2731],[486,2731]],"region":{"top_left_x":485,"top_left_y":2689,"width":1516,"height":42},"line":50,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"535a1c65576748be9a15903bc736bfef","type":"page_info","conversion_output":false,"text":"Boston Scientific Confidential. 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Subject has had a cerebrovascular accident or transient ischemic attack within the past 6 months prior to","text_display":"\nEC3. Subject has had a cerebrovascular accident or transient ischemic attack within the past 6 months prior to","confidence":0.99951171875,"confidence_rate":0.9999958610212935},{"cnt":[[412,569],[664,569],[664,608],[412,608]],"region":{"top_left_x":412,"top_left_y":569,"width":252,"height":40},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ddd84840adb04812a0846cdfed1b8053","type":"text","conversion_output":true,"text":"study enrollment.","text_display":" study enrollment.","confidence":1,"confidence_rate":1},{"cnt":[[301,619],[1656,619],[1656,660],[301,660]],"region":{"top_left_x":300,"top_left_y":618,"width":1357,"height":42},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ffe0738a1c9047ef84a539edc359d271","type":"text","conversion_output":true,"text":"EC4. Subject has end-stage renal disease or has GFR \\(<20\\) (based on Cockcroft-Gault formula).","text_display":"\nEC4. Subject has end-stage renal disease or has GFR \\(<20\\) (based on Cockcroft-Gault formula).","confidence":0.993175745010376,"confidence_rate":0.9999308342435854},{"cnt":[[301,670],[1308,670],[1308,711],[301,711]],"region":{"top_left_x":300,"top_left_y":670,"width":1009,"height":42},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d921aa579bc2494cbd7629780770a04d","type":"text","conversion_output":true,"text":"EC5. Subject has a pre-existing prosthetic heart aortic or mitral valve.","text_display":"\nEC5. 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Subject has had a gastrointestinal bleed requiring hospitalization or transfusion within the past 3 months,","text_display":"\nEC12. Subject has had a gastrointestinal bleed requiring hospitalization or transfusion within the past 3 months,","confidence":0.99951171875,"confidence_rate":0.9999959636403931},{"cnt":[[415,1263],[1867,1263],[1867,1304],[415,1304]],"region":{"top_left_x":414,"top_left_y":1263,"width":1453,"height":42},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"788198bc706443eeabd6e74b5264b7b5","type":"text","conversion_output":true,"text":"or has other clinically significant bleeding diathesis or coagulopathy that would preclude treatment with","text_display":" or has other clinically significant bleeding diathesis or coagulopathy that would preclude treatment with","confidence":1,"confidence_rate":1},{"cnt":[[412,1302],[1210,1302],[1210,1343],[412,1343]],"region":{"top_left_x":412,"top_left_y":1301,"width":798,"height":42},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"02fe218e34894f36bf3449b7715f0f10","type":"text","conversion_output":true,"text":"required antiplatelet regimen, or will refuse transfusions.","text_display":" required antiplatelet regimen, or will refuse transfusions.","confidence":1,"confidence_rate":1},{"cnt":[[301,1351],[1837,1351],[1837,1394],[301,1394]],"region":{"top_left_x":300,"top_left_y":1351,"width":1537,"height":44},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"41bc6a0ac82f4e49984bb55a0e69e71b","type":"text","conversion_output":true,"text":"EC13. Subject has known hypersensitivity to contrast agents that cannot be adequately pre-medicated, or has","text_display":"\nEC13. Subject has known hypersensitivity to contrast agents that cannot be adequately pre-medicated, or has","confidence":1,"confidence_rate":1},{"cnt":[[412,1392],[1717,1392],[1717,1433],[412,1433]],"region":{"top_left_x":412,"top_left_y":1392,"width":1305,"height":42},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0418f586ccdb4123b0ab72889275562a","type":"text","conversion_output":true,"text":"known hypersensitivity to aspirin, all \\(P 2 Y _{12}\\) inhibitors, heparin, nickel, tantalum, titanium, or","text_display":" known hypersensitivity to aspirin, all \\(P 2 Y _{12}\\) inhibitors, heparin, nickel, tantalum, titanium, or","confidence":0.831793702673167,"confidence_rate":0.9984271286673312},{"cnt":[[412,1431],[621,1431],[621,1474],[412,1474]],"region":{"top_left_x":412,"top_left_y":1430,"width":209,"height":44},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3fc7d5060ce644c69cf99c0b3cbf469d","type":"text","conversion_output":true,"text":"polyurethanes.","text_display":" polyurethanes.","confidence":1,"confidence_rate":1},{"cnt":[[301,1482],[1850,1482],[1850,1523],[301,1523]],"region":{"top_left_x":300,"top_left_y":1482,"width":1550,"height":42},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d607b338f9674e65a0b485551d3c609e","type":"text","conversion_output":true,"text":"EC14. Subject has a life expectancy of less than 12 months due to non-cardiac, comorbid conditions based on","text_display":"\nEC14. 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Subjects who are enrolled but do not receive a study","text_display":" Visits must be an office/clinical visit, but may be done in-hospital should the subject be admitted at the time. 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In the United States, the Centers for Medicare and Medicaid Services require independent evaluations by","confidence":1,"confidence_rate":1},{"cnt":[[292,846],[806,846],[806,885],[292,885]],"region":{"top_left_x":292,"top_left_y":846,"width":514,"height":40},"line":59,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0ea9f713e1014e44a7d054515653ff9b","type":"text","conversion_output":true,"text":"2 cardiac surgeons for reimbursement.","text_display":" 2 cardiac surgeons for reimbursement.","confidence":1,"confidence_rate":1},{"cnt":[[245,887],[2443,887],[2443,926],[245,926]],"region":{"top_left_x":244,"top_left_y":887,"width":2199,"height":39},"line":60,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e0b4ef548ede45e0a0dcddfdb9fe4158","type":"text","conversion_output":true,"text":"h: Frailty, disability, and comorbidity risk assessments must be captured at screening: height, weight, cognitive function (Mini-Cognitive Assessment for Dementia),","text_display":"\nh: Frailty, disability, and comorbidity risk assessments must be captured at screening: height, weight, cognitive function (Mini-Cognitive Assessment for Dementia),","confidence":0.99951171875,"confidence_rate":0.9999971100604},{"cnt":[[294,924],[2481,924],[2481,965],[294,965]],"region":{"top_left_x":294,"top_left_y":923,"width":2188,"height":42},"line":61,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"72a9cb9d9b234300b2a737ca6f4f7207","type":"text","conversion_output":true,"text":"strength and balance (use of wheelchair, gait speed to walk 5 meters, number of falls in the past 6 months, maximal grip strength), and activities of daily living (Katz","text_display":" strength and balance (use of wheelchair, gait speed to walk 5 meters, number of falls in the past 6 months, maximal grip strength), and activities of daily living (Katz","confidence":1,"confidence_rate":1},{"cnt":[[292,962],[1214,962],[1214,1003],[292,1003]],"region":{"top_left_x":292,"top_left_y":962,"width":922,"height":42},"line":62,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"cb286f26638d47aa818c87c33ac6e41a","type":"text","conversion_output":true,"text":"Index); at 1 year, gait speed to walk 5 meters must be assessed again.","text_display":" Index); at 1 year, gait speed to walk 5 meters must be assessed again.","confidence":1,"confidence_rate":1},{"cnt":[[245,1005],[2477,1005],[2477,1044],[245,1044]],"region":{"top_left_x":244,"top_left_y":1005,"width":2234,"height":40},"line":63,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b23c019449f84f7b875c0644e4078c1b","type":"text","conversion_output":true,"text":"i: Transthoracic echocardiogram (TTE) is required for all subjects who have a valve implanted in the aortic position. This includes assessment of EOA, peak and mean","text_display":"\ni: Transthoracic echocardiogram (TTE) is required for all subjects who have a valve implanted in the aortic position. This includes assessment of EOA, peak and mean","confidence":0.9990234375,"confidence_rate":0.9999942187170204},{"cnt":[[292,1044],[2378,1044],[2378,1083],[292,1083]],"region":{"top_left_x":292,"top_left_y":1044,"width":2087,"height":39},"line":64,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"790605327dac4530a1c3af178cdd6a33","type":"text","conversion_output":true,"text":"aortic valve pressure gradients, aortic regurgitation assessment, and LVEF. Screening TTE must be performed within 60 days prior to CRC review. At least 1","text_display":" aortic valve pressure gradients, aortic regurgitation assessment, and LVEF. Screening TTE must be performed within 60 days prior to CRC review. At least 1","confidence":1,"confidence_rate":1},{"cnt":[[292,1079],[2426,1079],[2426,1119],[292,1119]],"region":{"top_left_x":292,"top_left_y":1078,"width":2134,"height":42},"line":65,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8f1d849d518a4104af74769c30da9d28","type":"text","conversion_output":true,"text":"echocardiogram must be obtained before discharge or 7 days (whichever comes first); if multiple echocardiographic studies are performed prior to discharge and","text_display":" echocardiogram must be obtained before discharge or 7 days (whichever comes first); if multiple echocardiographic studies are performed prior to discharge and","confidence":1,"confidence_rate":1},{"cnt":[[292,1117],[2486,1117],[2486,1158],[292,1158]],"region":{"top_left_x":292,"top_left_y":1117,"width":2194,"height":42},"line":66,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"883f6d4001f345c89d16cd6835d248e3","type":"text","conversion_output":true,"text":"within 7 days of the procedure, the latest study performed will be used for analysis. All TTEs must be performed according to the Echocardiography Core Laboratory","text_display":" within 7 days of the procedure, the latest study performed will be used for analysis. All TTEs must be performed according to the Echocardiography Core Laboratory","confidence":1,"confidence_rate":1},{"cnt":[[292,1156],[2151,1156],[2151,1197],[292,1197]],"region":{"top_left_x":292,"top_left_y":1155,"width":1859,"height":42},"line":67,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e49fd361dee44b90996ee516d9283cdb","type":"text","conversion_output":true,"text":"procedure guidelines (see study Manual of Operations). If a subject does not receive an implanted valve, then no follow-up TTE is required.","text_display":" procedure guidelines (see study Manual of Operations). If a subject does not receive an implanted valve, then no follow-up TTE is required.","confidence":1,"confidence_rate":1},{"cnt":[[292,1195],[2503,1195],[2503,1233],[292,1233]],"region":{"top_left_x":292,"top_left_y":1194,"width":2211,"height":40},"line":68,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"deb0ce5c82f9443aa24eb8b2734948e1","type":"text","conversion_output":true,"text":"Note: In cases of low flow low gradient aortic stenosis, dobutamine can be used to assess the grade of aortic stenosis; the subject may be enrolled if echocardiographic","text_display":"\nNote: In cases of low flow low gradient aortic stenosis, dobutamine can be used to assess the grade of aortic stenosis; the subject may be enrolled if echocardiographic","confidence":1,"confidence_rate":1},{"cnt":[[292,1233],[2494,1233],[2494,1272],[292,1272]],"region":{"top_left_x":292,"top_left_y":1233,"width":2203,"height":39},"line":69,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"798adee047454e0a8e731acf9337f8be","type":"text","conversion_output":true,"text":"criteria are met with this augmentation. In cases where a subject who has met the echocardiographic criteria for enrollment receives BAV prior to the index procedure","text_display":" criteria are met with this augmentation. In cases where a subject who has met the echocardiographic criteria for enrollment receives BAV prior to the index procedure","confidence":0.99951171875,"confidence_rate":0.9999971270600203},{"cnt":[[292,1270],[2331,1270],[2331,1308],[292,1308]],"region":{"top_left_x":292,"top_left_y":1269,"width":2040,"height":40},"line":70,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"de68f2b1e65248cb8556ac7562967f5b","type":"text","conversion_output":true,"text":"and subsequently no longer meets the REPRISE III aortic valve pressure gradient or EOA criteria, the subject may still be enrolled based on the pre-BAV","text_display":" and subsequently no longer meets the REPRISE III aortic valve pressure gradient or EOA criteria, the subject may still be enrolled based on the pre-BAV","confidence":1,"confidence_rate":1},{"cnt":[[292,1308],[2288,1308],[2288,1347],[292,1347]],"region":{"top_left_x":292,"top_left_y":1308,"width":1997,"height":40},"line":71,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"14611ddf962d446dac9e7cc50e6d0a56","type":"text","conversion_output":true,"text":"echocardiographic data. In such cases, the most recent echocardiogram done prior to the index procedure (even if after BAV) must be submitted to the","text_display":" echocardiographic data. In such cases, the most recent echocardiogram done prior to the index procedure (even if after BAV) must be submitted to the","confidence":1,"confidence_rate":1},{"cnt":[[292,1345],[1235,1345],[1235,1386],[292,1386]],"region":{"top_left_x":292,"top_left_y":1344,"width":944,"height":42},"line":72,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"57dd339fa3ad4c27a721751370972b61","type":"text","conversion_output":true,"text":"Echocardiography Core Laboratory to be included in the baseline data.","text_display":" Echocardiography Core Laboratory to be included in the baseline data.","confidence":1,"confidence_rate":1},{"cnt":[[243,1388],[1205,1388],[1205,1429],[243,1429]],"region":{"top_left_x":242,"top_left_y":1387,"width":964,"height":42},"line":73,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b0219d1a3d4f4e31aa80523faf4ffbdc","type":"text","conversion_output":true,"text":"j : TEE is recommended but not required during the implant procedure.","text_display":"\nj : TEE is recommended but not required during the implant procedure.","confidence":0.6170868873596191,"confidence_rate":0.9936682170388409},{"cnt":[[245,1429],[2451,1429],[2451,1467],[245,1467]],"region":{"top_left_x":244,"top_left_y":1428,"width":2208,"height":40},"line":74,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2f07345df667476a91b8422de44ac06c","type":"text","conversion_output":true,"text":"k : A coronary angiogram must be performed within 365 days prior to CRC review. If there is concern regarding the current extent of coronary artery disease or aortic","text_display":"\nk : A coronary angiogram must be performed within 365 days prior to CRC review. If there is concern regarding the current extent of coronary artery disease or aortic","confidence":0.79833984375,"confidence_rate":0.9987138512116222},{"cnt":[[292,1465],[1386,1465],[1386,1506],[292,1506]],"region":{"top_left_x":292,"top_left_y":1465,"width":1094,"height":42},"line":75,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c7f9788eec14453eac85e92dacc3e9a6","type":"text","conversion_output":true,"text":"stenosis, the CRC may recommend a repeat study closer to the time of enrollment.","text_display":" stenosis, the CRC may recommend a repeat study closer to the time of enrollment.","confidence":1,"confidence_rate":1},{"cnt":[[245,1508],[2477,1508],[2477,1549],[245,1549]],"region":{"top_left_x":244,"top_left_y":1508,"width":2234,"height":42},"line":76,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0d089bb28c904d5f9cb6dd61444718ca","type":"text","conversion_output":true,"text":"1: A CT angiogram of the aortic complex must be performed within 180 days prior to CRC review (and should be performed within 90 days if possible) to evaluate the","text_display":"\n1: A CT angiogram of the aortic complex must be performed within 180 days prior to CRC review (and should be performed within 90 days if possible) to evaluate the","confidence":1,"confidence_rate":1},{"cnt":[[292,1547],[2499,1547],[2499,1588],[292,1588]],"region":{"top_left_x":292,"top_left_y":1546,"width":2207,"height":42},"line":77,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b246060793494c73b13683f2709cb0e3","type":"text","conversion_output":true,"text":"aortic valve anatomy and aortic root dimensions for device sizing. CT angiogram must be performed according to the CT/X-ray Core Laboratory procedure guidelines","text_display":" aortic valve anatomy and aortic root dimensions for device sizing. CT angiogram must be performed according to the CT/X-ray Core Laboratory procedure guidelines","confidence":1,"confidence_rate":1},{"cnt":[[292,1586],[2499,1586],[2499,1624],[292,1624]],"region":{"top_left_x":292,"top_left_y":1585,"width":2207,"height":40},"line":78,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bffb7de842a04906accd441088d82dab","type":"text","conversion_output":true,"text":"(see study Manual of Operations). It must be sent to the Core Laboratory for detailed measurements and analyses in advance of the CRC meeting where results will be","text_display":" (see study Manual of Operations). It must be sent to the Core Laboratory for detailed measurements and analyses in advance of the CRC meeting where results will be","confidence":1,"confidence_rate":1},{"cnt":[[292,1622],[836,1622],[836,1661],[292,1661]],"region":{"top_left_x":292,"top_left_y":1622,"width":544,"height":39},"line":79,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"fde7cc2b6d554e6cbd5a85013c5e7e92","type":"text","conversion_output":true,"text":"reviewed to confirm subject's eligibility.","text_display":" reviewed to confirm subject's eligibility.","confidence":0.99951171875,"confidence_rate":0.9999896085540316},{"cnt":[[245,1663],[2400,1663],[2400,1704],[245,1704]],"region":{"top_left_x":244,"top_left_y":1662,"width":2156,"height":42},"line":80,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0d6c7be1c01e4fada2076ecf3e9d322a","type":"text","conversion_output":true,"text":"m : An assessment of the iliofemoral system must be performed within 180 days prior to CRC review (and should be performed within 90 days if possible). A CT","text_display":"\nm : An assessment of the iliofemoral system must be performed within 180 days prior to CRC review (and should be performed within 90 days if possible). A CT","confidence":0.620065655397184,"confidence_rate":0.997176007352664},{"cnt":[[292,1702],[2374,1702],[2374,1742],[292,1742]],"region":{"top_left_x":292,"top_left_y":1701,"width":2083,"height":42},"line":81,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b51945e784b44d64a03a1dbce191f8da","type":"text","conversion_output":true,"text":"angiogram of the iliofemoral system should be performed for complete visualization of the iliac and femoral arteries to assess for dimensions, tortuosity, and","text_display":" angiogram of the iliofemoral system should be performed for complete visualization of the iliac and femoral arteries to assess for dimensions, tortuosity, and","confidence":0.9990234375,"confidence_rate":0.9999940059096958},{"cnt":[[292,1740],[2438,1740],[2438,1779],[292,1779]],"region":{"top_left_x":292,"top_left_y":1740,"width":2147,"height":39},"line":82,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"14d4f67abebd461e931e048c96b0fd9f","type":"text","conversion_output":true,"text":"calcification. The CT angiogram should be performed per the procedure guidelines (see study Manual of Operations) and sent to the CT Core Laboratory with the","text_display":" calcification. The CT angiogram should be performed per the procedure guidelines (see study Manual of Operations) and sent to the CT Core Laboratory with the","confidence":1,"confidence_rate":1},{"cnt":[[292,1779],[2110,1779],[2110,1818],[292,1818]],"region":{"top_left_x":292,"top_left_y":1778,"width":1818,"height":40},"line":83,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3955d3dffe2b4b46b34e404453b29f05","type":"text","conversion_output":true,"text":"screening CT angiogram of the aortic structure. An iliofemoral invasive angiogram may be substituted for the iliofemoral CT angiogram.","text_display":" screening CT angiogram of the aortic structure. An iliofemoral invasive angiogram may be substituted for the iliofemoral CT angiogram.","confidence":1,"confidence_rate":1},{"cnt":[[245,1818],[2447,1818],[2447,1858],[245,1858]],"region":{"top_left_x":244,"top_left_y":1817,"width":2204,"height":42},"line":84,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4f521a8974514bba9b7a53eb5daae383","type":"text","conversion_output":true,"text":"n: Annual imaging using rotational x-ray to assess for structural valve frame integrity must be performed on subjects who receive the Lotus Valve. Please refer to the","text_display":"\nn: Annual imaging using rotational x-ray to assess for structural valve frame integrity must be performed on subjects who receive the Lotus Valve. 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Results must be forwarded to the CT/X-Ray Core Laboratory for analysis. If","text_display":"\n\nImaging Core Laboratory procedure guidelines (see study Manual of Operations). Results must be forwarded to the CT/X-Ray Core Laboratory for analysis. 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Baseline QOLs should be performed within 30 days prior to the index procedure.","text_display":"\no: Includes the Kansas City Cardiomyopathy and SF-12 QOL questionnaires. Baseline QOLs should be performed within 30 days prior to the index procedure.","confidence":1,"confidence_rate":1},{"cnt":[[245,730],[746,730],[746,769],[245,769]],"region":{"top_left_x":244,"top_left_y":730,"width":502,"height":40},"line":56,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8496f856933a4e0fba54218e6e7cbc05","type":"text","conversion_output":true,"text":"p: QOL survey at 36 and 60 months.","text_display":"\np: QOL survey at 36 and 60 months.","confidence":0.9921989440917969,"confidence_rate":0.9998259786251477},{"cnt":[[245,773],[2460,773],[2460,812],[245,812]],"region":{"top_left_x":244,"top_left_y":773,"width":2216,"height":40},"line":57,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5a7d141c89584ec684b14ff9ccb8a3c7","type":"text","conversion_output":true,"text":"q : Procedural cine-angiogram including final post-deployment aortogram of the ascending aorta must be done and sent to the CT/X-Ray Core Laboratory for analysis.","text_display":"\nq : Procedural cine-angiogram including final post-deployment aortogram of the ascending aorta must be done and sent to the CT/X-Ray Core Laboratory for analysis.","confidence":0.89794921875,"confidence_rate":0.9993632692987572},{"cnt":[[245,812],[2400,812],[2400,853],[245,853]],"region":{"top_left_x":244,"top_left_y":812,"width":2156,"height":41},"line":58,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"944cea8d2efb4f9a957cadff1f448beb","type":"text","conversion_output":true,"text":"r: For subjects who received a permanent pacemaker related to the index procedure, pacemaker dependence must be captured at the 30 -day and 1 -year visits via","text_display":"\nr: For subjects who received a permanent pacemaker related to the index procedure, pacemaker dependence must be captured at the 30 -day and 1 -year visits via","confidence":0.9501393225513084,"confidence_rate":0.99969740289338},{"cnt":[[292,851],[2142,851],[2142,892],[292,892]],"region":{"top_left_x":292,"top_left_y":850,"width":1850,"height":42},"line":59,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"03b38058e1a745aa8642a76841db8a08","type":"text","conversion_output":true,"text":"pacemaker interrogation. Pacemaker interrogation should also include assessment of the percentage of beats where the ventricles are paced.","text_display":" pacemaker interrogation. Pacemaker interrogation should also include assessment of the percentage of beats where the ventricles are paced.","confidence":1,"confidence_rate":1},{"cnt":[[245,894],[2481,894],[2481,930],[245,930]],"region":{"top_left_x":244,"top_left_y":893,"width":2238,"height":38},"line":60,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1fbbcc8443dc4058b64a6c2768268a00","type":"text","conversion_output":true,"text":"s: AEs and ADEs will be monitored and collected from the time of enrollment through 12 -month follow-up. For subjects who do not receive the study device, AEs will","text_display":"\ns: AEs and ADEs will be monitored and collected from the time of enrollment through 12 -month follow-up. 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For subjects who do not receive a study device","text_display":" reported to Boston Scientific for all enrolled subjects from the time of enrollment through termination of the study. For subjects who do not receive a study device","confidence":1,"confidence_rate":1},{"cnt":[[292,1048],[2494,1048],[2494,1085],[292,1085]],"region":{"top_left_x":292,"top_left_y":1048,"width":2203,"height":37},"line":64,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"96ba241fcef14493bf6ce127af29671d","type":"text","conversion_output":true,"text":"(test or control), the mentioned events will be monitored through 1 year post-index procedure. Please refer to Section 7.2 for a list of CEC events and Table 26.2-1 for","text_display":" (test or control), the mentioned events will be monitored through 1 year post-index procedure. 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Complaint reporting of any device deficiencies for any commercially available products","confidence":1,"confidence_rate":1},{"cnt":[[292,1124],[1188,1124],[1188,1162],[292,1162]],"region":{"top_left_x":292,"top_left_y":1123,"width":897,"height":40},"line":66,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2f37af136fa7499ca6399f9687026dda","type":"text","conversion_output":true,"text":"used should also be carried out using the manufacturer's processes.","text_display":" used should also be carried out using the manufacturer's processes.","confidence":1,"confidence_rate":1},{"cnt":[[245,1164],[2434,1164],[2434,1205],[245,1205]],"region":{"top_left_x":244,"top_left_y":1164,"width":2191,"height":42},"line":67,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4deaa2975fa349c89486cd9965532d84","type":"text","conversion_output":true,"text":"u: This applies to subjects in the CT Imaging Substudy of the U.S. Continued Access Study. 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Device preparation should only be performed by persons who have","confidence":0.9014151096343994,"confidence_rate":0.9988212701750044},{"cnt":[[309,602],[1852,602],[1852,647],[309,647]],"region":{"top_left_x":309,"top_left_y":601,"width":1543,"height":46},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9c36d8a3680648cf901eb37204880806","type":"text","conversion_output":true,"text":"completed appropriate training with the Lotus Valve System or LOTUS Edge Valve System","text_display":" completed appropriate training with the Lotus Valve System or LOTUS Edge Valve System","confidence":1,"confidence_rate":1},{"cnt":[[309,649],[569,649],[569,696],[309,696]],"region":{"top_left_x":309,"top_left_y":648,"width":261,"height":49},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bc245c60a7414fd9b778439240b52fec","type":"text","conversion_output":true,"text":"(as applicable).","text_display":" (as applicable).","confidence":1,"confidence_rate":1},{"cnt":[[309,718],[1815,718],[1815,765],[309,765]],"region":{"top_left_x":309,"top_left_y":717,"width":1507,"height":48},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"66b9e442c29748d082e40e992603448b","type":"text","conversion_output":true,"text":"Prior to insertion of the Lotus Valve System/LOTUS Edge Valve System catheter into the","text_display":"\n\nPrior to insertion of the Lotus Valve System/LOTUS Edge Valve System catheter into the","confidence":0.9960954189300537,"confidence_rate":0.9999570094532666},{"cnt":[[309,765],[1841,765],[1841,814],[309,814]],"region":{"top_left_x":309,"top_left_y":764,"width":1533,"height":51},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2cfb2b6a34174c6a963fe3fad46cdeb4","type":"text","conversion_output":true,"text":"Lotus Introducer, the recommended target ACT of \\(\\geq 250\\) seconds should be confirmed, with","text_display":" Lotus Introducer, the recommended target ACT of \\(\\geq 250\\) seconds should be confirmed, with","confidence":1,"confidence_rate":1},{"cnt":[[309,812],[1197,812],[1197,862],[309,862]],"region":{"top_left_x":309,"top_left_y":812,"width":888,"height":50},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7a199a5729f64e328d4fa1760411203c","type":"text","conversion_output":true,"text":"additional boluses of heparin administered if needed.","text_display":" additional boluses of heparin administered if needed.","confidence":1,"confidence_rate":1},{"cnt":[[309,881],[1721,881],[1721,930],[309,930]],"region":{"top_left_x":309,"top_left_y":880,"width":1412,"height":51},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fec682bb562c49c89950af8a498edcf4","type":"text","conversion_output":true,"text":"The Lotus Valve System or LOTUS Edge Valve System IFU should be followed, as","text_display":"\n\nThe Lotus Valve System or LOTUS Edge Valve System IFU should be followed, as","confidence":1,"confidence_rate":1},{"cnt":[[309,930],[1858,930],[1858,978],[309,978]],"region":{"top_left_x":309,"top_left_y":930,"width":1550,"height":48},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c0b87ee373614e65ab6358a01a5e5461","type":"text","conversion_output":true,"text":"applicable. The following summarizes the Lotus Valve System/ LOTUS Edge Valve System","text_display":" applicable. The following summarizes the Lotus Valve System/ LOTUS Edge Valve System","confidence":0.9990236759185791,"confidence_rate":0.999989024768136},{"cnt":[[309,975],[492,975],[492,1025],[309,1025]],"region":{"top_left_x":309,"top_left_y":975,"width":183,"height":50},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d0dac661b8f847d9828828f8a93dd712","type":"text","conversion_output":true,"text":"procedure.","text_display":" procedure.","confidence":1,"confidence_rate":1},{"cnt":[[312,1044],[1777,1044],[1777,1094],[312,1094]],"region":{"top_left_x":311,"top_left_y":1044,"width":1466,"height":50},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b61ff82ff08f4d2d89d8e6fb90921e02","type":"text","conversion_output":true,"text":"1) The Lotus/LOTUS Edge delivery catheter is back-loaded onto a 0.035 in ( 0.89 mm )","text_display":"\n1) The Lotus/LOTUS Edge delivery catheter is back-loaded onto a 0.035 in ( 0.89 mm )","confidence":0.9956109506310895,"confidence_rate":0.999954653507334},{"cnt":[[372,1096],[1841,1096],[1841,1143],[372,1143]],"region":{"top_left_x":371,"top_left_y":1095,"width":1471,"height":48},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d41c3e76c35d4afda1cc14e64a0685e6","type":"text","conversion_output":true,"text":"Super/Extra Stiff guidewire, maintaining proper guidewire positioning across the native","text_display":" Super/Extra Stiff guidewire, maintaining proper guidewire positioning across the native","confidence":1,"confidence_rate":1},{"cnt":[[372,1143],[840,1143],[840,1184],[372,1184]],"region":{"top_left_x":371,"top_left_y":1142,"width":470,"height":42},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"778db77863994ae687ea1db517935c2e","type":"text","conversion_output":true,"text":"valve and into the ventricle.","text_display":" valve and into the ventricle.","confidence":1,"confidence_rate":1},{"cnt":[[309,1212],[1738,1212],[1738,1259],[309,1259]],"region":{"top_left_x":309,"top_left_y":1211,"width":1430,"height":48},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"534f7275183d4f1aa8407f325911ab39","type":"text","conversion_output":true,"text":"2) The Lotus/LOTUS Edge catheter is inserted in the Lotus Introducer and carefully","text_display":"\n2) The Lotus/LOTUS Edge catheter is inserted in the Lotus Introducer and carefully","confidence":1,"confidence_rate":1},{"cnt":[[372,1259],[1472,1259],[1472,1308],[372,1308]],"region":{"top_left_x":371,"top_left_y":1258,"width":1101,"height":51},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dca174aa4e0a4776acf9e8db1a56979e","type":"text","conversion_output":true,"text":"advanced through the aorta and the aortic arch under fluoroscopy.","text_display":" advanced through the aorta and the aortic arch under fluoroscopy.","confidence":1,"confidence_rate":1},{"cnt":[[309,1328],[1764,1328],[1764,1377],[309,1377]],"region":{"top_left_x":309,"top_left_y":1327,"width":1455,"height":51},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2cac745b7e364765affa1920995e513e","type":"text","conversion_output":true,"text":"3) The catheter is then advanced slowly through the aortic annulus. The valve is then","text_display":"\n3) The catheter is then advanced slowly through the aortic annulus. The valve is then","confidence":0.998046875,"confidence_rate":0.9999782776266475},{"cnt":[[387,1375],[1207,1375],[1207,1424],[387,1424]],"region":{"top_left_x":386,"top_left_y":1375,"width":822,"height":50},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6b8a3d1222a64aa2bf49752e07511906","type":"text","conversion_output":true,"text":"mechanically expanded into the desired position.","text_display":" mechanically expanded into the desired position.","confidence":1,"confidence_rate":1},{"cnt":[[309,1444],[1734,1444],[1734,1493],[309,1493]],"region":{"top_left_x":309,"top_left_y":1443,"width":1425,"height":51},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"73d1b73005054cabaf39bed617d5e122","type":"text","conversion_output":true,"text":"4) Prior to the release of the Lotus Valve, assessment of its position and function is","text_display":"\n4) Prior to the release of the Lotus Valve, assessment of its position and 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valve is then","confidence":0.9990234375,"confidence_rate":0.9999897154250147},{"cnt":[[387,1609],[1783,1609],[1783,1656],[387,1656]],"region":{"top_left_x":386,"top_left_y":1609,"width":1398,"height":48},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"35213328aba54004a853cd33820f8995","type":"text","conversion_output":true,"text":"partially or completely resheathed inside the catheter, with a repositioning made by","text_display":" partially or completely resheathed inside the catheter, with a repositioning made by","confidence":1,"confidence_rate":1},{"cnt":[[387,1656],[1850,1656],[1850,1704],[387,1704]],"region":{"top_left_x":386,"top_left_y":1656,"width":1464,"height":48},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d1ed4714ee8d4e948a0fbb5b63bb760e","type":"text","conversion_output":true,"text":"either pulling or pushing the catheter carefully, using the radiopaque marker as a guide.","text_display":" either pulling or pushing the catheter carefully, using the radiopaque marker as a guide.","confidence":1,"confidence_rate":1},{"cnt":[[387,1706],[986,1706],[986,1751],[387,1751]],"region":{"top_left_x":386,"top_left_y":1705,"width":601,"height":46},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c04a437ed8a249feb3a584be3341eb22","type":"text","conversion_output":true,"text":"The valve can then be re-expanded.","text_display":" The valve can then be re-expanded.","confidence":1,"confidence_rate":1},{"cnt":[[309,1775],[1839,1775],[1839,1824],[309,1824]],"region":{"top_left_x":309,"top_left_y":1774,"width":1531,"height":51},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"341c44359190436aa6c274eba4daa0f2","type":"text","conversion_output":true,"text":"6) Once the Lotus Valve position is deemed satisfactory and the valve is fully locked, the","text_display":"\n6) Once the Lotus Valve position is deemed satisfactory and the valve is fully locked, the","confidence":1,"confidence_rate":1},{"cnt":[[387,1822],[1760,1822],[1760,1869],[387,1869]],"region":{"top_left_x":386,"top_left_y":1821,"width":1374,"height":49},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8661f0cefd09468ba075eedca31c675d","type":"text","conversion_output":true,"text":"release process is then initiated and the Lotus Valve is detached from the catheter.","text_display":" release process is then initiated and the Lotus Valve is detached from the catheter.","confidence":1,"confidence_rate":1},{"cnt":[[309,1891],[1493,1891],[1493,1940],[309,1940]],"region":{"top_left_x":309,"top_left_y":1890,"width":1185,"height":51},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"18c022947dad420096ef330c8eeadaff","type":"text","conversion_output":true,"text":"7) The nosecone is recaptured and the system pulled out of the body.","text_display":"\n7) The nosecone is recaptured and the 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and time of vascular closure (skin-to-skin","confidence":1,"confidence_rate":1},{"cnt":[[400,700],[501,700],[501,746],[400,746]],"region":{"top_left_x":399,"top_left_y":700,"width":102,"height":46},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d532f3dd2f0c4a79aa9d0711d63081ef","type":"text","conversion_output":true,"text":"time)","text_display":" time)","confidence":1,"confidence_rate":1},{"cnt":[[339,769],[1147,769],[1147,814],[339,814]],"region":{"top_left_x":339,"top_left_y":769,"width":809,"height":46},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"42d4c1dee44042c787a6b5a92f4845f3","type":"text","conversion_output":true,"text":"- Lotus Introducer insertion and removal time","text_display":"\n- Lotus Introducer insertion and removal 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rhythm strip should be recorded (12-lead","confidence":1,"confidence_rate":1},{"cnt":[[400,1079],[767,1079],[767,1130],[400,1130]],"region":{"top_left_x":399,"top_left_y":1078,"width":368,"height":53},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5312a8780e0b4efbacebd79fbd4fc680","type":"text","conversion_output":true,"text":"ECG is not required).","text_display":" ECG is not required).","confidence":0.9970703125,"confidence_rate":0.9998871606962645},{"cnt":[[339,1152],[1880,1152],[1880,1203],[339,1203]],"region":{"top_left_x":339,"top_left_y":1151,"width":1541,"height":53},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b420da5c64d74bdbbaedfa82cd39119f","type":"text","conversion_output":true,"text":"- Lotus Valve System or LOTUS Edge Valve System catheter insertion and removal time","text_display":"\n- Lotus Valve System or LOTUS Edge Valve System catheter insertion and removal 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Post-Procedure","text_display":"\n\n\\subsection*{11.8. Post-Procedure}","confidence":1,"confidence_rate":1},{"cnt":[[305,1904],[1162,1904],[1162,1953],[305,1953]],"region":{"top_left_x":305,"top_left_y":1903,"width":858,"height":50},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5fceb109d0894c829d41214b77c977b4","type":"text","conversion_output":true,"text":"The following are to be performed post-procedure.","text_display":"\n\nThe following are to be performed post-procedure.","confidence":1,"confidence_rate":1},{"cnt":[[339,1977],[1721,1977],[1721,2026],[339,2026]],"region":{"top_left_x":339,"top_left_y":1976,"width":1382,"height":50},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0c235b1c404d491e92afe396e4e77cd4","type":"text","conversion_output":true,"text":"- Per society guidelines, antiplatelet therapy with aspirin and a thienopyridine is","text_display":"\n- Per society guidelines, antiplatelet therapy with aspirin and a thienopyridine is","confidence":1,"confidence_rate":1},{"cnt":[[400,2024],[1803,2024],[1803,2073],[400,2073]],"region":{"top_left_x":399,"top_left_y":2023,"width":1404,"height":51},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e5bdd18c12f645ec8f3a7cc22876530c","type":"text","conversion_output":true,"text":"recommended to reduce the risk of thrombotic or thromboembolic complications if","text_display":" recommended to reduce the risk of thrombotic or thromboembolic complications if","confidence":1,"confidence_rate":1},{"cnt":[[400,2065],[1830,2065],[1830,2121],[400,2121]],"region":{"top_left_x":399,"top_left_y":2064,"width":1432,"height":57},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d7f336e89f874682ac0f19536794dc54","type":"text","conversion_output":true,"text":"there are no contraindications to these medications \\({ }^{8,115}\\). Subjects must be treated with","text_display":" there are no contraindications to these medications \\({ }^{8,115}\\). Subjects must be treated with","confidence":1,"confidence_rate":1},{"cnt":[[400,2118],[1807,2118],[1807,2168],[400,2168]],"region":{"top_left_x":399,"top_left_y":2118,"width":1408,"height":50},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"28fa885fd5be4b08b8dcc684ced79e08","type":"text","conversion_output":true,"text":"aspirin and clopidogrel for at least 1 month following valve implantation. Extended","text_display":" aspirin and clopidogrel for at least 1 month following valve implantation. 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It is recommended that daily aspirin be given","text_display":" must be given for at least 1 month. It is recommended that daily aspirin be given","confidence":1,"confidence_rate":1},{"cnt":[[460,2331],[1869,2331],[1869,2383],[460,2383]],"region":{"top_left_x":459,"top_left_y":2331,"width":1411,"height":52},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8d66f83080d04535911eb61110e9abfe","type":"text","conversion_output":true,"text":"indefinitely thereafter as per local standard of care. Aspirin dose may be adjusted to","text_display":" indefinitely thereafter as per local standard of care. 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Test the primary safety endpoint (Section 12.1.1) and the primary hypothesis of the","text_display":"\n1. Test the primary safety endpoint (Section 12.1.1) and the primary hypothesis of the","confidence":0.99951171875,"confidence_rate":0.9999946329759618},{"cnt":[[402,2187],[1783,2187],[1783,2237],[402,2237]],"region":{"top_left_x":401,"top_left_y":2187,"width":1383,"height":50},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"85b0ec5b56734ebdbb7cb529de5aa053","type":"text","conversion_output":true,"text":"primary effectiveness endpoint (Section 12.1.2.1.1). If the null hypothesis for both","text_display":" primary effectiveness endpoint (Section 12.1.2.1.1). If the null hypothesis for both","confidence":0.99853515625,"confidence_rate":0.9999835291504493},{"cnt":[[404,2234],[1764,2234],[1764,2284],[404,2284]],"region":{"top_left_x":403,"top_left_y":2234,"width":1361,"height":50},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"57b9e10f03474671a469745cac52e660","type":"text","conversion_output":true,"text":"endpoints is rejected to show non-inferiority of the Lotus group to the CoreValve","text_display":" endpoints is rejected to show non-inferiority of the Lotus group to the CoreValve","confidence":1,"confidence_rate":1},{"cnt":[[404,2282],[902,2282],[902,2331],[404,2331]],"region":{"top_left_x":403,"top_left_y":2281,"width":500,"height":51},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"335c014a79154675bad06528b2208349","type":"text","conversion_output":true,"text":"group, then proceed to step 2.","text_display":" group, then proceed to step 2.","confidence":1,"confidence_rate":1},{"cnt":[[357,2350],[1852,2350],[1852,2400],[357,2400]],"region":{"top_left_x":356,"top_left_y":2350,"width":1496,"height":50},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e0453a3d335044f9b08ca00cabbe4188","type":"text","conversion_output":true,"text":"2. 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Primary Safety Endpoint","text_display":"\n\n\\subsection*{12.1.1. Primary Safety Endpoint}","confidence":1,"confidence_rate":1},{"cnt":[[307,567],[1841,567],[1841,617],[307,617]],"region":{"top_left_x":307,"top_left_y":567,"width":1535,"height":50},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c152291863df4ffaafdff5094f4960fe","type":"text","conversion_output":true,"text":"The primary safety endpoint is the composite of all-cause mortality, stroke, life-threatening","text_display":"\n\nThe primary safety endpoint is the composite of all-cause mortality, stroke, life-threatening","confidence":1,"confidence_rate":1},{"cnt":[[305,614],[1858,614],[1858,664],[305,664]],"region":{"top_left_x":305,"top_left_y":614,"width":1554,"height":50},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4e16d62c60d14e6e9f63d9724bac2ccd","type":"text","conversion_output":true,"text":"and major bleeding events, stage 2 or 3 acute kidney injury, or major vascular complications","text_display":" and major bleeding events, stage 2 or 3 acute kidney injury, or major vascular complications","confidence":1,"confidence_rate":1},{"cnt":[[305,662],[1128,662],[1128,711],[305,711]],"region":{"top_left_x":305,"top_left_y":661,"width":823,"height":51},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bdb8b6f74564407289fe4ebbf6aad64a","type":"text","conversion_output":true,"text":"evaluated at 30 days after the implant procedure.","text_display":" evaluated at 30 days after the implant procedure.","confidence":1,"confidence_rate":1},{"cnt":[[305,748],[1381,748],[1381,806],[305,806]],"region":{"top_left_x":305,"top_left_y":747,"width":1077,"height":59},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f62668e5e5f743c6ba145328959f4170","type":"section_header","conversion_output":false,"children_ids":["7f98d52bbd5b4a2389931bce3dc717be"],"text":"","text_display":""},{"cnt":[[309,752],[1377,752],[1377,801],[309,801]],"region":{"top_left_x":309,"top_left_y":751,"width":1069,"height":51},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7f98d52bbd5b4a2389931bce3dc717be","type":"text","conversion_output":true,"parent_id":"f62668e5e5f743c6ba145328959f4170","text":"12.1.1.1. Statistical Hypothesis for the Primary Safety Endpoint","text_display":"\n\n\\subsection*{12.1.1.1. Statistical Hypothesis for the Primary Safety Endpoint}","confidence":1,"confidence_rate":1},{"cnt":[[307,821],[1807,821],[1807,870],[307,870]],"region":{"top_left_x":307,"top_left_y":820,"width":1500,"height":51},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d338e5bf57414f49804422718b9aa562","type":"text","conversion_output":true,"text":"The statistical hypothesis is that the rate of the primary safety endpoint (composite of all-","text_display":"\n\nThe statistical hypothesis is that the rate of the primary safety endpoint (composite of all","confidence":1,"confidence_rate":1},{"cnt":[[305,868],[1861,868],[1861,917],[305,917]],"region":{"top_left_x":305,"top_left_y":867,"width":1556,"height":51},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"21ab87c0337f44c79d6b602ed20a7559","type":"text","conversion_output":true,"text":"cause mortality, stroke, life-threatening and major bleeding events, stage 2 or 3 acute kidney","text_display":"cause mortality, stroke, life-threatening and major bleeding events, stage 2 or 3 acute kidney","confidence":1,"confidence_rate":1},{"cnt":[[305,915],[1869,915],[1869,967],[305,967]],"region":{"top_left_x":305,"top_left_y":915,"width":1565,"height":52},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"02b1ff5ff31648dc88fdf7d639c7b5a2","type":"text","conversion_output":true,"text":"injury, or major vascular complications at 30 days) for the Lotus Valve is non-inferior to that","text_display":" injury, or major vascular complications at 30 days) for the Lotus Valve is non-inferior to that","confidence":0.8837890625,"confidence_rate":0.9988013319683924},{"cnt":[[305,965],[565,965],[565,1008],[305,1008]],"region":{"top_left_x":305,"top_left_y":964,"width":261,"height":44},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d5cefe805c424551b105958ba3c878ad","type":"text","conversion_output":true,"text":"for CoreValve.","text_display":" for CoreValve.","confidence":1,"confidence_rate":1},{"cnt":[[305,1033],[1760,1033],[1760,1085],[305,1085]],"region":{"top_left_x":305,"top_left_y":1033,"width":1455,"height":52},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b937b440bd4540d39ee130de8e706afd","type":"text","conversion_output":true,"text":"The primary safety endpoint is expressed as the proportion of subjects who experience","text_display":"\n\nThe primary safety endpoint is expressed as the proportion of subjects who experience","confidence":1,"confidence_rate":1},{"cnt":[[305,1079],[1876,1079],[1876,1132],[305,1132]],"region":{"top_left_x":305,"top_left_y":1078,"width":1571,"height":55},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cd2da21e0b684d73bd92926ce4dd807d","type":"text","conversion_output":true,"text":"mortality, stroke, life-threatening and major bleeding events, stage 2 or 3 acute kidney injury,","text_display":" mortality, stroke, life-threatening and major bleeding events, stage 2 or 3 acute kidney injury,","confidence":1,"confidence_rate":1},{"cnt":[[305,1130],[1858,1130],[1858,1179],[305,1179]],"region":{"top_left_x":305,"top_left_y":1130,"width":1554,"height":50},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bead0062f527409bbe4182bb10cbc6d6","type":"text","conversion_output":true,"text":"or major vascular complications within 30 days after the index procedure among all subjects","text_display":" or major vascular complications within 30 days after the index procedure among all subjects","confidence":0.99951171875,"confidence_rate":0.9999950666738041},{"cnt":[[305,1177],[1858,1177],[1858,1227],[305,1227]],"region":{"top_left_x":305,"top_left_y":1177,"width":1554,"height":50},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6d53556408fc4881b4a53ac4ed002c94","type":"text","conversion_output":true,"text":"who either experience mortality/stroke/life-threatening or major bleeding events/stage 2 or 3","text_display":" who either experience mortality/stroke/life-threatening or major bleeding events/stage 2 or 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after the index procedure.","confidence":1,"confidence_rate":1},{"cnt":[[305,1341],[1691,1341],[1691,1394],[305,1394]],"region":{"top_left_x":305,"top_left_y":1340,"width":1386,"height":55},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8ebc596633df420e9f08ee5cec0802b2","type":"text","conversion_output":true,"text":"The null and alternative hypotheses for the primary safety endpoint are as follows:","text_display":"\nThe null and alternative hypotheses for the primary safety endpoint are as follows:","confidence":1,"confidence_rate":1},{"cnt":[[425,1405],[1207,1405],[1207,1536],[425,1536]],"region":{"top_left_x":425,"top_left_y":1405,"width":783,"height":132},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"aa7977f95e7d4cccb18c56d471800eeb","type":"math","conversion_output":true,"text":"\\[\n\\begin{aligned}\n& H_{0}: P_{S \\_ \\text {Lotus }} \\text { minus } P_{S \\_ \\text {Control }} \\geq \\Delta \\text { (Inferior) } \\\\\n& H_{1}: P_{S \\_ \\text {Lotus }} \\text { minus } P_{S \\_ \\text {Control }}<\\Delta \\text { (Non-inferior) }\n\\end{aligned}\n\\]","text_display":"\n\\[\n\\begin{aligned}\n& H_{0}: P_{S \\_ \\text {Lotus }} \\text { minus } P_{S \\_ \\text {Control }} \\geq \\Delta \\text { (Inferior) } \\\\\n& H_{1}: P_{S \\_ \\text {Lotus }} \\text { minus } P_{S \\_ \\text {Control }}<\\Delta \\text { (Non-inferior) }\n\\end{aligned}\n\\]","confidence":0.11055678564534177,"confidence_rate":0.9891571037376721},{"cnt":[[305,1549],[1790,1549],[1790,1601],[305,1601]],"region":{"top_left_x":305,"top_left_y":1549,"width":1485,"height":52},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ca1095b0bdfb484f971f75b91e5e98eb","type":"text","conversion_output":true,"text":"where \\(P _{\\text {S_Lotus }}\\) and \\(P _{\\text {S_Control }}\\) are the rates of the primary safety endpoint at 30 days for the","text_display":"\nwhere \\(P _{\\text {S_Lotus }}\\) and \\(P _{\\text {S_Control }}\\) are the rates of the primary safety endpoint at 30 days for the","confidence":0.9892628192901611,"confidence_rate":0.9999212057306687},{"cnt":[[305,1594],[1871,1594],[1871,1648],[305,1648]],"region":{"top_left_x":305,"top_left_y":1594,"width":1567,"height":54},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c89eec6dd1334d389b7dd098692170d9","type":"text","conversion_output":true,"text":"Lotus Valve (test) group and the CoreValve group (control), respectively, and \\(\\Delta\\) (delta) is the","text_display":" Lotus Valve (test) group and the CoreValve group (control), respectively, and \\(\\Delta\\) (delta) is 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of","confidence":1,"confidence_rate":1},{"cnt":[[309,1762],[1876,1762],[1876,1811],[309,1811]],"region":{"top_left_x":309,"top_left_y":1761,"width":1567,"height":51},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"27cfcab504d94369bf20fb73861ac603","type":"text","conversion_output":true,"text":"noninferiority in the difference between the rates of the two treatment groups, as described in","text_display":" noninferiority in the difference between the rates of the two treatment groups, as described in","confidence":1,"confidence_rate":1},{"cnt":[[309,1809],[1865,1809],[1865,1858],[309,1858]],"region":{"top_left_x":309,"top_left_y":1808,"width":1556,"height":51},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8f5a8949487b4ed380e7970dc0cf3260","type":"text","conversion_output":true,"text":"the Statistical Analysis Plan. If the \\(P\\) value from the Farrington-Manning standardized test is","text_display":" the Statistical Analysis Plan. If the \\(P\\) value from the Farrington-Manning standardized test is","confidence":0.9985356330871582,"confidence_rate":0.9999856330429514},{"cnt":[[309,1856],[1833,1856],[1833,1906],[309,1906]],"region":{"top_left_x":309,"top_left_y":1856,"width":1524,"height":50},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b4b40aeef9164fcea251913c183c1c11","type":"text","conversion_output":true,"text":"\\(<0.025\\), the rate of the primary safety endpoint for the Lotus Valve will be concluded to be","text_display":" \\(<0.025\\), the rate of the primary safety endpoint for the Lotus Valve will be concluded to be","confidence":1,"confidence_rate":1},{"cnt":[[309,1904],[1695,1904],[1695,1955],[309,1955]],"region":{"top_left_x":309,"top_left_y":1903,"width":1387,"height":53},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"762c6ebec60e42448c4a4ae4afc097cd","type":"text","conversion_output":true,"text":"non-inferior to the CoreValve rate. This corresponds to the one-sided upper 97.5\\%","text_display":" non-inferior to the CoreValve rate. This corresponds to the one-sided upper 97.5\\%","confidence":1,"confidence_rate":1},{"cnt":[[309,1951],[1695,1951],[1695,2000],[309,2000]],"region":{"top_left_x":309,"top_left_y":1950,"width":1387,"height":51},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ab42caff42ea4d93a6dfa0ce53158d19","type":"text","conversion_output":true,"text":"confidence bound on the difference between treatment groups (Lotus Valve minus","text_display":" confidence bound on the difference between treatment groups (Lotus Valve minus","confidence":1,"confidence_rate":1},{"cnt":[[309,1998],[1858,1998],[1858,2052],[309,2052]],"region":{"top_left_x":309,"top_left_y":1998,"width":1550,"height":54},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"05fdb624832f46ff8887a6777622d1b5","type":"text","conversion_output":true,"text":"CoreValve) for the observed rate of the primary safety endpoint at 1 year being less than the","text_display":" CoreValve) for the observed rate of the primary safety endpoint at 1 year being less than the","confidence":0.9482421875,"confidence_rate":0.9994739469559506},{"cnt":[[309,2047],[703,2047],[703,2099],[309,2099]],"region":{"top_left_x":309,"top_left_y":2047,"width":394,"height":53},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"87338645251a474c82336a15f164ef66","type":"text","conversion_output":true,"text":"non-inferiority margin.","text_display":" non-inferiority margin.","confidence":1,"confidence_rate":1},{"cnt":[[305,2136],[1420,2136],[1420,2194],[305,2194]],"region":{"top_left_x":305,"top_left_y":2135,"width":1116,"height":59},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2c5beb4b14c843658a8a1465a5449bd5","type":"section_header","conversion_output":false,"children_ids":["231815be9e5c4e3b9b4fcab1355e6378"],"text":"","text_display":""},{"cnt":[[312,2140],[1416,2140],[1416,2189],[312,2189]],"region":{"top_left_x":311,"top_left_y":2139,"width":1105,"height":51},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"231815be9e5c4e3b9b4fcab1355e6378","type":"text","conversion_output":true,"parent_id":"2c5beb4b14c843658a8a1465a5449bd5","text":"12.1.1.2. Sample Size Parameters for the Primary Safety Endpoint","text_display":"\n\n\\subsection*{12.1.1.2. Sample Size Parameters for the Primary Safety Endpoint}","confidence":1,"confidence_rate":1},{"cnt":[[305,2206],[1738,2206],[1738,2258],[305,2258]],"region":{"top_left_x":305,"top_left_y":2206,"width":1434,"height":53},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"16e51f2889094ef7946230c02f5b4bb2","type":"text","conversion_output":true,"text":"The sample size calculation for the primary safety endpoint is based on the following","text_display":"\n\nThe sample size calculation for the primary safety endpoint is based on the following","confidence":1,"confidence_rate":1},{"cnt":[[305,2256],[535,2256],[535,2305],[305,2305]],"region":{"top_left_x":305,"top_left_y":2255,"width":230,"height":51},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"73f74a3c250448938e9f7b486254ef62","type":"text","conversion_output":true,"text":"assumptions.","text_display":" assumptions.","confidence":1,"confidence_rate":1},{"cnt":[[339,2325],[1072,2325],[1072,2374],[339,2374]],"region":{"top_left_x":339,"top_left_y":2324,"width":734,"height":51},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2f365453713d4344a47d582987d7b0ff","type":"text","conversion_output":true,"text":"- Expected Lotus Valve (test) rate \\(=40 \\%\\)","text_display":"\n- Expected Lotus Valve (test) rate \\(=40 \\%\\)","confidence":1,"confidence_rate":1},{"cnt":[[339,2391],[1106,2391],[1106,2443],[339,2443]],"region":{"top_left_x":339,"top_left_y":2391,"width":768,"height":52},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f17c3c9eb58c4cdbacfdaf46782ad8a7","type":"text","conversion_output":true,"text":"- Expected CoreValve (control) rate \\(=40 \\%\\)","text_display":"\n- Expected CoreValve (control) rate \\(=40 \\%\\)","confidence":0.9912109375,"confidence_rate":0.9997993857138384},{"cnt":[[103,2651],[312,2651],[312,2692],[103,2692]],"region":{"top_left_x":103,"top_left_y":2651,"width":209,"height":41},"line":47,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d1ade2ef38c94776a5ace4e7d528cf03","type":"page_info","conversion_output":false,"text":"Released","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[829,2655],[1296,2655],[1296,2692],[829,2692]],"region":{"top_left_x":829,"top_left_y":2655,"width":467,"height":37},"line":48,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"477769d7ffda4f49a4cc79bcba3d3d6b","type":"page_info","conversion_output":false,"text":"REPRISE III Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1654,2653],[1983,2653],[1983,2692],[1654,2692]],"region":{"top_left_x":1654,"top_left_y":2653,"width":330,"height":39},"line":49,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"be35cadea84348a8b588797005312a50","type":"page_info","conversion_output":false,"text":"90899936 AK. 4","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[486,2690],[2004,2690],[2004,2735],[486,2735]],"region":{"top_left_x":485,"top_left_y":2689,"width":1520,"height":46},"line":50,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9471f52968ae448f9553b90a83fb80fd","type":"page_info","conversion_output":false,"text":"Boston Scientific Confidential. 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Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1482,223],[1880,223],[1880,264],[1482,264]],"region":{"top_left_x":1482,"top_left_y":223,"width":398,"height":42},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6b8ce1a41d9e4f15914508f5fc29c93a","type":"page_info","conversion_output":false,"text":"90899936 Rev/Ver AK","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999787654211912},{"cnt":[[1620,271],[1880,271],[1880,320],[1620,320]],"region":{"top_left_x":1619,"top_left_y":270,"width":261,"height":51},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3eb9a3003f0d47d68ef13c88b41bdce7","type":"page_info","conversion_output":false,"text":"Page 81 of 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the given expected rates.","text_display":" is approximately \\(85 \\%\\) power to show non-inferiority with the given expected rates.","confidence":1,"confidence_rate":1},{"cnt":[[305,752],[1248,752],[1248,810],[305,810]],"region":{"top_left_x":305,"top_left_y":751,"width":944,"height":59},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"156382dbc21745798eaf1fc88ad74819","type":"section_header","conversion_output":false,"children_ids":["4f9d8f7119bc4ffaa67c997b0dd217f5"],"text":"","text_display":""},{"cnt":[[312,756],[1244,756],[1244,806],[312,806]],"region":{"top_left_x":311,"top_left_y":756,"width":933,"height":50},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4f9d8f7119bc4ffaa67c997b0dd217f5","type":"text","conversion_output":true,"parent_id":"156382dbc21745798eaf1fc88ad74819","text":"12.1.1.3. 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Any events or","confidence":1,"confidence_rate":1},{"cnt":[[305,872],[1869,872],[1869,922],[305,922]],"region":{"top_left_x":305,"top_left_y":872,"width":1565,"height":50},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"560bb94311734b659dee6bde22ac04fe","type":"text","conversion_output":true,"text":"hospitalizations occurring after enrollment but prior to the index procedure should be entered","text_display":" hospitalizations occurring after enrollment but prior to the index procedure should be entered","confidence":1,"confidence_rate":1},{"cnt":[[307,920],[1794,920],[1794,969],[307,969]],"region":{"top_left_x":307,"top_left_y":919,"width":1487,"height":50},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"979a3b67f17147818883400d86100acb","type":"text","conversion_output":true,"text":"in the electronic data capture system; events with onset date starting from the time of the","text_display":" in the electronic data capture system; events with onset date starting from the time of the","confidence":1,"confidence_rate":1},{"cnt":[[305,967],[1420,967],[1420,1016],[305,1016]],"region":{"top_left_x":305,"top_left_y":966,"width":1116,"height":51},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3c781b3465e041bb80b31737836cdc40","type":"text","conversion_output":true,"text":"index procedure will be included in the primary endpoint analysis.","text_display":" index procedure will be included in the primary endpoint analysis.","confidence":1,"confidence_rate":1},{"cnt":[[305,1036],[1837,1036],[1837,1085],[305,1085]],"region":{"top_left_x":305,"top_left_y":1035,"width":1532,"height":50},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7ae1703acdae4f1790f68891d049f550","type":"text","conversion_output":true,"text":"Handling of dropouts and missing data will depend on their frequency and the nature of the","text_display":"\n\nHandling of dropouts and missing data will depend on their frequency and the nature of the","confidence":1,"confidence_rate":1},{"cnt":[[307,1085],[1792,1085],[1792,1132],[307,1132]],"region":{"top_left_x":307,"top_left_y":1084,"width":1485,"height":49},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"59a1e9a94424496aa73e24a5a105e3c9","type":"text","conversion_output":true,"text":"outcome measure. Sensitivity analyses (e.g., tipping-point analysis) will be performed to","text_display":" outcome measure. 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less than that of the CoreValve group.","text_display":" effectiveness endpoint for the Lotus group is less than that of the CoreValve group.","confidence":0.9521715641021729,"confidence_rate":0.9994494769189273},{"cnt":[[305,1354],[1876,1354],[1876,1403],[305,1403]],"region":{"top_left_x":305,"top_left_y":1353,"width":1571,"height":50},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a08378f8647a4056a75d6a9fe9e64144","type":"text","conversion_output":true,"text":"The null and alternative hypotheses for the secondary hypothesis of the primary effectiveness","text_display":"\n\nThe null and alternative hypotheses for the secondary hypothesis of the primary 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be used to test the two-sided hypothesis of superiority between the","confidence":1,"confidence_rate":1},{"cnt":[[305,1772],[1858,1772],[1858,1824],[305,1824]],"region":{"top_left_x":305,"top_left_y":1772,"width":1554,"height":53},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d5fee660cd9f40c78a752b2f0c40c8a2","type":"text","conversion_output":true,"text":"rates of the two treatment groups, as described in the Statistical Analysis Plan. 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188","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[425,335],[857,335],[857,466],[425,466]],"region":{"top_left_x":425,"top_left_y":335,"width":433,"height":132},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"38294883064741f7b1ab8256a378da34","type":"math","conversion_output":true,"text":"\\[\n\\begin{aligned}\n& H_{0}: P_{\\text {AR_Lotus }}=P_{\\text {AR_Control }} \\\\\n& H_{1}: P_{\\text {AR_Lotus }} \\neq P_{\\text {AR_Control }}\n\\end{aligned}\n\\]","text_display":"\n\\[\n\\begin{aligned}\n& H_{0}: P_{\\text {AR_Lotus }}=P_{\\text {AR_Control }} \\\\\n& H_{1}: P_{\\text {AR_Lotus }} \\neq P_{\\text {AR_Control 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If the \\(P\\) value","text_display":" rates of the two treatment groups, as described in the Statistical Analysis Plan. If the \\(P\\) value","confidence":0.9975600242614746,"confidence_rate":0.9999765103015572},{"cnt":[[305,737],[1867,737],[1867,784],[305,784]],"region":{"top_left_x":305,"top_left_y":736,"width":1562,"height":49},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8f751183665b49da846880f757661187","type":"text","conversion_output":true,"text":"from the chi-square test is \\(<0.05\\) and the rate of the Lotus Valve group is less than the rate of","text_display":" from the chi-square test is \\(<0.05\\) and the rate of the Lotus Valve group is less than the rate of","confidence":0.9167776107788086,"confidence_rate":0.9991648647430657},{"cnt":[[307,786],[1863,786],[1863,834],[307,834]],"region":{"top_left_x":307,"top_left_y":786,"width":1556,"height":48},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2cac5444e01d4374b1416d3859faa9f1","type":"text","conversion_output":true,"text":"the CoreValve group, the rate of moderate or greater paravalvular aortic regurgitation for the","text_display":" the CoreValve group, the rate of moderate or greater paravalvular aortic regurgitation for the","confidence":1,"confidence_rate":1},{"cnt":[[305,834],[1704,834],[1704,883],[305,883]],"region":{"top_left_x":305,"top_left_y":833,"width":1399,"height":51},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9219ece0a57e47da9e83a820cdbeb680","type":"text","conversion_output":true,"text":"Lotus Valve group will be concluded to be superior to that of the CoreValve group.","text_display":" Lotus Valve group will be concluded to be superior to that of the CoreValve group.","confidence":0.99951171875,"confidence_rate":0.9999943862169285},{"cnt":[[305,920],[1347,920],[1347,975],[305,975]],"region":{"top_left_x":305,"top_left_y":919,"width":1043,"height":57},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"34bd7c5b66b54acc80f5083a921547e8","type":"section_header","conversion_output":false,"children_ids":["6caf69ef1aa946d792d1ad99d425d929"],"text":"","text_display":""},{"cnt":[[309,924],[1343,924],[1343,973],[309,973]],"region":{"top_left_x":309,"top_left_y":923,"width":1034,"height":51},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6caf69ef1aa946d792d1ad99d425d929","type":"text","conversion_output":true,"parent_id":"34bd7c5b66b54acc80f5083a921547e8","text":"12.1.3.2. Sample Size Parameters for the Secondary Endpoint","text_display":"\n\n\\subsection*{12.1.3.2. Sample Size Parameters for the Secondary Endpoint}","confidence":0.99755859375,"confidence_rate":0.9999618071146515},{"cnt":[[307,993],[1854,993],[1854,1042],[307,1042]],"region":{"top_left_x":307,"top_left_y":992,"width":1548,"height":50},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"49f9ae60ab4b48a0acf0de38ed8585a9","type":"text","conversion_output":true,"text":"The sample size calculation for the secondary endpoint (moderate/severe paravalvular aortic","text_display":"\n\nThe sample size calculation for the secondary endpoint (moderate/severe paravalvular aortic","confidence":0.99658203125,"confidence_rate":0.9999643358094245},{"cnt":[[305,1040],[1429,1040],[1429,1089],[305,1089]],"region":{"top_left_x":305,"top_left_y":1039,"width":1124,"height":51},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"eccb7d8b5425417494820362626ea8ac","type":"text","conversion_output":true,"text":"regurgitation rate at 1 year) is based on the following assumptions.","text_display":" regurgitation rate at 1 year) is based on the following assumptions.","confidence":0.99951171875,"confidence_rate":0.9999935736983052},{"cnt":[[339,1109],[1240,1109],[1240,1160],[339,1160]],"region":{"top_left_x":339,"top_left_y":1108,"width":901,"height":53},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ac4bc86573bf49a6921ebed322de49c4","type":"text","conversion_output":true,"text":"- Expected Lotus Valve (test) rate \\(P _{\\text {AR_Lotus }}=1.1 \\%\\)","text_display":"\n- Expected Lotus Valve (test) rate \\(P _{\\text {AR_Lotus }}=1.1 \\%\\)","confidence":0.9931640625,"confidence_rate":0.9998991314177115},{"cnt":[[339,1177],[1296,1177],[1296,1227],[339,1227]],"region":{"top_left_x":339,"top_left_y":1177,"width":957,"height":50},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1933a90839624286b46a785716db847e","type":"text","conversion_output":true,"text":"- Expected CoreValve (control) rate \\(P _{\\text {AR_Control }}=5.3 \\%\\)","text_display":"\n- Expected CoreValve (control) rate \\(P _{\\text {AR_Control }}=5.3 \\%\\)","confidence":0.9873046875,"confidence_rate":0.9998200642667286},{"cnt":[[339,1250],[1128,1250],[1128,1300],[339,1300]],"region":{"top_left_x":339,"top_left_y":1250,"width":789,"height":50},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2b50ae3e57464f45b0921b59e3cf9d39","type":"text","conversion_output":true,"text":"- Test significance level \\((\\alpha)=0.05\\) ( 2 -sided)","text_display":"\n- Test significance level \\((\\alpha)=0.05\\) ( 2 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rates.","text_display":" is approximately \\(86 \\%\\) power to show superiority with the given expected rates.","confidence":1,"confidence_rate":1},{"cnt":[[305,1590],[1175,1590],[1175,1646],[305,1646]],"region":{"top_left_x":305,"top_left_y":1589,"width":871,"height":57},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"80036de79ea84abeaea3a000b8723369","type":"section_header","conversion_output":false,"children_ids":["63dbfd6fe9e64cec8a9d475fd53df04f"],"text":"","text_display":""},{"cnt":[[309,1594],[1171,1594],[1171,1644],[309,1644]],"region":{"top_left_x":309,"top_left_y":1594,"width":862,"height":50},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"63dbfd6fe9e64cec8a9d475fd53df04f","type":"text","conversion_output":true,"parent_id":"80036de79ea84abeaea3a000b8723369","text":"12.1.3.3. Statistical Methods - Secondary Endpoint","text_display":"\n\n\\subsection*{12.1.3.3. 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Treatments for the randomized subjects will be compared with a chi-","text_display":" discrete variables. 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The IRB/EC will determine the subject population to be","text_display":" requested by the center's IRB/EC. 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Safety Reporting","text_display":"\n\n\\section*{21. Safety Reporting}","confidence":0.99951171875,"confidence_rate":0.9999804641709025},{"cnt":[[305,715],[958,715],[958,771],[305,771]],"region":{"top_left_x":305,"top_left_y":715,"width":654,"height":57},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"805bcebd68974e42ae14c608b46647b3","type":"section_header","conversion_output":false,"children_ids":["e337b389a9044a24bfd52d766c63f467"],"text":"","text_display":""},{"cnt":[[309,718],[956,718],[956,767],[309,767]],"region":{"top_left_x":309,"top_left_y":717,"width":648,"height":50},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e337b389a9044a24bfd52d766c63f467","type":"text","conversion_output":true,"parent_id":"805bcebd68974e42ae14c608b46647b3","text":"21.1. Definitions and Classification","text_display":"\n\n\\subsection*{21.1. Definitions and Classification}","confidence":0.9785635198932141,"confidence_rate":0.9994716133362854},{"cnt":[[309,808],[1240,808],[1240,857],[309,857]],"region":{"top_left_x":309,"top_left_y":807,"width":931,"height":51},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"66e5d0fd1b3348afadb4b62ecd5a8bd1","type":"text","conversion_output":true,"text":"Adverse event definitions are provided in Table 21.1-1.","text_display":"\n\nAdverse event definitions are provided in Table 21.1-1.","confidence":1,"confidence_rate":1},{"cnt":[[752,885],[1472,885],[1472,930],[752,930]],"region":{"top_left_x":751,"top_left_y":885,"width":721,"height":46},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cf71b631524a47a4bcad911c0aee038d","type":"figure_label","conversion_output":false,"text":"Table 21.1-1: Adverse Event Definitions","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[309,941],[1921,941],[1921,2499],[309,2499]],"region":{"top_left_x":309,"top_left_y":941,"width":1612,"height":1558},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e50b0a6c503a4b76838e5c3847ffd4da","type":"table","conversion_output":true,"children_ids":["c14c5aec21da4e8b801a30e3b9f885d8","58177583e00a4342911c0f8956e10b8c","d73bd784ab624f6a93d5f6ecd49e5563","38a4342d9cc2405da2d45c1ba7cb73fb","a4f260f4f45e481d959587bc4cf43fd5","6b238746ffd444bf8f32eaf5e49659a0","70053f028d60438fa8c1b9c33ad9a5b4","8c64190e397243b49e322be3a3b51fdf","be81287f9c00407f9c72ff1449059e21","6ac80e77030245b38e6fa0ff2993b077","8584bf923ca04fd0868eddcc087963d1","40f4e86bcfe340008b42a04b042f5422","54d5f08f1bf84af9bd48114cf9806b91","99f2d3af77864e6787e7e12ec20c1814","bf5a287aa35744aaa090a2fc55eec2df","89aa06914e0444d2857f1f231cccb86d","fd4f111c4ad7458cb2cf937cf5ceda51"],"selected_labels":["cf71b631524a47a4bcad911c0aee038d"],"text":"\\begin{tabular}{|l|l|}\n\\hline Term & Definition \\({ }^{\\text {a }}\\) \\\\\n\\hline \\begin{tabular}{l}\nAdverse Event (AE) \\\\\nRef: ISO 14155:2011\n\\end{tabular} & \\begin{tabular}{l}\nAny untoward medical occurrence, unintended disease or injury or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device \\\\\nNote 1: This definition includes events related to the investigational medical device or the comparator. \\\\\nNote 2: This definition includes events related to the procedures involved. \\\\\nNote 3: For users or other persons, this definition is restricted to events related to investigational medical devices.\n\\end{tabular} \\\\\n\\hline Adverse Device Effect (ADE) Ref: ISO 14155:2011 & \\begin{tabular}{l}\nAdverse event related to the use of an investigational medical device \\\\\nNote 1: This definition includes adverse events resulting from insufficient or inadequate instructions for use, deployment, implantation, installation, or operation, or any malfunction of the investigational medical device. \\\\\nNote 2: This definition includes any event resulting from use error or from intentional misuse of the investigational medical device.\n\\end{tabular} \\\\\n\\hline Serious Adverse Event (SAE) Ref: ISO 14155:2011 & \\begin{tabular}{l}\nAdverse event that: \\\\\n- Led to a death \\\\\n- Led to serious deterioration in the health of the subject, that either resulted in: \\\\\n- a life-threatening illness or injury, or \\\\\n- a permanent impairment of a body structure or a body function, or \\\\\n- in-patient or prolonged hospitalization, or \\\\\n- medical or surgical intervention to prevent life- threatening illness or injury or permanent impairment to a body structure or a body function, \\\\\n- Led to fetal distress, fetal death or a congenital abnormality or birth defect \\\\\nNote: Planned hospitalization for a pre-existing condition, or a procedure required by the protocol, without serious deterioration in health, is not considered a serious adverse event.\n\\end{tabular} \\\\\n\\hline \\begin{tabular}{l}\nSerious Adverse Device Effect (SADE) \\\\\nRef: ISO 14155:2011\n\\end{tabular} & Adverse device effect that has resulted in any of the consequences characteristic of a serious adverse event. \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Table 21.1-1: Adverse Event Definitions}\n\\begin{tabular}{|l|l|}\n\\hline Term & Definition \\({ }^{\\text {a }}\\) \\\\\n\\hline \\begin{tabular}{l}\nAdverse Event (AE) \\\\\nRef: ISO 14155:2011\n\\end{tabular} & \\begin{tabular}{l}\nAny untoward medical occurrence, unintended disease or injury or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device \\\\\nNote 1: This definition includes events related to the investigational medical device or the comparator. \\\\\nNote 2: This definition includes events related to the procedures involved. \\\\\nNote 3: For users or other persons, this definition is restricted to events related to investigational medical devices.\n\\end{tabular} \\\\\n\\hline Adverse Device Effect (ADE) Ref: ISO 14155:2011 & \\begin{tabular}{l}\nAdverse event related to the use of an investigational medical device \\\\\nNote 1: This definition includes adverse events resulting from insufficient or inadequate instructions for use, deployment, implantation, installation, or operation, or any malfunction of the investigational medical device. \\\\\nNote 2: This definition includes any event resulting from use error or from intentional misuse of the investigational medical device.\n\\end{tabular} \\\\\n\\hline Serious Adverse Event (SAE) Ref: ISO 14155:2011 & \\begin{tabular}{l}\nAdverse event that: \\\\\n- Led to a death \\\\\n- Led to serious deterioration in the health of the subject, that either resulted in: \\\\\n- a life-threatening illness or injury, or \\\\\n- a permanent impairment of a body structure or a body function, or \\\\\n- in-patient or prolonged hospitalization, or \\\\\n- medical or surgical intervention to prevent life- threatening illness or injury or permanent impairment to a body structure or a body function, \\\\\n- Led to fetal distress, fetal death or a congenital abnormality or birth defect \\\\\nNote: Planned hospitalization for a pre-existing condition, or a procedure required by the protocol, without serious deterioration in health, is not considered a serious adverse event.\n\\end{tabular} \\\\\n\\hline \\begin{tabular}{l}\nSerious Adverse Device Effect (SADE) \\\\\nRef: ISO 14155:2011\n\\end{tabular} & Adverse device effect that has resulted in any of the consequences characteristic of a serious adverse event. 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serious adverse event.","text_display":"Adverse device effect that has resulted in any of the consequences characteristic of a serious adverse event.","cell_row":4,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[842,2370],[1766,2370],[1766,2409],[842,2409]],"region":{"top_left_x":841,"top_left_y":2370,"width":926,"height":40},"line":75,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"00ddb44f1e0d4cf7903de5136b1114f1","type":"text","conversion_output":false,"parent_id":"fd4f111c4ad7458cb2cf937cf5ceda51","text":"Adverse device effect that has resulted in any of the consequences","text_display":"Adverse device effect that has resulted in any of the 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Definitions","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[305,402],[1921,402],[1921,1347],[305,1347]],"region":{"top_left_x":305,"top_left_y":401,"width":1616,"height":947},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"38fd635e0d6a401293b7e4f97525364f","type":"table","conversion_output":true,"children_ids":["945bd232630b44ee91e07a5d287793ee","728f3824669c4af681d0a750181fa33b","779b6e2995594ebaa07fd3781a17892b","f9bd5b90aa8e4baf8a80596eedb27d08","9dac1ef225304b2e95aa9b0aa2e76545","c81b8d084cf846f3a6e0c1619fdcb61f","4c5eac4f836c4e78aa988c2da5e83b65","e3a158203613489e9c5e2577cf66c63b","893e896c40bd43f491430794dcb526ce","7734df021d5340fd8eabe1fd095614b5","82a566e3f40f4711958580c264f830a7","c48bda56ae53462bb16b019010ee4cfb","d206bb7e6cec4a939d5172a387dad645","e1cc56e10b0648618b4fdcd2d40c103c"],"selected_labels":["58f68d6011394621ba778b9e81403f61"],"text":"\\begin{tabular}{|l|l|}\n\\hline Term & Definition \\({ }^{\\text {a }}\\) \\\\\n\\hline \\begin{tabular}{l}\nUnanticipated Adverse Device Effect (UADE) \\\\\nRef: 21 CFR Part 812\n\\end{tabular} & Any serious adverse effect on health or safety or any life-threatening problem or death caused by, or associated with, a device, if that effect, problem, or death was not previously identified in nature, severity, or degree of incidence in the investigational plan or application (including a supplementary plan or application), or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects. \\\\\n\\hline Unanticipated Serious Adverse Device Effect (USADE) Ref: ISO 14155:2011 & \\begin{tabular}{l}\nSerious adverse device effect which by its nature, incidence, severity or outcome has not been identified in the current version of the risk analysis report \\\\\nNote: Anticipated serious adverse device effect (ASADE) is an effect which by its nature, incidence, severity or outcome has been identified in the 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Event","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[288,404],[1897,404],[1897,862],[288,862]],"region":{"top_left_x":287,"top_left_y":403,"width":1611,"height":459},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1624d09c60c34f9ea10fd4b544f8b7d4","type":"table","conversion_output":true,"children_ids":["980a2d4b625342c8ac79be74861e803d","b59fb96039ec4a83a242591b67fb4a6b","aa9414d7d66e404b9ce3f590435da1c6","5f7c31b754b640f994dfbc7d5b2b79bf","5cafa2eb103c49d6af7be2d26c4fd9b6","3b73af86c6614903b64fa1e84b4411ef","ec08857252f64594948c9b311b6bac75","4c5b0c219f8747fb88aab63a38dc7228","10b9f2f7e6da410793f9c1c698a37a26","fbc277035d7b4c4494c5dec1523e5dfa","f7db6939fc6c443a9f323340db784fe0"],"selected_labels":["63a3898247fc4395a57b4d98e3791315"],"text":"\\begin{tabular}{|l|l|}\n\\hline Classification & Description \\\\\n\\hline Unrelated & The adverse event is determined to be due to a concurrent illness or effect of another device/drug and is not related to the investigational product. \\\\\n\\hline Related & \\begin{tabular}{l}\n- The adverse event is determined to be potentially related to the investigational product, and an alternative etiology is equally or less likely compared to the potential relationship to investigational product. \\\\\n- There is a strong relationship to investigational product, or recurs on re-challenge, and another etiology is unlikely. \\\\\n- There is no other reasonable medical explanation for the event.\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Table 21.2-1: Criteria for Assessing Relationship of Study Device to Adverse Event}\n\\begin{tabular}{|l|l|}\n\\hline Classification & Description \\\\\n\\hline Unrelated & The adverse event is determined to be due to a concurrent illness or effect of another device/drug and is not related to the investigational product. \\\\\n\\hline Related & \\begin{tabular}{l}\n- The adverse event is determined to be potentially related to the investigational product, and an alternative etiology is equally or less likely compared to the potential relationship to investigational product. \\\\\n- There is a strong relationship to investigational product, or recurs on re-challenge, and another etiology is unlikely. \\\\\n- There is no other reasonable medical explanation for the event.\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}\n\\end{table}","confidence":0.99951171875,"confidence_rate":0.9999998061902973},{"cnt":[[306,403],[519,403],[519,862],[306,862]],"region":{"top_left_x":306,"top_left_y":403,"width":213,"height":460},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"980a2d4b625342c8ac79be74861e803d","type":"table_column","conversion_output":false,"parent_id":"1624d09c60c34f9ea10fd4b544f8b7d4","text":"","text_display":""},{"cnt":[[664,403],[1868,403],[1868,862],[664,862]],"region":{"top_left_x":663,"top_left_y":403,"width":1205,"height":460},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b59fb96039ec4a83a242591b67fb4a6b","type":"table_column","conversion_output":false,"parent_id":"1624d09c60c34f9ea10fd4b544f8b7d4","text":"","text_display":""},{"cnt":[[287,416],[1898,416],[1898,466],[287,466]],"region":{"top_left_x":287,"top_left_y":415,"width":1612,"height":51},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"aa9414d7d66e404b9ce3f590435da1c6","type":"table_row","conversion_output":false,"parent_id":"1624d09c60c34f9ea10fd4b544f8b7d4","text":"","text_display":""},{"cnt":[[287,477],[1898,477],[1898,570],[287,570]],"region":{"top_left_x":287,"top_left_y":476,"width":1612,"height":94},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5f7c31b754b640f994dfbc7d5b2b79bf","type":"table_row","conversion_output":false,"parent_id":"1624d09c60c34f9ea10fd4b544f8b7d4","text":"","text_display":""},{"cnt":[[287,568],[1898,568],[1898,849],[287,849]],"region":{"top_left_x":287,"top_left_y":567,"width":1612,"height":283},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5cafa2eb103c49d6af7be2d26c4fd9b6","type":"table_row","conversion_output":false,"parent_id":"1624d09c60c34f9ea10fd4b544f8b7d4","text":"","text_display":""},{"cnt":[[309,420],[514,420],[514,457],[309,457]],"region":{"top_left_x":308,"top_left_y":420,"width":207,"height":38},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3b73af86c6614903b64fa1e84b4411ef","type":"simple_cell","conversion_output":false,"parent_id":"1624d09c60c34f9ea10fd4b544f8b7d4","text":"Classification","text_display":"Classification","cell_row":0,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[672,420],[852,420],[852,461],[672,461]],"region":{"top_left_x":672,"top_left_y":420,"width":181,"height":42},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ec08857252f64594948c9b311b6bac75","type":"simple_cell","conversion_output":false,"parent_id":"1624d09c60c34f9ea10fd4b544f8b7d4","text":"Description","text_display":"Description","cell_row":0,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[309,483],[465,483],[465,518],[309,518]],"region":{"top_left_x":308,"top_left_y":483,"width":157,"height":35},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4c5b0c219f8747fb88aab63a38dc7228","type":"simple_cell","conversion_output":false,"parent_id":"1624d09c60c34f9ea10fd4b544f8b7d4","text":"Unrelated","text_display":"Unrelated","cell_row":1,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[670,481],[1859,481],[1859,565],[670,565]],"region":{"top_left_x":670,"top_left_y":480,"width":1190,"height":86},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"10b9f2f7e6da410793f9c1c698a37a26","type":"complex_cell","conversion_output":false,"parent_id":"1624d09c60c34f9ea10fd4b544f8b7d4","children_ids":["3a5427ba2ce04a76bd3c2a87518d302a","4d453327bf9a4410af7334b3b67bb962"],"text":"The adverse event is determined to be due to a concurrent illness or effect of another device/drug and is not related to the investigational product.","text_display":"The adverse event is determined to be due to a concurrent illness or effect of another device/drug and is not related to the investigational product.","cell_row":1,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[672,483],[1857,483],[1857,518],[672,518]],"region":{"top_left_x":672,"top_left_y":483,"width":1185,"height":35},"line":20,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3a5427ba2ce04a76bd3c2a87518d302a","type":"text","conversion_output":false,"parent_id":"10b9f2f7e6da410793f9c1c698a37a26","text":"The adverse event is determined to be due to a concurrent illness or effect of another","text_display":"The adverse event is determined to be due to a concurrent illness or effect of another","confidence":1,"confidence_rate":1},{"cnt":[[672,524],[1511,524],[1511,565],[672,565]],"region":{"top_left_x":672,"top_left_y":524,"width":839,"height":42},"line":21,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4d453327bf9a4410af7334b3b67bb962","type":"text","conversion_output":false,"parent_id":"10b9f2f7e6da410793f9c1c698a37a26","text":"device/drug and is not related to the investigational product.","text_display":" device/drug and is not related to the investigational product.","confidence":1,"confidence_rate":1},{"cnt":[[309,572],[430,572],[430,607],[309,607]],"region":{"top_left_x":308,"top_left_y":571,"width":122,"height":36},"line":22,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"fbc277035d7b4c4494c5dec1523e5dfa","type":"simple_cell","conversion_output":false,"parent_id":"1624d09c60c34f9ea10fd4b544f8b7d4","text":"Related","text_display":"Related","cell_row":2,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[670,578],[1859,578],[1859,849],[670,849]],"region":{"top_left_x":670,"top_left_y":578,"width":1190,"height":272},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f7db6939fc6c443a9f323340db784fe0","type":"complex_cell","conversion_output":false,"parent_id":"1624d09c60c34f9ea10fd4b544f8b7d4","children_ids":["61aaaad716de425595b9e4c6c09e490d","63dc8adfd31d4f4ea9a138888a73bce3","01b3cd0283fe4d839c31284bf48b5664","d35f53966aa444c5925ff4bf118da359","14f64618dbf34666bbe7d9b9bc201de8","0a3d6eaf6f564b558373c7ef8fd758e8"],"text":"\\begin{tabular}{l}\n- The adverse event is determined to be potentially related to the investigational product, and an alternative etiology is equally or less likely compared to the potential relationship to investigational product. \\\\\n- There is a strong relationship to investigational product, or recurs on re-challenge, and another etiology is unlikely. \\\\\n- There is no other reasonable medical explanation for the event.\n\\end{tabular}","text_display":"\\begin{tabular}{l}\n- The adverse event is determined to be potentially related to the investigational product, and an alternative etiology is equally or less likely compared to the potential relationship to investigational product. \\\\\n- There is a strong relationship to investigational product, or recurs on re-challenge, and another etiology is unlikely. \\\\\n- There is no other reasonable medical explanation for the event.\n\\end{tabular}","cell_row":2,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.99951171875,"confidence_rate":0.9999988371423473},{"cnt":[[672,581],[1803,581],[1803,622],[672,622]],"region":{"top_left_x":672,"top_left_y":580,"width":1131,"height":42},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"61aaaad716de425595b9e4c6c09e490d","type":"text","conversion_output":false,"parent_id":"f7db6939fc6c443a9f323340db784fe0","text":"- The adverse event is determined to be potentially related to the investigational","text_display":"- The adverse event is determined to be potentially related to the investigational","confidence":1,"confidence_rate":1},{"cnt":[[707,622],[1770,622],[1770,665],[707,665]],"region":{"top_left_x":707,"top_left_y":621,"width":1064,"height":45},"line":25,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"63dc8adfd31d4f4ea9a138888a73bce3","type":"text","conversion_output":false,"parent_id":"f7db6939fc6c443a9f323340db784fe0","text":"product, and an alternative etiology is equally or less likely compared to the","text_display":" product, and an alternative etiology is equally or less likely compared to the","confidence":1,"confidence_rate":1},{"cnt":[[707,663],[1381,663],[1381,704],[707,704]],"region":{"top_left_x":707,"top_left_y":662,"width":674,"height":43},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"01b3cd0283fe4d839c31284bf48b5664","type":"text","conversion_output":false,"parent_id":"f7db6939fc6c443a9f323340db784fe0","text":"potential relationship to investigational product.","text_display":" potential relationship to investigational product.","confidence":1,"confidence_rate":1},{"cnt":[[672,715],[1857,715],[1857,756],[672,756]],"region":{"top_left_x":672,"top_left_y":714,"width":1185,"height":42},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d35f53966aa444c5925ff4bf118da359","type":"text","conversion_output":false,"parent_id":"f7db6939fc6c443a9f323340db784fe0","text":"- There is a strong relationship to investigational product, or recurs on re-challenge,","text_display":"\n- There is a strong relationship to investigational product, or recurs on re-challenge,","confidence":1,"confidence_rate":1},{"cnt":[[709,754],[1164,754],[1164,795],[709,795]],"region":{"top_left_x":709,"top_left_y":753,"width":456,"height":42},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"14f64618dbf34666bbe7d9b9bc201de8","type":"text","conversion_output":false,"parent_id":"f7db6939fc6c443a9f323340db784fe0","text":"and another etiology is unlikely.","text_display":" and another etiology is unlikely.","confidence":1,"confidence_rate":1},{"cnt":[[672,806],[1591,806],[1591,847],[672,847]],"region":{"top_left_x":672,"top_left_y":805,"width":919,"height":42},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0a3d6eaf6f564b558373c7ef8fd758e8","type":"text","conversion_output":false,"parent_id":"f7db6939fc6c443a9f323340db784fe0","text":"- There is no other reasonable medical explanation for the event.","text_display":"\n- There is no other reasonable medical explanation for the event.","confidence":0.99951171875,"confidence_rate":0.9999930228743673},{"cnt":[[305,945],[1081,945],[1081,1001],[305,1001]],"region":{"top_left_x":305,"top_left_y":945,"width":776,"height":57},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"205420c4d69848a698d69e9f32a18ce8","type":"section_header","conversion_output":false,"children_ids":["c1c0e1233cd0474f8dd569858aa7c563"],"text":"","text_display":""},{"cnt":[[309,950],[1076,950],[1076,999],[309,999]],"region":{"top_left_x":309,"top_left_y":949,"width":768,"height":51},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c1c0e1233cd0474f8dd569858aa7c563","type":"text","conversion_output":true,"parent_id":"205420c4d69848a698d69e9f32a18ce8","text":"21.3. Investigator Reporting Requirements","text_display":"\n\n\\subsection*{21.3. Investigator Reporting Requirements}","confidence":0.99951171875,"confidence_rate":0.9999893826542317},{"cnt":[[309,1040],[1732,1040],[1732,1087],[309,1087]],"region":{"top_left_x":309,"top_left_y":1039,"width":1423,"height":49},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"17777d11018f4694983dae412ca27a65","type":"text","conversion_output":true,"text":"The communication requirements for reporting to BSC are as shown in Table 21.3-1.","text_display":"\n\nThe communication requirements for reporting to BSC are as shown in Table 21.3-1.","confidence":0.9985356330871582,"confidence_rate":0.9999829601434831},{"cnt":[[305,1109],[1815,1109],[1815,1154],[305,1154]],"region":{"top_left_x":305,"top_left_y":1108,"width":1511,"height":46},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"518273611fbb48ac9be6d0114bfe2a07","type":"text","conversion_output":true,"text":"Note: The \"become aware date\" for an event that requires reporting per the protocol is the","text_display":"\nNote: The \"become aware date\" for an event that requires reporting per the protocol is the","confidence":0.99951171875,"confidence_rate":0.9999948589553403},{"cnt":[[305,1156],[1869,1156],[1869,1205],[305,1205]],"region":{"top_left_x":305,"top_left_y":1155,"width":1565,"height":51},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4dd073bb93e54f19971428465b13d259","type":"text","conversion_output":true,"text":"date that study personnel listed on the Delegation of Authority Log identify or are notified of","text_display":" date that study personnel listed on the Delegation of Authority Log identify or are notified of","confidence":1,"confidence_rate":1},{"cnt":[[305,1203],[475,1203],[475,1244],[305,1244]],"region":{"top_left_x":305,"top_left_y":1203,"width":170,"height":41},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a51bc9ea053f44ac92602bd0a9251339","type":"text","conversion_output":true,"text":"the event.","text_display":" the event.","confidence":1,"confidence_rate":1},{"cnt":[[309,1272],[1841,1272],[1841,1321],[309,1321]],"region":{"top_left_x":309,"top_left_y":1271,"width":1533,"height":51},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2212e4ae48b840ea91e3f58beea915fd","type":"text","conversion_output":true,"text":"Centers should report control device-related deficiencies as per requirements in the control-","text_display":"\n\nCenters should report control device-related deficiencies as per requirements in the control","confidence":1,"confidence_rate":1},{"cnt":[[309,1319],[784,1319],[784,1360],[309,1360]],"region":{"top_left_x":309,"top_left_y":1319,"width":476,"height":41},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"de1d4cc244a74afaae6c2a8df67b6311","type":"text","conversion_output":true,"text":"device Instructions For Use.","text_display":"device Instructions For Use.","confidence":0.978515625,"confidence_rate":0.9993420794351761},{"cnt":[[632,1401],[1553,1401],[1553,1448],[632,1448]],"region":{"top_left_x":631,"top_left_y":1400,"width":923,"height":49},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fdeb34a2c757433d92938b6eccec1195","type":"figure_label","conversion_output":false,"text":"Table 21.3-1: Investigator Reporting Requirements","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[288,1452],[1897,1452],[1897,2460],[288,2460]],"region":{"top_left_x":287,"top_left_y":1452,"width":1611,"height":1008},"line":39,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b0839d767c9a4fdb876f42ab5d2e069a","type":"table","conversion_output":true,"children_ids":["006f48da5c9f4af89cc65fd8b098bfe9","437af1aca558410e94d94e4770f8e024","ad1c887654c747a086fa27d2ed7120ca","919676af023d4c288e1541ed47d1e819","15ee9a6bbd864476b7db21d2c1c041cc","d2c00617461b44b3b36974761aeb2ce6","c1863284f34049328b8fa084ba5e16bd","5a0f4b218ad84fb4bba0fa04172e3491","967d809f2bfb493da89aa657a94f26cf","a47c900d31534318988cd14dd97a5597","c5b6d814e1f842978f765bea811d0806","5db948e7e2cd4a318da82fadfab543fe","9aef0abb9e3b4f8aa205577a50e36f1d","b2daa1b19b24473daa9a8d4f65778724","5ff766f913b34312a84c45ce35215af4","e7821cd854e44eda89b9597af6478f41","66bd68503eff482680c0abacb639f473","f611b82e61304c1cbcad18a76805bb2f","191b79891be94faa8486d346bad70d10","5eec85a05d824533a86d0c9c38e68f9c","b01fb44fcf284743a2be642a66402624","da4a43d9ba244e438575e2ba61ef5483","25f97db7b76245dda2824970d6d709c1","63caaa2b7cb842e9b3a4ed526d42c6bf","f13581b9269c4c51aa965d25e44d6fc7"],"selected_labels":["fdeb34a2c757433d92938b6eccec1195"],"text":"\\begin{tabular}{|l|l|l|}\n\\hline Event Classification & Communication Method & Communication Timeline \\\\\n\\hline \\multirow[t]{2}{*}{Unanticipated Adverse Device Effect / Unanticipated Serious Adverse Device Effect (UADE/USADE)} & Complete adverse event (AE) electronic case report form (eCRF) page with all available new and updated information & \\begin{tabular}{l}\n- Within 1 business day of first becoming aware of the event \\\\\n- Beginning from time of enrollment for all subjects \\\\\n- Terminating at the end of the study\n\\end{tabular} \\\\\n\\hline & Provide copies of all relevant source documents requested by BSC & - As soon as possible after reporting the event \\\\\n\\hline \\multirow[t]{2}{*}{Serious Adverse Event (SAE) including Serious Adverse Device Effects (SADE)} & Complete AE eCRF page with all available new and updated information & \\begin{tabular}{l}\n- Within 2 business days of first becoming aware of the event or as per local/regional regulations. \\\\\n- Beginning from time of enrollment for 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Term & Definition \\\\\n\\hline ACUTE KIDNEY INJURY (AKI) (AKIN System \\({ }^{109,110}\\) ) & \\begin{tabular}{l}\nChange in serum creatinine (up to 7 days) compared to baseline: \\\\\n- Stage 1: Increase in serum creatinine to \\(150-199 \\%(1.5-1.99 \\times\\) increase compared with baseline) OR increase of \\(\\geq 0.3 mg / dl (\\geq 26.4 mmol / L )\\) \\\\\n- Stage 2: Increase in serum creatinine to \\(200-299 \\%(2.0-2.99 \\times\\) increase compared with baseline) \\\\\n- Stage 3: Increase in serum creatinine to \\(\\geq 300 \\%\\) ( \\(>3 \\times\\) increase compared with baseline) OR serum creatinine of \\(\\geq 4.0 mg / dL (\\geq 354 mmol / L )\\) with an acute increase of at least \\(0.5 mg / dL (44 mmol / L )\\) \\\\\n-OR- \\\\\nBased on urine output (up to 7 days): \\\\\n- Stage 1: \\(<0.5 ml / kg\\) per hour for \\(>6\\) but \\(<12\\) hours \\\\\n- Stage 2: \\(<0.5 ml / kg\\) per hour for \\(>12\\) but \\(<24\\) hours \\\\\n- Stage 3: \\(<0.3 ml / kg\\) per hour for \\(\\geq 24\\) hours or anuria for \\(\\geq 12\\) hours \\\\\nNote 1: Subjects receiving renal replacement therapy are considered to meet Stage 3 criteria irrespective of other criteria.\n\\end{tabular} \\\\\n\\hline ACUTE VESSEL OCCLUSION & The state of complete luminal obstruction with no antegrade blood flow \\\\\n\\hline ADVERSE EVENT Ref: ISO 14155:2011 (AE) & \\begin{tabular}{l}\nAny untoward medical occurrence, unintended disease or injury or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. \\\\\nNote 1: This definition includes events related to the investigational medical device or the comparator. \\\\\nNote 2: This definition includes events related to the procedures involved. \\\\\nNote 3: For users or other persons, this definition is restricted to events related to investigational medical devices.\n\\end{tabular} \\\\\n\\hline ADVERSE EVENT BECOME AWARE DATE & The become aware date for an adverse event that requires reporting per the protocol is the date that study personnel listed on the Delegation of Authority Log identify or are notified of the event. \\\\\n\\hline \\begin{tabular}{l}\nADVERSE DEVICE EFFECT \\\\\nRef: ISO 14155:2011 (ADE)\n\\end{tabular} & \\begin{tabular}{l}\nAdverse event related to the use of an investigational medical device \\\\\nNote 1: This definition includes adverse events resulting from insufficient or inadequate instructions for use, deployment, implantation, installation, or operation, or any malfunction of the investigational medical device. \\\\\nNote 2: This definition includes any event resulting from use error or from intentional misuse of the investigational medical device.\n\\end{tabular} \\\\\n\\hline AORTIC DISSECTION & Intimal tear resulting in blood splitting the aortic media and producing a false lumen that can progress in an antegrade or retrograde direction Aortic dissection is further classified using Stanford classification (Types A and B depending on whether ascending or descending aorta involved) or DeBakey classification (Types \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Table 26.2-1: Definitions}\n\\begin{tabular}{|l|l|}\n\\hline Term & Definition \\\\\n\\hline ACUTE KIDNEY INJURY (AKI) (AKIN System \\({ }^{109,110}\\) ) & \\begin{tabular}{l}\nChange in serum creatinine (up to 7 days) compared to baseline: \\\\\n- Stage 1: Increase in serum creatinine to \\(150-199 \\%(1.5-1.99 \\times\\) increase compared with baseline) OR increase of \\(\\geq 0.3 mg / dl (\\geq 26.4 mmol / L )\\) \\\\\n- Stage 2: Increase in serum creatinine to \\(200-299 \\%(2.0-2.99 \\times\\) increase compared with baseline) \\\\\n- Stage 3: Increase in serum creatinine to \\(\\geq 300 \\%\\) ( \\(>3 \\times\\) increase compared with baseline) OR serum creatinine of \\(\\geq 4.0 mg / dL (\\geq 354 mmol / L )\\) with an acute increase of at least \\(0.5 mg / dL (44 mmol / L )\\) \\\\\n-OR- \\\\\nBased on urine output (up to 7 days): \\\\\n- Stage 1: \\(<0.5 ml / kg\\) per hour for \\(>6\\) but \\(<12\\) hours \\\\\n- Stage 2: \\(<0.5 ml / kg\\) per hour for \\(>12\\) but \\(<24\\) hours \\\\\n- Stage 3: \\(<0.3 ml / kg\\) per hour for \\(\\geq 24\\) hours or anuria for \\(\\geq 12\\) hours \\\\\nNote 1: Subjects receiving renal replacement therapy are considered to meet Stage 3 criteria irrespective of other criteria.\n\\end{tabular} \\\\\n\\hline ACUTE VESSEL OCCLUSION & The state of complete luminal obstruction with no antegrade blood flow \\\\\n\\hline ADVERSE EVENT Ref: ISO 14155:2011 (AE) & \\begin{tabular}{l}\nAny untoward medical occurrence, unintended disease or injury or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. \\\\\nNote 1: This definition includes events related to the investigational medical device or the comparator. \\\\\nNote 2: This definition includes events related to the procedures involved. \\\\\nNote 3: For users or other persons, this definition is restricted to events related to investigational medical devices.\n\\end{tabular} \\\\\n\\hline ADVERSE EVENT BECOME AWARE DATE & The become aware date for an adverse event that requires reporting per the protocol is the date that study personnel listed on the Delegation of Authority Log identify or are notified of the event. \\\\\n\\hline \\begin{tabular}{l}\nADVERSE DEVICE EFFECT \\\\\nRef: ISO 14155:2011 (ADE)\n\\end{tabular} & \\begin{tabular}{l}\nAdverse event related to the use of an investigational medical device \\\\\nNote 1: This definition includes adverse events resulting from insufficient or inadequate instructions for use, deployment, implantation, installation, or operation, or any malfunction of the investigational medical device. \\\\\nNote 2: This definition includes any event resulting from use error or from intentional misuse of the investigational medical device.\n\\end{tabular} \\\\\n\\hline AORTIC DISSECTION & Intimal tear resulting in blood splitting the aortic media and producing a false lumen that can progress in an antegrade or retrograde direction Aortic dissection is further classified using Stanford classification (Types A and B depending on whether ascending or descending aorta involved) or DeBakey classification (Types 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Unauthorized use is prohibitedage 123 of 188","text_display":"","confidence":0.8742058277130127,"confidence_rate":0.9983815589190452}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"40f68f98-216b-48da-9b91-d6ee4b323748-124","page":124,"lines":[{"cnt":[[309,129],[423,129],[423,165],[309,165]],"region":{"top_left_x":309,"top_left_y":128,"width":115,"height":38},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a823877152d240eba4a510ac75411cc5","type":"page_info","conversion_output":false,"text":"S2282","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1581,129],[1880,129],[1880,170],[1581,170]],"region":{"top_left_x":1581,"top_left_y":128,"width":299,"height":42},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b9536b14e04a485b8035c0cf5216ec3a","type":"page_info","conversion_output":false,"text":"Boston 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Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1482,223],[1880,223],[1880,264],[1482,264]],"region":{"top_left_x":1482,"top_left_y":223,"width":398,"height":42},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bd2f3f264d6847178e09d4dc6a314a26","type":"page_info","conversion_output":false,"text":"90899936 Rev/Ver AK","text_display":"","confidence":0.9990234375,"confidence_rate":0.9999575209175736},{"cnt":[[1598,271],[1880,271],[1880,320],[1598,320]],"region":{"top_left_x":1598,"top_left_y":270,"width":282,"height":51},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dc68bd0d5ae34827a494d2a20f3cfabb","type":"page_info","conversion_output":false,"text":"Page 124 of 188","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[868,352],[1317,352],[1317,393],[868,393]],"region":{"top_left_x":867,"top_left_y":352,"width":450,"height":42},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6091bf3e57d04f59a97fbb6dba05ac2f","type":"figure_label","conversion_output":false,"text":"Table 26.2-1: Definitions","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[288,402],[1899,402],[1899,2488],[288,2488]],"region":{"top_left_x":287,"top_left_y":401,"width":1613,"height":2087},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7d585eb25bfa4879a092596dd4be6702","type":"table","conversion_output":true,"children_ids":["b836356a67ab413285b44a2533b24efb","96a3e28308e140d59281ada78bea2ea0","ee3498cb2575455ebc0d9b21c7beb2e6","6d37b06f8e454d0f8d1ec45e6e59f198","de13b06cb6e84fb2aec595f8c31b0648","99279d5e74224c528922afa5f5ac5d2f","d2dbe7cde0d9406a91cfabd15a95dd49","817bbc8e13ca4fe8b6d6bddffd77b1e6","eee2fb96a9ef46458dc05ad964f7842f","291e9df450404b46ac62e1c9afedade4","1d066736a7014ce1b0617f56bcb331c9","34b08365a75c495ebbbbbabd2b990bd6","d9a356b2525c4a198b6585a9019b73a3","2437701f2ba843e98848639b38fd1450","98ddd0f2ff9d42cd8ae864e617352f99","5ad299da43934b369338a9da67ac5c45"],"selected_labels":["6091bf3e57d04f59a97fbb6dba05ac2f"],"text":"\\begin{tabular}{|l|l|}\n\\hline Term & Definition \\\\\n\\hline & \\begin{tabular}{l}\nI, II and III) [see Figure below].![](https://cdn.mathpix.com/cropped/40f68f98-216b-48da-9b91-d6ee4b323748-124.jpg?height=460\\&width=341\\&top_left_y=522\\&top_left_x=741)\nI![](https://cdn.mathpix.com/cropped/40f68f98-216b-48da-9b91-d6ee4b323748-124.jpg?height=462\\&width=320\\&top_left_y=522\\&top_left_x=1109)\nII![](https://cdn.mathpix.com/cropped/40f68f98-216b-48da-9b91-d6ee4b323748-124.jpg?height=465\\&width=324\\&top_left_y=517\\&top_left_x=1512)\nIII \\\\\nType A\nType B\n\\end{tabular} \\\\\n\\hline AORTIC REGURGITATION (AR) & \\begin{tabular}{l}\nThe leaking of the aortic valve that causes blood to flow in the reverse direction during ventricular diastole, from the aorta into the left ventricle. \\\\\nThe echocardiographic findings in severe aortic regurgitation include the following. \\\\\n- An AR color jet dimension \\(>60 \\%\\) of the left ventricular outflow tract diameter (may not be true if the jet is eccentric) \\\\\n- The pressure half-time of the regurgitant jet is \\(<250 msec\\) \\\\\n- Early termination of the mitral inflow (due to increase in LV pressure due to the AR) \\\\\n- Early diastolic flow reversal in the descending aorta. \\\\\n- Regurgitant volume \\(>60 mL\\) \\\\\n- Regurgitant fraction >55\\%\n\\end{tabular} \\\\\n\\hline ARRHYTHMIA & \\begin{tabular}{l}\nAny variation from the normal rhythm of the heartbeat, including sinus arrhythmia, premature beat, heart block, atrial fibrillation, atrial flutter and tachycardia. Complete heart block, ventricular tachycardia and ventricular fibrillation are considered major arrhythmias. Data should be collected on any new arrhythmia resulting in hemodynamic instability or requiring therapy (therapy includes electrical/medical cardioversion or initiation of a new medication [oral anticoagulation, rhythm or rate controlling therapy]). \\\\\nNew onset atrial fibrillation or atrial flutter (AF) is diagnosed as any arrhythmia within hospitalization that has the ECG characteristics of AF and lasts sufficiently long to be recorded on a 12-lead ECG, or at least 30 seconds on a rhythm strip. The therapeutic approach to new-onset AF (spontaneous conversion, electrical or medical cardioversion, initiation of oral anticoagulation, and rate or rhythm control medications) and any clinical consequences should be documented. \\\\\nNote 1: See also definitions for conductance disturbance and permanent pacemaker.\n\\end{tabular} \\\\\n\\hline AS-TREATED ANALYSIS SET & This population includes all subjects who sign an Informed Consent Form, are enrolled in the trial, are randomized, and receive a study device, but subjects are analyzed based on the treatment actually received. For example, if a subject is assigned to receive a test device but instead receives a control device, that subject will be considered a control subject for the as-treated analyses of implant subgroups. \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Table 26.2-1: Definitions}\n\\begin{tabular}{|l|l|}\n\\hline Term & Definition \\\\\n\\hline & \\begin{tabular}{l}\nI, II and III) [see Figure below].![](https://cdn.mathpix.com/cropped/40f68f98-216b-48da-9b91-d6ee4b323748-124.jpg?height=460\\&width=341\\&top_left_y=522\\&top_left_x=741)\nI![](https://cdn.mathpix.com/cropped/40f68f98-216b-48da-9b91-d6ee4b323748-124.jpg?height=462\\&width=320\\&top_left_y=522\\&top_left_x=1109)\nII![](https://cdn.mathpix.com/cropped/40f68f98-216b-48da-9b91-d6ee4b323748-124.jpg?height=465\\&width=324\\&top_left_y=517\\&top_left_x=1512)\nIII \\\\\nType A\nType B\n\\end{tabular} \\\\\n\\hline AORTIC REGURGITATION (AR) & \\begin{tabular}{l}\nThe leaking of the aortic valve that causes blood to flow in the reverse direction during ventricular diastole, from the aorta into the left ventricle. \\\\\nThe echocardiographic findings in severe aortic regurgitation include the following. \\\\\n- An AR color jet dimension \\(>60 \\%\\) of the left ventricular outflow tract diameter (may not be true if the jet is eccentric) \\\\\n- The pressure half-time of the regurgitant jet is \\(<250 msec\\) \\\\\n- Early termination of the mitral inflow (due to increase in LV pressure due to the AR) \\\\\n- Early diastolic flow reversal in the descending aorta. \\\\\n- Regurgitant volume \\(>60 mL\\) \\\\\n- Regurgitant fraction >55\\%\n\\end{tabular} \\\\\n\\hline ARRHYTHMIA & \\begin{tabular}{l}\nAny variation from the normal rhythm of the heartbeat, including sinus arrhythmia, premature beat, heart block, atrial fibrillation, atrial flutter and tachycardia. Complete heart block, ventricular tachycardia and ventricular fibrillation are considered major arrhythmias. Data should be collected on any new arrhythmia resulting in hemodynamic instability or requiring therapy (therapy includes electrical/medical cardioversion or initiation of a new medication [oral anticoagulation, rhythm or rate controlling therapy]). \\\\\nNew onset atrial fibrillation or atrial flutter (AF) is diagnosed as any arrhythmia within hospitalization that has the ECG characteristics of AF and lasts sufficiently long to be recorded on a 12-lead ECG, or at least 30 seconds on a rhythm strip. The therapeutic approach to new-onset AF (spontaneous conversion, electrical or medical cardioversion, initiation of oral anticoagulation, and rate or rhythm control medications) and any clinical consequences should be documented. \\\\\nNote 1: See also definitions for conductance disturbance and permanent pacemaker.\n\\end{tabular} \\\\\n\\hline AS-TREATED ANALYSIS SET & This population includes all subjects who sign an Informed Consent Form, are enrolled in the trial, are randomized, and receive a study device, but subjects are analyzed based on the treatment actually received. For example, if a subject is assigned to receive a test device but instead receives a control device, that subject will be considered a control subject for the as-treated analyses of implant subgroups. \\\\\n\\hline\n\\end{tabular}\n\\end{table}","confidence":0.9150390625,"confidence_rate":0.9999711038441282},{"cnt":[[298,401],[607,401],[607,2489],[298,2489]],"region":{"top_left_x":297,"top_left_y":401,"width":311,"height":2088},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b836356a67ab413285b44a2533b24efb","type":"table_column","conversion_output":false,"parent_id":"7d585eb25bfa4879a092596dd4be6702","text":"","text_display":""},{"cnt":[[691,2489],[693,400],[1892,401],[1889,2490]],"region":{"top_left_x":690,"top_left_y":399,"width":1202,"height":2091},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"96a3e28308e140d59281ada78bea2ea0","type":"table_column","conversion_output":false,"parent_id":"7d585eb25bfa4879a092596dd4be6702","text":"","text_display":""},{"cnt":[[287,407],[1900,407],[1900,455],[287,455]],"region":{"top_left_x":287,"top_left_y":407,"width":1614,"height":49},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ee3498cb2575455ebc0d9b21c7beb2e6","type":"table_row","conversion_output":false,"parent_id":"7d585eb25bfa4879a092596dd4be6702","text":"","text_display":""},{"cnt":[[287,455],[1900,455],[1900,1168],[287,1168]],"region":{"top_left_x":287,"top_left_y":455,"width":1614,"height":713},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6d37b06f8e454d0f8d1ec45e6e59f198","type":"table_row","conversion_output":false,"parent_id":"7d585eb25bfa4879a092596dd4be6702","text":"","text_display":""},{"cnt":[[287,1170],[1900,1170],[1900,1661],[287,1661]],"region":{"top_left_x":287,"top_left_y":1169,"width":1614,"height":493},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"de13b06cb6e84fb2aec595f8c31b0648","type":"table_row","conversion_output":false,"parent_id":"7d585eb25bfa4879a092596dd4be6702","text":"","text_display":""},{"cnt":[[287,1659],[1900,1659],[1900,2242],[287,2242]],"region":{"top_left_x":287,"top_left_y":1659,"width":1614,"height":583},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"99279d5e74224c528922afa5f5ac5d2f","type":"table_row","conversion_output":false,"parent_id":"7d585eb25bfa4879a092596dd4be6702","text":"","text_display":""},{"cnt":[[287,2237],[1900,2237],[1900,2489],[287,2489]],"region":{"top_left_x":287,"top_left_y":2237,"width":1614,"height":252},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d2dbe7cde0d9406a91cfabd15a95dd49","type":"table_row","conversion_output":false,"parent_id":"7d585eb25bfa4879a092596dd4be6702","text":"","text_display":""},{"cnt":[[309,414],[397,414],[397,446],[309,446]],"region":{"top_left_x":308,"top_left_y":413,"width":90,"height":34},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"817bbc8e13ca4fe8b6d6bddffd77b1e6","type":"simple_cell","conversion_output":false,"parent_id":"7d585eb25bfa4879a092596dd4be6702","text":"Term","text_display":"Term","cell_row":0,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[703,414],[857,414],[857,446],[703,446]],"region":{"top_left_x":702,"top_left_y":413,"width":155,"height":34},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"eee2fb96a9ef46458dc05ad964f7842f","type":"simple_cell","conversion_output":false,"parent_id":"7d585eb25bfa4879a092596dd4be6702","text":"Definition","text_display":"Definition","cell_row":0,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[703,457],[1859,457],[1859,1161],[703,1161]],"region":{"top_left_x":702,"top_left_y":457,"width":1158,"height":705},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"291e9df450404b46ac62e1c9afedade4","type":"complex_cell","conversion_output":false,"parent_id":"7d585eb25bfa4879a092596dd4be6702","children_ids":["b1d55f05e42e4061a169b1cefa4d394a","ff7c97f7453144b18ac00ce4bb28f22b","5d117dcd01e34a1aa1fc6ec4f672e677","6183f3ab05344d40ab13f65f3c369925","858ccd3802d84efb9285d5c68babe177","3a31e63ae08c4fa9b898d3dff4a10f9b"],"text":"\\begin{tabular}{l}\nI, II and III) [see Figure below].![](https://cdn.mathpix.com/cropped/40f68f98-216b-48da-9b91-d6ee4b323748-124.jpg?height=460\\&width=341\\&top_left_y=522\\&top_left_x=741)\nI![](https://cdn.mathpix.com/cropped/40f68f98-216b-48da-9b91-d6ee4b323748-124.jpg?height=462\\&width=320\\&top_left_y=522\\&top_left_x=1109)\nII![](https://cdn.mathpix.com/cropped/40f68f98-216b-48da-9b91-d6ee4b323748-124.jpg?height=465\\&width=324\\&top_left_y=517\\&top_left_x=1512)\nIII \\\\\nType A\nType B\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nI, II and III) [see Figure below].![](https://cdn.mathpix.com/cropped/40f68f98-216b-48da-9b91-d6ee4b323748-124.jpg?height=460\\&width=341\\&top_left_y=522\\&top_left_x=741)\nI![](https://cdn.mathpix.com/cropped/40f68f98-216b-48da-9b91-d6ee4b323748-124.jpg?height=462\\&width=320\\&top_left_y=522\\&top_left_x=1109)\nII![](https://cdn.mathpix.com/cropped/40f68f98-216b-48da-9b91-d6ee4b323748-124.jpg?height=465\\&width=324\\&top_left_y=517\\&top_left_x=1512)\nIII \\\\\nType A\nType B\n\\end{tabular}","cell_row":1,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[703,459],[1151,459],[1151,498],[703,498]],"region":{"top_left_x":702,"top_left_y":459,"width":450,"height":40},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b1d55f05e42e4061a169b1cefa4d394a","type":"text","conversion_output":false,"parent_id":"291e9df450404b46ac62e1c9afedade4","text":"I, II and III) [see Figure below].","text_display":"I, II and III) [see Figure 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A","text_display":"\nType A","confidence":1,"confidence_rate":1},{"cnt":[[1530,1111],[1634,1111],[1634,1144],[1530,1144]],"region":{"top_left_x":1529,"top_left_y":1111,"width":105,"height":33},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3a31e63ae08c4fa9b898d3dff4a10f9b","type":"figure_label","conversion_output":false,"parent_id":"291e9df450404b46ac62e1c9afedade4","text":"Type B","text_display":"\nType B","confidence":1,"confidence_rate":1},{"cnt":[[306,1176],[601,1176],[601,1300],[306,1300]],"region":{"top_left_x":306,"top_left_y":1176,"width":295,"height":124},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1d066736a7014ce1b0617f56bcb331c9","type":"complex_cell","conversion_output":false,"parent_id":"7d585eb25bfa4879a092596dd4be6702","children_ids":["59d50d15465542f9a19d471a3ffdad67","1326b4cfba844ef8b62d1af989ccdefe","af6ead17049342eeb03476a041b5ad19"],"text":"AORTIC REGURGITATION (AR)","text_display":"AORTIC REGURGITATION (AR)","cell_row":2,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[309,1181],[445,1181],[445,1209],[309,1209]],"region":{"top_left_x":308,"top_left_y":1180,"width":138,"height":29},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"59d50d15465542f9a19d471a3ffdad67","type":"text","conversion_output":false,"parent_id":"1d066736a7014ce1b0617f56bcb331c9","text":"AORTIC","text_display":"AORTIC","confidence":1,"confidence_rate":1},{"cnt":[[309,1220],[601,1220],[601,1252],[309,1252]],"region":{"top_left_x":308,"top_left_y":1219,"width":293,"height":34},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1326b4cfba844ef8b62d1af989ccdefe","type":"text","conversion_output":false,"parent_id":"1d066736a7014ce1b0617f56bcb331c9","text":"REGURGITATION","text_display":" REGURGITATION","confidence":1,"confidence_rate":1},{"cnt":[[309,1259],[387,1259],[387,1298],[309,1298]],"region":{"top_left_x":308,"top_left_y":1258,"width":79,"height":40},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"af6ead17049342eeb03476a041b5ad19","type":"text","conversion_output":false,"parent_id":"1d066736a7014ce1b0617f56bcb331c9","text":"(AR)","text_display":" (AR)","confidence":1,"confidence_rate":1},{"cnt":[[698,1172],[1874,1172],[1874,1659],[698,1659]],"region":{"top_left_x":698,"top_left_y":1171,"width":1177,"height":489},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"34b08365a75c495ebbbbbabd2b990bd6","type":"complex_cell","conversion_output":false,"parent_id":"7d585eb25bfa4879a092596dd4be6702","children_ids":["9c74227a9ed0466cb5738a2b143fe5e4","c8dd2dddab9a4029badcc9b26145e411","a366b835ad20401982d4b53f52726fe1","f28eb0f2c8f84c9cba0ba2773202d64d","db8735ace256427c872edd28f98db2b8","708f716cfa3746cabd778556d77b74f5","6ff470c161454a9f949118de29b51b8a","b2605141946246698672bacd110c4806","e1027b0f4b26437abfa70b270674c4ca","74b3f6089c3b453bbf0b22235910e8cf","b2cb00a60c9842e387f27a1a58b10a80"],"text":"\\begin{tabular}{l}\nThe leaking of the aortic valve that causes blood to flow in the reverse direction during ventricular diastole, from the aorta into the left ventricle. \\\\\nThe echocardiographic findings in severe aortic regurgitation include the following. \\\\\n- An AR color jet dimension \\(>60 \\%\\) of the left ventricular outflow tract diameter (may not be true if the jet is eccentric) \\\\\n- The pressure half-time of the regurgitant jet is \\(<250 msec\\) \\\\\n- Early termination of the mitral inflow (due to increase in LV pressure due to the AR) \\\\\n- Early diastolic flow reversal in the descending aorta. \\\\\n- Regurgitant volume \\(>60 mL\\) \\\\\n- Regurgitant fraction >55\\%\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nThe leaking of the aortic valve that causes blood to flow in the reverse direction during ventricular diastole, from the aorta into the left ventricle. \\\\\nThe echocardiographic findings in severe aortic regurgitation include the following. \\\\\n- An AR color jet dimension \\(>60 \\%\\) of the left ventricular outflow tract diameter (may not be true if the jet is eccentric) \\\\\n- The pressure half-time of the regurgitant jet is \\(<250 msec\\) \\\\\n- Early termination of the mitral inflow (due to increase in LV pressure due to the AR) \\\\\n- Early diastolic flow reversal in the descending aorta. \\\\\n- Regurgitant volume \\(>60 mL\\) \\\\\n- Regurgitant fraction >55\\%\n\\end{tabular}","cell_row":2,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.93896484375,"confidence_rate":0.9998170430609122},{"cnt":[[703,1176],[1818,1176],[1818,1217],[703,1217]],"region":{"top_left_x":702,"top_left_y":1176,"width":1117,"height":42},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9c74227a9ed0466cb5738a2b143fe5e4","type":"text","conversion_output":false,"parent_id":"34b08365a75c495ebbbbbabd2b990bd6","text":"The leaking of the aortic valve that causes blood to flow in the reverse direction","text_display":"The leaking of the aortic valve that causes blood to flow in the reverse direction","confidence":1,"confidence_rate":1},{"cnt":[[703,1220],[1597,1220],[1597,1259],[703,1259]],"region":{"top_left_x":702,"top_left_y":1219,"width":896,"height":40},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c8dd2dddab9a4029badcc9b26145e411","type":"text","conversion_output":false,"parent_id":"34b08365a75c495ebbbbbabd2b990bd6","text":"during ventricular diastole, from the aorta into the left ventricle.","text_display":" during ventricular diastole, from the aorta into the left ventricle.","confidence":1,"confidence_rate":1},{"cnt":[[703,1263],[1872,1263],[1872,1304],[703,1304]],"region":{"top_left_x":702,"top_left_y":1262,"width":1171,"height":43},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a366b835ad20401982d4b53f52726fe1","type":"text","conversion_output":false,"parent_id":"34b08365a75c495ebbbbbabd2b990bd6","text":"The echocardiographic findings in severe aortic regurgitation include the following.","text_display":"\nThe echocardiographic findings in severe aortic regurgitation include the following.","confidence":1,"confidence_rate":1},{"cnt":[[703,1306],[1835,1306],[1835,1347],[703,1347]],"region":{"top_left_x":702,"top_left_y":1306,"width":1134,"height":42},"line":39,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f28eb0f2c8f84c9cba0ba2773202d64d","type":"text","conversion_output":false,"parent_id":"34b08365a75c495ebbbbbabd2b990bd6","text":"- An AR color jet dimension \\(>60 \\%\\) of the left ventricular outflow tract diameter","text_display":"\n- An AR color jet dimension \\(>60 \\%\\) of the left ventricular outflow tract diameter","confidence":0.998046875,"confidence_rate":0.9999775285877066},{"cnt":[[742,1347],[1277,1347],[1277,1391],[742,1391]],"region":{"top_left_x":741,"top_left_y":1347,"width":536,"height":44},"line":40,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"db8735ace256427c872edd28f98db2b8","type":"text","conversion_output":false,"parent_id":"34b08365a75c495ebbbbbabd2b990bd6","text":"(may not be true if the jet is eccentric)","text_display":" (may not be true if the jet is eccentric)","confidence":1,"confidence_rate":1},{"cnt":[[705,1393],[1547,1393],[1547,1434],[705,1434]],"region":{"top_left_x":704,"top_left_y":1392,"width":844,"height":42},"line":41,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"708f716cfa3746cabd778556d77b74f5","type":"text","conversion_output":false,"parent_id":"34b08365a75c495ebbbbbabd2b990bd6","text":"- The pressure half-time of the regurgitant jet is \\(<250 msec\\)","text_display":"\n- The pressure half-time of the regurgitant jet is \\(<250 msec\\)","confidence":0.99951171875,"confidence_rate":0.9999926000198329},{"cnt":[[705,1436],[1859,1436],[1859,1479],[705,1479]],"region":{"top_left_x":704,"top_left_y":1436,"width":1156,"height":44},"line":42,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6ff470c161454a9f949118de29b51b8a","type":"text","conversion_output":false,"parent_id":"34b08365a75c495ebbbbbabd2b990bd6","text":"- Early termination of the mitral inflow (due to increase in LV pressure due to the","text_display":"\n- Early termination of the mitral inflow (due to increase in LV pressure due to the","confidence":1,"confidence_rate":1},{"cnt":[[742,1479],[811,1479],[811,1521],[742,1521]],"region":{"top_left_x":741,"top_left_y":1479,"width":71,"height":42},"line":43,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b2605141946246698672bacd110c4806","type":"text","conversion_output":false,"parent_id":"34b08365a75c495ebbbbbabd2b990bd6","text":"AR)","text_display":" AR)","confidence":1,"confidence_rate":1},{"cnt":[[705,1523],[1476,1523],[1476,1566],[705,1566]],"region":{"top_left_x":704,"top_left_y":1522,"width":772,"height":45},"line":44,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e1027b0f4b26437abfa70b270674c4ca","type":"text","conversion_output":false,"parent_id":"34b08365a75c495ebbbbbabd2b990bd6","text":"- Early diastolic flow reversal in the descending aorta.","text_display":"\n- Early diastolic flow reversal in the descending aorta.","confidence":1,"confidence_rate":1},{"cnt":[[705,1570],[1142,1570],[1142,1612],[705,1612]],"region":{"top_left_x":704,"top_left_y":1570,"width":439,"height":42},"line":45,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"74b3f6089c3b453bbf0b22235910e8cf","type":"text","conversion_output":false,"parent_id":"34b08365a75c495ebbbbbabd2b990bd6","text":"- Regurgitant volume \\(>60 mL\\)","text_display":"\n- Regurgitant volume \\(>60 mL\\)","confidence":0.99951171875,"confidence_rate":0.9999852000944255},{"cnt":[[705,1618],[1121,1618],[1121,1657],[705,1657]],"region":{"top_left_x":704,"top_left_y":1618,"width":417,"height":39},"line":46,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b2cb00a60c9842e387f27a1a58b10a80","type":"text","conversion_output":false,"parent_id":"34b08365a75c495ebbbbbabd2b990bd6","text":"- Regurgitant fraction >55\\%","text_display":"\n- Regurgitant fraction >55\\%","confidence":0.93896484375,"confidence_rate":0.9980338965506619},{"cnt":[[309,1666],[551,1666],[551,1702],[309,1702]],"region":{"top_left_x":308,"top_left_y":1665,"width":244,"height":38},"line":47,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d9a356b2525c4a198b6585a9019b73a3","type":"simple_cell","conversion_output":false,"parent_id":"7d585eb25bfa4879a092596dd4be6702","text":"ARRHYTHMIA","text_display":"ARRHYTHMIA","cell_row":3,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[698,1661],[1876,1661],[1876,2240],[698,2240]],"region":{"top_left_x":698,"top_left_y":1661,"width":1179,"height":579},"line":48,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2437701f2ba843e98848639b38fd1450","type":"complex_cell","conversion_output":false,"parent_id":"7d585eb25bfa4879a092596dd4be6702","children_ids":["13c00d0d69d74eb1bcf31a142cf1ee58","4459add045fe4d7c9c9a32bdc4c94d09","ec5c3ef74e3a4d919b844d2eb4a81a7e","a7de940fb62244269aa7a42aef96791b","410138d37f3c43878530014d825b1a9f","98edb30a394f472f9690a8c9777ff214","bb8279848a064bc8b5dca3f2121f8470","40361ffb3af24875bba486826eee76a4","737b723caf874ddaa079aeb03e0ebf99","4ba75c5c4f6c428fac26d379b95d131d","329a8a40755a446dacab1d18edef84e5","7a40db87da6b4f62972540bc3629ffcf","579f833eced74ae6a632a5dc2785cf5c","f39b30acfc7b48d9ac00141bac197d15"],"text":"\\begin{tabular}{l}\nAny variation from the normal rhythm of the heartbeat, including sinus arrhythmia, premature beat, heart block, atrial fibrillation, atrial flutter and tachycardia. Complete heart block, ventricular tachycardia and ventricular fibrillation are considered major arrhythmias. Data should be collected on any new arrhythmia resulting in hemodynamic instability or requiring therapy (therapy includes electrical/medical cardioversion or initiation of a new medication [oral anticoagulation, rhythm or rate controlling therapy]). \\\\\nNew onset atrial fibrillation or atrial flutter (AF) is diagnosed as any arrhythmia within hospitalization that has the ECG characteristics of AF and lasts sufficiently long to be recorded on a 12-lead ECG, or at least 30 seconds on a rhythm strip. The therapeutic approach to new-onset AF (spontaneous conversion, electrical or medical cardioversion, initiation of oral anticoagulation, and rate or rhythm control medications) and any clinical consequences should be documented. \\\\\nNote 1: See also definitions for conductance disturbance and permanent pacemaker.\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nAny variation from the normal rhythm of the heartbeat, including sinus arrhythmia, premature beat, heart block, atrial fibrillation, atrial flutter and tachycardia. Complete heart block, ventricular tachycardia and ventricular fibrillation are considered major arrhythmias. Data should be collected on any new arrhythmia resulting in hemodynamic instability or requiring therapy (therapy includes electrical/medical cardioversion or initiation of a new medication [oral anticoagulation, rhythm or rate controlling therapy]). \\\\\nNew onset atrial fibrillation or atrial flutter (AF) is diagnosed as any arrhythmia within hospitalization that has the ECG characteristics of AF and lasts sufficiently long to be recorded on a 12-lead ECG, or at least 30 seconds on a rhythm strip. The therapeutic approach to new-onset AF (spontaneous conversion, electrical or medical cardioversion, initiation of oral anticoagulation, and rate or rhythm control medications) and any clinical consequences should be documented. \\\\\nNote 1: See also definitions for conductance disturbance and permanent pacemaker.\n\\end{tabular}","cell_row":3,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.9150390625,"confidence_rate":0.9999229074891672},{"cnt":[[703,1666],[1866,1666],[1866,1707],[703,1707]],"region":{"top_left_x":702,"top_left_y":1665,"width":1164,"height":42},"line":49,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"13c00d0d69d74eb1bcf31a142cf1ee58","type":"text","conversion_output":false,"parent_id":"2437701f2ba843e98848639b38fd1450","text":"Any variation from the normal rhythm of the heartbeat, including sinus arrhythmia,","text_display":"Any variation from the normal rhythm of the heartbeat, including sinus arrhythmia,","confidence":1,"confidence_rate":1},{"cnt":[[703,1705],[1751,1705],[1751,1746],[703,1746]],"region":{"top_left_x":702,"top_left_y":1704,"width":1049,"height":42},"line":50,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4459add045fe4d7c9c9a32bdc4c94d09","type":"text","conversion_output":false,"parent_id":"2437701f2ba843e98848639b38fd1450","text":"premature beat, heart block, atrial fibrillation, atrial flutter and tachycardia.","text_display":" premature beat, heart block, atrial fibrillation, atrial flutter and tachycardia.","confidence":1,"confidence_rate":1},{"cnt":[[703,1744],[1770,1744],[1770,1785],[703,1785]],"region":{"top_left_x":702,"top_left_y":1743,"width":1069,"height":42},"line":51,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ec5c3ef74e3a4d919b844d2eb4a81a7e","type":"text","conversion_output":false,"parent_id":"2437701f2ba843e98848639b38fd1450","text":"Complete heart block, ventricular tachycardia and ventricular fibrillation are","text_display":" Complete heart block, ventricular tachycardia and ventricular fibrillation are","confidence":1,"confidence_rate":1},{"cnt":[[703,1783],[1814,1783],[1814,1826],[703,1826]],"region":{"top_left_x":702,"top_left_y":1782,"width":1112,"height":44},"line":52,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a7de940fb62244269aa7a42aef96791b","type":"text","conversion_output":false,"parent_id":"2437701f2ba843e98848639b38fd1450","text":"considered major arrhythmias. Data should be collected on any new arrhythmia","text_display":" considered major arrhythmias. Data should be collected on any new arrhythmia","confidence":1,"confidence_rate":1},{"cnt":[[703,1824],[1755,1824],[1755,1867],[703,1867]],"region":{"top_left_x":702,"top_left_y":1823,"width":1054,"height":45},"line":53,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"410138d37f3c43878530014d825b1a9f","type":"text","conversion_output":false,"parent_id":"2437701f2ba843e98848639b38fd1450","text":"resulting in hemodynamic instability or requiring therapy (therapy includes","text_display":" resulting in hemodynamic instability or requiring therapy (therapy includes","confidence":1,"confidence_rate":1},{"cnt":[[703,1865],[1692,1865],[1692,1906],[703,1906]],"region":{"top_left_x":702,"top_left_y":1864,"width":991,"height":43},"line":54,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"98edb30a394f472f9690a8c9777ff214","type":"text","conversion_output":false,"parent_id":"2437701f2ba843e98848639b38fd1450","text":"electrical/medical cardioversion or initiation of a new medication [oral","text_display":" electrical/medical cardioversion or initiation of a new medication [oral","confidence":1,"confidence_rate":1},{"cnt":[[703,1904],[1446,1904],[1446,1945],[703,1945]],"region":{"top_left_x":702,"top_left_y":1903,"width":744,"height":42},"line":55,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bb8279848a064bc8b5dca3f2121f8470","type":"text","conversion_output":false,"parent_id":"2437701f2ba843e98848639b38fd1450","text":"anticoagulation, rhythm or rate controlling therapy]).","text_display":" anticoagulation, rhythm or rate controlling therapy]).","confidence":1,"confidence_rate":1},{"cnt":[[703,1947],[1822,1947],[1822,1988],[703,1988]],"region":{"top_left_x":702,"top_left_y":1947,"width":1121,"height":42},"line":56,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"40361ffb3af24875bba486826eee76a4","type":"text","conversion_output":false,"parent_id":"2437701f2ba843e98848639b38fd1450","text":"New onset atrial fibrillation or atrial flutter (AF) is diagnosed as any arrhythmia","text_display":"\nNew onset atrial fibrillation or atrial flutter (AF) is diagnosed as any arrhythmia","confidence":0.99951171875,"confidence_rate":0.999994450009741},{"cnt":[[703,1986],[1853,1986],[1853,2032],[703,2032]],"region":{"top_left_x":702,"top_left_y":1986,"width":1151,"height":46},"line":57,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"737b723caf874ddaa079aeb03e0ebf99","type":"text","conversion_output":false,"parent_id":"2437701f2ba843e98848639b38fd1450","text":"within hospitalization that has the ECG characteristics of AF and lasts sufficiently","text_display":" within hospitalization that has the ECG characteristics of AF and lasts sufficiently","confidence":0.99951171875,"confidence_rate":0.9999945123690109},{"cnt":[[703,2025],[1807,2025],[1807,2071],[703,2071]],"region":{"top_left_x":702,"top_left_y":2025,"width":1106,"height":46},"line":58,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4ba75c5c4f6c428fac26d379b95d131d","type":"text","conversion_output":false,"parent_id":"2437701f2ba843e98848639b38fd1450","text":"long to be recorded on a 12-lead ECG, or at least 30 seconds on a rhythm strip.","text_display":" long to be recorded on a 12-lead ECG, or at least 30 seconds on a rhythm 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cardioversion, initiation of oral anticoagulation, and rate or rhythm control","text_display":" medical cardioversion, initiation of oral anticoagulation, and rate or rhythm control","confidence":1,"confidence_rate":1},{"cnt":[[703,2151],[1645,2151],[1645,2192],[703,2192]],"region":{"top_left_x":702,"top_left_y":2150,"width":943,"height":42},"line":61,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"579f833eced74ae6a632a5dc2785cf5c","type":"text","conversion_output":false,"parent_id":"2437701f2ba843e98848639b38fd1450","text":"medications) and any clinical consequences should be documented.","text_display":" medications) and any clinical consequences should be 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For example, if a subject is assigned to receive a test device but instead receives a control device, that subject will be considered a control subject for the as-treated analyses of implant subgroups.","text_display":"This population includes all subjects who sign an Informed Consent Form, are enrolled in the trial, are randomized, and receive a study device, but subjects are analyzed based on the treatment actually received. For example, if a subject is assigned to receive a test device but instead receives a control device, that subject will be considered a control subject for the as-treated analyses of implant subgroups.","cell_row":4,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[703,2244],[1796,2244],[1796,2283],[703,2283]],"region":{"top_left_x":702,"top_left_y":2243,"width":1095,"height":40},"line":67,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"50fc9b0f0aae46acb7cd2fa7c0253bb1","type":"text","conversion_output":false,"parent_id":"5ad299da43934b369338a9da67ac5c45","text":"This population includes all subjects who sign an Informed Consent Form, are","text_display":"This population includes all subjects who sign an Informed Consent Form, are","confidence":1,"confidence_rate":1},{"cnt":[[703,2283],[1827,2283],[1827,2326],[703,2326]],"region":{"top_left_x":702,"top_left_y":2282,"width":1125,"height":45},"line":68,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a7d9a142230846a09704395bae2d9ce6","type":"text","conversion_output":false,"parent_id":"5ad299da43934b369338a9da67ac5c45","text":"enrolled in the trial, are randomized, and receive a study device, but subjects are","text_display":" enrolled in the trial, are randomized, and receive a study device, but subjects are","confidence":1,"confidence_rate":1},{"cnt":[[703,2322],[1796,2322],[1796,2365],[703,2365]],"region":{"top_left_x":702,"top_left_y":2321,"width":1095,"height":45},"line":69,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b5996d7b686a4c6095ea4a5dce335c2c","type":"text","conversion_output":false,"parent_id":"5ad299da43934b369338a9da67ac5c45","text":"analyzed based on the treatment actually received. For example, if a subject is","text_display":" analyzed based on the treatment actually received. For example, if a subject is","confidence":1,"confidence_rate":1},{"cnt":[[703,2363],[1848,2363],[1848,2404],[703,2404]],"region":{"top_left_x":702,"top_left_y":2362,"width":1147,"height":43},"line":70,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5763da36c6cc41659aeb431d25951cdf","type":"text","conversion_output":false,"parent_id":"5ad299da43934b369338a9da67ac5c45","text":"assigned to receive a test device but instead receives a control device, that subject","text_display":" assigned to receive a test device but instead receives a control device, that subject","confidence":1,"confidence_rate":1},{"cnt":[[703,2402],[1727,2402],[1727,2447],[703,2447]],"region":{"top_left_x":702,"top_left_y":2401,"width":1026,"height":47},"line":71,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2137119fb3cf4c6f919b5d39e6501620","type":"text","conversion_output":false,"parent_id":"5ad299da43934b369338a9da67ac5c45","text":"will be considered a control subject for the as-treated analyses of implant","text_display":" will be considered a control subject for the as-treated analyses of implant","confidence":1,"confidence_rate":1},{"cnt":[[703,2441],[861,2441],[861,2482],[703,2482]],"region":{"top_left_x":702,"top_left_y":2440,"width":159,"height":43},"line":72,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"848564d34aa749a591fe0ee74b9bb3dc","type":"text","conversion_output":false,"parent_id":"5ad299da43934b369338a9da67ac5c45","text":"subgroups.","text_display":" subgroups.","confidence":1,"confidence_rate":1},{"cnt":[[103,2651],[312,2651],[312,2690],[103,2690]],"region":{"top_left_x":103,"top_left_y":2651,"width":209,"height":39},"line":73,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"95c7600138734d56bb54cd5c8c930b25","type":"page_info","conversion_output":false,"text":"Released","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[829,2655],[1291,2655],[1291,2690],[829,2690]],"region":{"top_left_x":829,"top_left_y":2655,"width":463,"height":35},"line":74,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3d83c024051341d4b38370e06a4bdf85","type":"page_info","conversion_output":false,"text":"REPRISE III Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1654,2651],[1983,2651],[1983,2688],[1654,2688]],"region":{"top_left_x":1654,"top_left_y":2651,"width":330,"height":37},"line":75,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3adcbaa43dfc421f865f3526145c0596","type":"page_info","conversion_output":false,"text":"90899936 AK. 4","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[486,2690],[2002,2690],[2002,2735],[486,2735]],"region":{"top_left_x":485,"top_left_y":2689,"width":1518,"height":46},"line":76,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"795e8770e99d46ab9195c35aa8240a1a","type":"page_info","conversion_output":false,"text":"Boston Scientific Confidential. 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Definitions","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[288,402],[1899,402],[1899,2486],[288,2486]],"region":{"top_left_x":287,"top_left_y":401,"width":1613,"height":2085},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4e47a50225b242e5beb057c51b718fb5","type":"table","conversion_output":true,"children_ids":["7035b70393e348b99fad6adb023ec2d9","d70d24c5ad07462d9a3c965870710bb0","e109a8a5b6cf4d48bd4b342bcfa130db","6c306713bc524e5b9c81084825713ec6","a6d0da7a31ce4ca083c5e4bd845e1fc2","48ba93687890480e8eb0f1b722ad9b65","4bca05fa617d458591a663e9af731a38","a3c5d48b7e3c40638970291ebdd51627","efef66e30d7147068b19480d3356cdef","993701c17ce041ebb695bde25c938d28","7f0d35f9286947e697c820abff3dd7f6","4b037d424f554d5e8a8262a90c57b826","6ae1c98adf9244e8841ecc3487373861","f514f8f2ab0a4d5aacd80c1a62be2896","9ebc6dcfeef74616b00c4a636f1c5608","0f3307dd9d7e42ff8aee2772d0d86ed5","f16af80411774ff2ade63cb70f107fc8","d7a0af6ce43c428a847c118d7d1dd9d1","d7f45666339b4964aa8ccd84b62b5dfa","e1c5ca1d39464f7ca8db101e23e4dfe3","a9db0662608f40f69bbdc3dede21e197","4464e8c2c2d24531bc287c10239aa3b8","f44c5938257c4ede8da7d51689aa6d90","505223662b1249718da9329ab1d19a04","fe2d79488ccb49fdaedf668303c54838","d6487dd663e749cd988a3a0edd3196e5","6d10b3245f1141bb82befe20359cc50e","b9c0ee0e1dc6442a8af18295b157145d","f893f1e9b4e84471820bbca765d66da1","b91aaa5584ad42588ceef75780e96cd9","021fe02b842c4a1bbf9658c5b944a575"],"selected_labels":["5c49e4f563c44e34ab4fd199aa43aa50"],"text":"\\begin{tabular}{|l|l|}\n\\hline Term & Definition \\\\\n\\hline & Note 1: If a subject receives 2 valves, the subject is assigned to the group corresponding to the first valve received. \\\\\n\\hline BLEEDING \\({ }^{72,73}\\) & \\begin{tabular}{l}\nLife-threatening or Disabling Bleeding \\\\\n- Fatal bleeding (Bleeding Academic Research Consortium [BARC] type \\(5^{124,125}\\) ) \\\\\n- Bleeding in a critical organ, such as intracranial, intraspinal, intraocular, or pericardial necessitating pericardiocentesis, or intramuscular with compartment syndrome (BARC type 3b and 3c) \\\\\n- Bleeding causing hypovolemic shock or severe hypotension requiring vasopressors or surgery (BARC type 3b) \\\\\n- Overt source of bleeding with drop in hemoglobin of \\(\\geq 5 g / dL\\) or whole blood or packed red blood cells (RBC) transfusion \\(\\geq 4\\) units (BARC type 3b)* \\\\\nMajor Bleeding (BARC type 3a) \\\\\n- Overt bleeding either associated with a drop in the hemoglobin level of at least \\(3.0 g / dL\\) or requiring transfusion of 2 or 3 units of whole blood/RBC, or causing hospitalization or permanent injury, or requiring surgery AND does not meet criteria of life-threatening or disabling bleeding \\\\\nMinor Bleeding (BARC type 2 or 3a, depending on the severity) \\\\\n- Any bleeding worthy of clinical mention (e.g., access site hematoma) that does not qualify as life-threatening, disabling, or major \\\\\n* Given one unit of packed RBC typically will raise blood hemoglobin concentration by \\(1 g / dL\\), an estimated decrease in hemoglobin will be calculated.\n\\end{tabular} \\\\\n\\hline CARDIAC DECOMPENSATION & Inability of the heart to maintain adequate circulation \\\\\n\\hline CARDIAC TAMPONADE & Evidence of a new pericardial effusion associated with hemodynamic instability and clearly related to the TAVR procedure. Clinical syndrome caused by the accumulation of fluid in the pericardial space, resulting in reduced ventricular filling and subsequent hemodynamic compromise. \\\\\n\\hline CARDIOGENIC SHOCK & An insufficient forward cardiac output to maintain adequate perfusion of vital organs to meet ongoing demands for oxygenation and metabolism. Cardiogenic shock is due to either inadequate left ventricular pump function (such as in congestive heart failure) or inadequate left ventricular filling (such as in cardiac tamponade). Cardiogenic shock is defined as sustained hypotension (>30 minutes) with evidence of tissue hypoperfusion including oliguria ( \\(<30 mL / h\\) ), cool extremities, cyanosis, and altered mental status. \\\\\n\\hline CEREBRAL INFARCTION & Evidence of brain cell death from imaging studies or pathological examination. If there are clinical symptoms, then it is a stroke; otherwise, it is an asymptomatic cerebral infarction. \\\\\n\\hline CHRONIC RENAL INSUFFICIENCY & Subject has chronic impairment of kidney function. \\\\\n\\hline CLINICAL PROCEDURAL SUCCESS (IN-HOSPITAL) & Implantation of the device in the absence of death, disabling stroke, major vascular complications, and life-threatening or major bleeding \\\\\n\\hline CONDUCTION DISTURBANCES \\({ }^{72,73}\\) & Implant-related new or worsened cardiac conduction disturbances include new or worsened first degree atrioventricular (AV) block, second degree AV block (Mobitz I or Mobitz II), third degree AV block, incomplete right bundle branch block (RBBB), RBBB, intraventricular conduction delay, left bundle branch block \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Table 26.2-1: Definitions}\n\\begin{tabular}{|l|l|}\n\\hline Term & Definition \\\\\n\\hline & Note 1: If a subject receives 2 valves, the subject is assigned to the group corresponding to the first valve received. \\\\\n\\hline BLEEDING \\({ }^{72,73}\\) & \\begin{tabular}{l}\nLife-threatening or Disabling Bleeding \\\\\n- Fatal bleeding (Bleeding Academic Research Consortium [BARC] type \\(5^{124,125}\\) ) \\\\\n- Bleeding in a critical organ, such as intracranial, intraspinal, intraocular, or pericardial necessitating pericardiocentesis, or intramuscular with compartment syndrome (BARC type 3b and 3c) \\\\\n- Bleeding causing hypovolemic shock or severe hypotension requiring vasopressors or surgery (BARC type 3b) \\\\\n- Overt source of bleeding with drop in hemoglobin of \\(\\geq 5 g / dL\\) or whole blood or packed red blood cells (RBC) transfusion \\(\\geq 4\\) units (BARC type 3b)* \\\\\nMajor Bleeding (BARC type 3a) \\\\\n- Overt bleeding either associated with a drop in the hemoglobin level of at least \\(3.0 g / dL\\) or requiring transfusion of 2 or 3 units of whole blood/RBC, or causing hospitalization or permanent injury, or requiring surgery AND does not meet criteria of life-threatening or disabling bleeding \\\\\nMinor Bleeding (BARC type 2 or 3a, depending on the severity) \\\\\n- Any bleeding worthy of clinical mention (e.g., access site hematoma) that does not qualify as life-threatening, disabling, or major \\\\\n* Given one unit of packed RBC typically will raise blood hemoglobin concentration by \\(1 g / dL\\), an estimated decrease in hemoglobin will be calculated.\n\\end{tabular} \\\\\n\\hline CARDIAC DECOMPENSATION & Inability of the heart to maintain adequate circulation \\\\\n\\hline CARDIAC TAMPONADE & Evidence of a new pericardial effusion associated with hemodynamic instability and clearly related to the TAVR procedure. Clinical syndrome caused by the accumulation of fluid in the pericardial space, resulting in reduced ventricular filling and subsequent hemodynamic compromise. \\\\\n\\hline CARDIOGENIC SHOCK & An insufficient forward cardiac output to maintain adequate perfusion of vital organs to meet ongoing demands for oxygenation and metabolism. Cardiogenic shock is due to either inadequate left ventricular pump function (such as in congestive heart failure) or inadequate left ventricular filling (such as in cardiac tamponade). Cardiogenic shock is defined as sustained hypotension (>30 minutes) with evidence of tissue hypoperfusion including oliguria ( \\(<30 mL / h\\) ), cool extremities, cyanosis, and altered mental status. \\\\\n\\hline CEREBRAL INFARCTION & Evidence of brain cell death from imaging studies or pathological examination. If there are clinical symptoms, then it is a stroke; otherwise, it is an asymptomatic cerebral infarction. \\\\\n\\hline CHRONIC RENAL INSUFFICIENCY & Subject has chronic impairment of kidney function. \\\\\n\\hline CLINICAL PROCEDURAL SUCCESS (IN-HOSPITAL) & Implantation of the device in the absence of death, disabling stroke, major vascular complications, and life-threatening or major bleeding \\\\\n\\hline CONDUCTION DISTURBANCES \\({ }^{72,73}\\) & Implant-related new or worsened cardiac conduction disturbances include new or worsened first degree atrioventricular (AV) block, second degree AV block (Mobitz I or Mobitz II), third degree AV block, incomplete right bundle branch block (RBBB), RBBB, intraventricular conduction delay, left bundle branch block \\\\\n\\hline\n\\end{tabular}\n\\end{table}","confidence":0.9697551727294922,"confidence_rate":0.9999981226448695},{"cnt":[[298,401],[642,401],[642,2486],[298,2486]],"region":{"top_left_x":297,"top_left_y":401,"width":346,"height":2086},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7035b70393e348b99fad6adb023ec2d9","type":"table_column","conversion_output":false,"parent_id":"4e47a50225b242e5beb057c51b718fb5","text":"","text_display":""},{"cnt":[[692,401],[1870,401],[1870,2486],[692,2486]],"region":{"top_left_x":691,"top_left_y":401,"width":1179,"height":2086},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d70d24c5ad07462d9a3c965870710bb0","type":"table_column","conversion_output":false,"parent_id":"4e47a50225b242e5beb057c51b718fb5","text":"","text_display":""},{"cnt":[[287,407],[1900,407],[1900,455],[287,455]],"region":{"top_left_x":287,"top_left_y":407,"width":1614,"height":49},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e109a8a5b6cf4d48bd4b342bcfa130db","type":"table_row","conversion_output":false,"parent_id":"4e47a50225b242e5beb057c51b718fb5","text":"","text_display":""},{"cnt":[[287,453],[1900,453],[1900,546],[287,546]],"region":{"top_left_x":287,"top_left_y":452,"width":1614,"height":95},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6c306713bc524e5b9c81084825713ec6","type":"table_row","conversion_output":false,"parent_id":"4e47a50225b242e5beb057c51b718fb5","text":"","text_display":""},{"cnt":[[287,535],[1900,535],[1900,1391],[287,1391]],"region":{"top_left_x":287,"top_left_y":535,"width":1614,"height":856},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a6d0da7a31ce4ca083c5e4bd845e1fc2","type":"table_row","conversion_output":false,"parent_id":"4e47a50225b242e5beb057c51b718fb5","text":"","text_display":""},{"cnt":[[287,1384],[1900,1384],[1900,1473],[287,1473]],"region":{"top_left_x":287,"top_left_y":1384,"width":1614,"height":89},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"48ba93687890480e8eb0f1b722ad9b65","type":"table_row","conversion_output":false,"parent_id":"4e47a50225b242e5beb057c51b718fb5","text":"","text_display":""},{"cnt":[[287,1471],[1900,1471],[1900,1646],[287,1646]],"region":{"top_left_x":287,"top_left_y":1470,"width":1614,"height":177},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4bca05fa617d458591a663e9af731a38","type":"table_row","conversion_output":false,"parent_id":"4e47a50225b242e5beb057c51b718fb5","text":"","text_display":""},{"cnt":[[287,1642],[1900,1640],[1901,1936],[287,1938]],"region":{"top_left_x":286,"top_left_y":1639,"width":1615,"height":300},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a3c5d48b7e3c40638970291ebdd51627","type":"table_row","conversion_output":false,"parent_id":"4e47a50225b242e5beb057c51b718fb5","text":"","text_display":""},{"cnt":[[287,1930],[1900,1930],[1900,2060],[287,2060]],"region":{"top_left_x":287,"top_left_y":1929,"width":1614,"height":131},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"efef66e30d7147068b19480d3356cdef","type":"table_row","conversion_output":false,"parent_id":"4e47a50225b242e5beb057c51b718fb5","text":"","text_display":""},{"cnt":[[287,2060],[1900,2060],[1900,2146],[287,2146]],"region":{"top_left_x":287,"top_left_y":2059,"width":1614,"height":88},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"993701c17ce041ebb695bde25c938d28","type":"table_row","conversion_output":false,"parent_id":"4e47a50225b242e5beb057c51b718fb5","text":"","text_display":""},{"cnt":[[287,2146],[1900,2146],[1900,2320],[287,2320]],"region":{"top_left_x":287,"top_left_y":2146,"width":1614,"height":174},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7f0d35f9286947e697c820abff3dd7f6","type":"table_row","conversion_output":false,"parent_id":"4e47a50225b242e5beb057c51b718fb5","text":"","text_display":""},{"cnt":[[287,2313],[1900,2313],[1900,2486],[287,2486]],"region":{"top_left_x":287,"top_left_y":2313,"width":1614,"height":174},"line":20,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4b037d424f554d5e8a8262a90c57b826","type":"table_row","conversion_output":false,"parent_id":"4e47a50225b242e5beb057c51b718fb5","text":"","text_display":""},{"cnt":[[309,414],[397,414],[397,446],[309,446]],"region":{"top_left_x":308,"top_left_y":413,"width":90,"height":34},"line":21,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6ae1c98adf9244e8841ecc3487373861","type":"simple_cell","conversion_output":false,"parent_id":"4e47a50225b242e5beb057c51b718fb5","text":"Term","text_display":"Term","cell_row":0,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[703,414],[857,414],[857,446],[703,446]],"region":{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1: If a subject receives 2 valves, the subject is assigned to the group corresponding to the first valve received.","text_display":"Note 1: If a subject receives 2 valves, the subject is assigned to the group corresponding to the first valve received.","cell_row":1,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[703,457],[1727,457],[1727,498],[703,498]],"region":{"top_left_x":702,"top_left_y":457,"width":1026,"height":42},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4ad90dfc1f9b444faad85a6e328df692","type":"text","conversion_output":false,"parent_id":"9ebc6dcfeef74616b00c4a636f1c5608","text":"Note 1: If a subject receives 2 valves, the subject is assigned to the group","text_display":"Note 1: If a subject receives 2 valves, the subject is assigned to the group","confidence":1,"confidence_rate":1},{"cnt":[[703,501],[1277,501],[1277,542],[703,542]],"region":{"top_left_x":702,"top_left_y":500,"width":575,"height":42},"line":25,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a73b01194e40435780c1b9fac77da669","type":"text","conversion_output":false,"parent_id":"9ebc6dcfeef74616b00c4a636f1c5608","text":"corresponding to the first valve received.","text_display":" corresponding to the first valve received.","confidence":1,"confidence_rate":1},{"cnt":[[309,540],[540,540],[540,581],[309,581]],"region":{"top_left_x":308,"top_left_y":539,"width":233,"height":42},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0f3307dd9d7e42ff8aee2772d0d86ed5","type":"simple_cell","conversion_output":false,"parent_id":"4e47a50225b242e5beb057c51b718fb5","text":"BLEEDING \\({ }^{72,73}\\)","text_display":"BLEEDING \\({ }^{72,73}\\)","cell_row":2,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[698,544],[1861,544],[1861,1386],[698,1386]],"region":{"top_left_x":698,"top_left_y":543,"width":1164,"height":844},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f16af80411774ff2ade63cb70f107fc8","type":"complex_cell","conversion_output":false,"parent_id":"4e47a50225b242e5beb057c51b718fb5","children_ids":["bc53c2e1db6547cd9024a61bf18b0f51","163d89c3be1b405eb0d5837f9834579e","bfd9822452854aacacd0758dd4b833a0","7f644c2725e5408fbfbe7a7f018d665c","188d9e4e3a9243508e017eed1f0ab262","ee0165da792448ec89942f9e664dfd31","7b8a486e589648bb8bbcd75e92363d85","0d47284c0f3740b1be03ceeedee7877c","94adefaec706448db1c072ef0a22c9fd","aa0d7ff895b946f38a969c0bb5f415b1","c2340550fe6542759fdba0dd428bbb6a","7e1d29749a8244c7bfedd533656dd203","f2ce35a913f042b9b5d857d0098873c9","bd25ec95807f434d8b6703144e563437","09a347e82d8440e2a4ddaad4d843170d","2b931dc983784c0ab970372df0780673","2a57d5d673e54a62a76dabf601e8c454","478150be06dd4d64a8e969e0ce79afcb","992e2997b11e4fbb95a0db00d6d5ed1d"],"text":"\\begin{tabular}{l}\nLife-threatening or Disabling Bleeding \\\\\n- Fatal bleeding (Bleeding Academic Research Consortium [BARC] type \\(5^{124,125}\\) ) \\\\\n- Bleeding in a critical organ, such as intracranial, intraspinal, intraocular, or pericardial necessitating pericardiocentesis, or intramuscular with compartment syndrome (BARC type 3b and 3c) \\\\\n- Bleeding causing hypovolemic shock or severe hypotension requiring vasopressors or surgery (BARC type 3b) \\\\\n- Overt source of bleeding with drop in hemoglobin of \\(\\geq 5 g / dL\\) or whole blood or packed red blood cells (RBC) transfusion \\(\\geq 4\\) units (BARC type 3b)* \\\\\nMajor Bleeding (BARC type 3a) \\\\\n- Overt bleeding either associated with a drop in the hemoglobin level of at least \\(3.0 g / dL\\) or requiring transfusion of 2 or 3 units of whole blood/RBC, or causing hospitalization or permanent injury, or requiring surgery AND does not meet criteria of life-threatening or disabling bleeding \\\\\nMinor Bleeding (BARC type 2 or 3a, depending on the severity) \\\\\n- Any bleeding worthy of clinical mention (e.g., access site hematoma) that does not qualify as life-threatening, disabling, or major \\\\\n* Given one unit of packed RBC typically will raise blood hemoglobin concentration by \\(1 g / dL\\), an estimated decrease in hemoglobin will be calculated.\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nLife-threatening or Disabling Bleeding \\\\\n- Fatal bleeding (Bleeding Academic Research Consortium [BARC] type \\(5^{124,125}\\) ) \\\\\n- Bleeding in a critical organ, such as intracranial, intraspinal, intraocular, or pericardial necessitating pericardiocentesis, or intramuscular with compartment syndrome (BARC type 3b and 3c) \\\\\n- Bleeding causing hypovolemic shock or severe hypotension requiring vasopressors or surgery (BARC type 3b) \\\\\n- Overt source of bleeding with drop in hemoglobin of \\(\\geq 5 g / dL\\) or whole blood or packed red blood cells (RBC) transfusion \\(\\geq 4\\) units (BARC type 3b)* \\\\\nMajor Bleeding (BARC type 3a) \\\\\n- Overt bleeding either associated with a drop in the hemoglobin level of at least \\(3.0 g / dL\\) or requiring transfusion of 2 or 3 units of whole blood/RBC, or causing hospitalization or permanent injury, or requiring surgery AND does not meet criteria of life-threatening or disabling bleeding \\\\\nMinor Bleeding (BARC type 2 or 3a, depending on the severity) \\\\\n- Any bleeding worthy of clinical mention (e.g., access site hematoma) that does not qualify as life-threatening, disabling, or major \\\\\n* Given one unit of packed RBC typically will raise blood hemoglobin concentration by \\(1 g / dL\\), an estimated decrease in hemoglobin will be 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circulation","cell_row":3,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[306,1479],[538,1479],[538,1560],[306,1560]],"region":{"top_left_x":306,"top_left_y":1479,"width":233,"height":81},"line":51,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e1c5ca1d39464f7ca8db101e23e4dfe3","type":"complex_cell","conversion_output":false,"parent_id":"4e47a50225b242e5beb057c51b718fb5","children_ids":["5f008c7be0d7469ca1a61e53053523ad","f484607740c14e9db1b236fdfb0ce86a"],"text":"CARDIAC TAMPONADE","text_display":"CARDIAC 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Clinical syndrome caused by the accumulation of fluid in the pericardial space, resulting in reduced ventricular filling and subsequent hemodynamic compromise.","text_display":"Evidence of a new pericardial effusion associated with hemodynamic instability and clearly related to the TAVR procedure. Clinical syndrome caused by the accumulation of fluid in the pericardial space, resulting in reduced ventricular filling and subsequent hemodynamic compromise.","cell_row":4,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.99951171875,"confidence_rate":0.9999984544299978},{"cnt":[[703,1479],[1822,1479],[1822,1521],[703,1521]],"region":{"top_left_x":702,"top_left_y":1479,"width":1121,"height":42},"line":55,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5a460e395f724f018d96c3d0758475f2","type":"text","conversion_output":false,"parent_id":"a9db0662608f40f69bbdc3dede21e197","text":"Evidence of a new pericardial effusion associated with hemodynamic instability","text_display":"Evidence of a new pericardial effusion associated with hemodynamic instability","confidence":1,"confidence_rate":1},{"cnt":[[703,1521],[1775,1521],[1775,1564],[703,1564]],"region":{"top_left_x":702,"top_left_y":1520,"width":1073,"height":44},"line":56,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6d4d4f2cc1ae45f9ba680f2845b859eb","type":"text","conversion_output":false,"parent_id":"a9db0662608f40f69bbdc3dede21e197","text":"and clearly related to the TAVR procedure. Clinical syndrome caused by the","text_display":" and clearly related to the TAVR procedure. Clinical syndrome caused by the","confidence":0.99951171875,"confidence_rate":0.999993817734324},{"cnt":[[703,1560],[1792,1560],[1792,1603],[703,1603]],"region":{"top_left_x":702,"top_left_y":1559,"width":1091,"height":44},"line":57,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b8471040c7244aaf8e154f85f3cc5123","type":"text","conversion_output":false,"parent_id":"a9db0662608f40f69bbdc3dede21e197","text":"accumulation of fluid in the pericardial space, resulting in reduced ventricular","text_display":" accumulation of fluid in the pericardial space, resulting in reduced ventricular","confidence":1,"confidence_rate":1},{"cnt":[[703,1601],[1409,1601],[1409,1642],[703,1642]],"region":{"top_left_x":702,"top_left_y":1600,"width":707,"height":42},"line":58,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"30c9e6c2645b4dbca8f833e1afb1a86f","type":"text","conversion_output":false,"parent_id":"a9db0662608f40f69bbdc3dede21e197","text":"filling and subsequent hemodynamic compromise.","text_display":" filling and subsequent hemodynamic compromise.","confidence":1,"confidence_rate":1},{"cnt":[[306,1648],[558,1648],[558,1728],[306,1728]],"region":{"top_left_x":306,"top_left_y":1648,"width":252,"height":81},"line":59,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4464e8c2c2d24531bc287c10239aa3b8","type":"complex_cell","conversion_output":false,"parent_id":"4e47a50225b242e5beb057c51b718fb5","children_ids":["835d0b6512314a9281f54bb4f8a67e1b","6dabd7995ca341efa7666ca9b4f76c6e"],"text":"CARDIOGENIC SHOCK","text_display":"CARDIOGENIC SHOCK","cell_row":5,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[309,1650],[556,1650],[556,1685],[309,1685]],"region":{"top_left_x":308,"top_left_y":1650,"width":248,"height":36},"line":60,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"835d0b6512314a9281f54bb4f8a67e1b","type":"text","conversion_output":false,"parent_id":"4464e8c2c2d24531bc287c10239aa3b8","text":"CARDIOGENIC","text_display":"CARDIOGENIC","confidence":1,"confidence_rate":1},{"cnt":[[309,1692],[432,1692],[432,1724],[309,1724]],"region":{"top_left_x":308,"top_left_y":1691,"width":125,"height":34},"line":61,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6dabd7995ca341efa7666ca9b4f76c6e","type":"text","conversion_output":false,"parent_id":"4464e8c2c2d24531bc287c10239aa3b8","text":"SHOCK","text_display":" SHOCK","confidence":1,"confidence_rate":1},{"cnt":[[698,1644],[1857,1644],[1857,1932],[698,1932]],"region":{"top_left_x":698,"top_left_y":1643,"width":1159,"height":290},"line":62,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f44c5938257c4ede8da7d51689aa6d90","type":"complex_cell","conversion_output":false,"parent_id":"4e47a50225b242e5beb057c51b718fb5","children_ids":["3a259937d2c54a8c8d84dc3bfdbce519","aafb27eceb58495e8abb4f1318379d59","278bd91372b447eaa93b2f0b41fc838e","f0c9bef462f3457cab8904ad12efcf80","bbcf062deb23401dafb3c4f67a0d55ed","5df0dfb414a544789be09c54734e7318","bb66342019b64f96adfe863e6ccd1241"],"text":"An insufficient forward cardiac output to maintain adequate perfusion of vital organs to meet ongoing demands for oxygenation and metabolism. Cardiogenic shock is due to either inadequate left ventricular pump function (such as in congestive heart failure) or inadequate left ventricular filling (such as in cardiac tamponade). Cardiogenic shock is defined as sustained hypotension (>30 minutes) with evidence of tissue hypoperfusion including oliguria ( \\(<30 mL / h\\) ), cool extremities, cyanosis, and altered mental status.","text_display":"An insufficient forward cardiac output to maintain adequate perfusion of vital organs to meet ongoing demands for oxygenation and metabolism. Cardiogenic shock is due to either inadequate left ventricular pump function (such as in congestive heart failure) or inadequate left ventricular filling (such as in cardiac tamponade). 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Cardiogenic shock is defined as sustained hypotension (>30 minutes)","text_display":" tamponade). 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Possible mechanisms for mechanical coronary obstruction include the following. \\\\\n- Impingement of the coronary ostia by the valve support structure in the setting of suboptimal valve positioning and/or 'small aortic root' anatomy \\\\\n- Embolization from calcium, thrombus, air, or endocarditis displacement of native aortic valve leaflets towards the coronary ostia during TAVR \\\\\n- Suture-related kinking or obstruction or cannulation related obstruction of the coronary ostia associated with surgical AVR \\\\\nThe diagnosis of TAVR-associated coronary obstruction can be determined by imaging studies (coronary angiography, intravascular ultrasound, multi-slice CT angiography, or echocardiography), surgical exploration, or autopsy findings. Cardiac biomarker elevations and ECG changes indicating new ischemia provide corroborative evidence.\n\\end{tabular} \\\\\n\\hline DEATH & \\begin{tabular}{l}\nAll-cause Death \\\\\nDeath from any cause after a valve intervention. \\\\\nCardiovascular Death \\\\\nAny one of the following criteria is met. \\\\\n- Any death due to proximate cardiac cause (e.g., myocardial infarction, cardiac tamponade, worsening heart failure) \\\\\n- Sudden or unwitnessed death \\\\\n- Death of unknown cause \\\\\n- Death caused by noncoronary vascular conditions such as neurological events, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular disease \\\\\n- All procedure-related deaths, including those related to a complication of the procedure or treatment for a complication of the procedure \\\\\n- All valve-related deaths including structural or nonstructural valve dysfunction or other valve-related adverse events \\\\\nNon-cardiovascular Death \\\\\n- Any death in which the primary cause of death is clearly related to another condition (e.g. trauma, cancer, suicide)\n\\end{tabular} \\\\\n\\hline \\begin{tabular}{l}\nDEVICE DEFICIENCY \\\\\nRef: ISO 14155:2011 \\\\\nRef:MEDDEV 2.7/3 \\\\\n12/2010\n\\end{tabular} & \\begin{tabular}{l}\ninadequacy of a medical device with respect to its identity, quality, durability, reliability, safety or performance. \\\\\nNote 1: Device deficiencies include malfunctions, use errors, and inadequate labeling.\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Table 26.2-1: Definitions}\n\\begin{tabular}{|l|l|}\n\\hline Term & Definition \\\\\n\\hline & \\begin{tabular}{l}\n(LBBB), left anterior fascicular block, or left posterior fascicular block, including block requiring permanent pacemaker implant \\\\\nNote 1: High grade AV block is considered persistent if it is present every time the underlying rhythm is checked. \\\\\nNote 2: See also definitions for arrhythmia and permanent pacemaker.\n\\end{tabular} \\\\\n\\hline CONVERSION TO OPEN SURGERY & Conversion to open sternotomy during the TAVR procedure secondary to any procedure-related complications \\\\\n\\hline CORONARY OBSTRUCTION & \\begin{tabular}{l}\nAngiographic or echocardiographic evidence of a new, partial or complete, obstruction of a coronary ostium, either by the valve prosthesis itself, the native leaflets, calcifications, or dissection, occurring during or after the TAVR procedure. \\\\\nMechanical coronary artery obstruction following TAVR or surgical AVR that typically occurs during the index procedure. Possible mechanisms for mechanical coronary obstruction include the following. \\\\\n- Impingement of the coronary ostia by the valve support structure in the setting of suboptimal valve positioning and/or 'small aortic root' anatomy \\\\\n- Embolization from calcium, thrombus, air, or endocarditis displacement of native aortic valve leaflets towards the coronary ostia during TAVR \\\\\n- Suture-related kinking or obstruction or cannulation related obstruction of the coronary ostia associated with surgical AVR \\\\\nThe diagnosis of TAVR-associated coronary obstruction can be determined by imaging studies (coronary angiography, intravascular ultrasound, multi-slice CT angiography, or echocardiography), surgical exploration, or autopsy findings. 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OBSTRUCTION","cell_row":3,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[309,765],[506,765],[506,795],[309,795]],"region":{"top_left_x":308,"top_left_y":764,"width":198,"height":32},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"088942eab05b4c7fb3c6404cca548955","type":"text","conversion_output":false,"parent_id":"aac2e52fd0cc4921bdf039e68a2370e6","text":"CORONARY","text_display":"CORONARY","confidence":1,"confidence_rate":1},{"cnt":[[313,804],[560,804],[560,836],[313,836]],"region":{"top_left_x":312,"top_left_y":803,"width":248,"height":34},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d17f91f798a74417b21c74cbbe17e599","type":"text","conversion_output":false,"parent_id":"aac2e52fd0cc4921bdf039e68a2370e6","text":"OBSTRUCTION","text_display":" OBSTRUCTION","confidence":1,"confidence_rate":1},{"cnt":[[698,760],[1879,760],[1879,1508],[698,1508]],"region":{"top_left_x":698,"top_left_y":760,"width":1181,"height":748},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b6a5da01a2e44eb582816935650da407","type":"complex_cell","conversion_output":false,"parent_id":"cccbc06875ee49bd87cc6835bc667ab8","children_ids":["f3636d81c007460aa9287ac8f825f84a","cce81174d71b4ae4aee5e317c275add3","27f6d00634a74af892ef6c5442341432","c87944b8384b47ba98800b79a339f69b","5c5b7347faf9453d93d921a61fb96a66","26227678323c4829932310a82d92d782","92d7f3c7564b4e2d906353e02015a072","84298dc8b8514d918fa084dd56300b94","7dbb70367b4447068ff46f1fa6649cc0","dae77f000fd345e3a0d41011602e7024","f342c6349a6347138581f8f8cdfcd37a","63a5f0ff04ea4ec192c28061e4a2cff2","4728f84e9698472699e50383506f4dc0","fd9ddc319e8c4715bba1ee2d15ad9158","748732a7698746798144cbd968413b1a","75d1bc6d788a466db3931e897488a864","241fb17cd5824e70bec6e921fa7fb3b4"],"text":"\\begin{tabular}{l}\nAngiographic or echocardiographic evidence of a new, partial or complete, obstruction of a coronary ostium, either by the valve prosthesis itself, the native leaflets, calcifications, or dissection, occurring during or after the TAVR procedure. \\\\\nMechanical coronary artery obstruction following TAVR or surgical AVR that typically occurs during the index procedure. Possible mechanisms for mechanical coronary obstruction include the following. \\\\\n- Impingement of the coronary ostia by the valve support structure in the setting of suboptimal valve positioning and/or 'small aortic root' anatomy \\\\\n- Embolization from calcium, thrombus, air, or endocarditis displacement of native aortic valve leaflets towards the coronary ostia during TAVR \\\\\n- Suture-related kinking or obstruction or cannulation related obstruction of the coronary ostia associated with surgical AVR \\\\\nThe diagnosis of TAVR-associated coronary obstruction can be determined by imaging studies (coronary angiography, intravascular ultrasound, multi-slice CT angiography, or echocardiography), surgical exploration, or autopsy findings. Cardiac biomarker elevations and ECG changes indicating new ischemia provide corroborative evidence.\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nAngiographic or echocardiographic evidence of a new, partial or complete, obstruction of a coronary ostium, either by the valve prosthesis itself, the native leaflets, calcifications, or dissection, occurring during or after the TAVR procedure. \\\\\nMechanical coronary artery obstruction following TAVR or surgical AVR that typically occurs during the index procedure. Possible mechanisms for mechanical coronary obstruction include the following. \\\\\n- Impingement of the coronary ostia by the valve support structure in the setting of suboptimal valve positioning and/or 'small aortic root' anatomy \\\\\n- Embolization from calcium, thrombus, air, or endocarditis displacement of native aortic valve leaflets towards the coronary ostia during TAVR \\\\\n- Suture-related kinking or obstruction or cannulation related obstruction of the coronary ostia associated with surgical AVR \\\\\nThe diagnosis of TAVR-associated coronary obstruction can be determined by imaging studies (coronary angiography, intravascular ultrasound, multi-slice CT angiography, or echocardiography), surgical exploration, or autopsy findings. Cardiac biomarker elevations and ECG changes indicating new ischemia provide corroborative evidence.\n\\end{tabular}","cell_row":3,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.99951171875,"confidence_rate":0.9999996735291321},{"cnt":[[705,765],[1749,765],[1749,802],[705,802]],"region":{"top_left_x":704,"top_left_y":764,"width":1045,"height":38},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f3636d81c007460aa9287ac8f825f84a","type":"text","conversion_output":false,"parent_id":"b6a5da01a2e44eb582816935650da407","text":"Angiographic or echocardiographic evidence of a new, partial or complete,","text_display":"Angiographic or echocardiographic evidence of a new, partial or complete,","confidence":1,"confidence_rate":1},{"cnt":[[707,804],[1818,804],[1818,841],[707,841]],"region":{"top_left_x":707,"top_left_y":803,"width":1112,"height":38},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"cce81174d71b4ae4aee5e317c275add3","type":"text","conversion_output":false,"parent_id":"b6a5da01a2e44eb582816935650da407","text":"obstruction of a coronary ostium, either by the valve prosthesis itself, the native","text_display":" obstruction of a coronary ostium, either by the valve prosthesis itself, the native","confidence":0.99951171875,"confidence_rate":0.999994450009741},{"cnt":[[707,843],[1874,843],[1874,884],[707,884]],"region":{"top_left_x":707,"top_left_y":842,"width":1168,"height":42},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"27f6d00634a74af892ef6c5442341432","type":"text","conversion_output":false,"parent_id":"b6a5da01a2e44eb582816935650da407","text":"leaflets, calcifications, or dissection, occurring during or after the TAVR procedure.","text_display":" leaflets, calcifications, or dissection, occurring during or after the TAVR procedure.","confidence":1,"confidence_rate":1},{"cnt":[[703,929],[1803,929],[1803,968],[703,968]],"region":{"top_left_x":702,"top_left_y":929,"width":1101,"height":40},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c87944b8384b47ba98800b79a339f69b","type":"text","conversion_output":false,"parent_id":"b6a5da01a2e44eb582816935650da407","text":"Mechanical coronary artery obstruction following TAVR or surgical AVR that","text_display":"\nMechanical coronary artery obstruction following TAVR or surgical AVR that","confidence":1,"confidence_rate":1},{"cnt":[[707,968],[1844,968],[1844,1010],[707,1010]],"region":{"top_left_x":707,"top_left_y":968,"width":1137,"height":42},"line":39,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5c5b7347faf9453d93d921a61fb96a66","type":"text","conversion_output":false,"parent_id":"b6a5da01a2e44eb582816935650da407","text":"typically occurs during the index procedure. Possible mechanisms for mechanical","text_display":" typically occurs during the index procedure. Possible mechanisms for mechanical","confidence":1,"confidence_rate":1},{"cnt":[[707,1012],[1311,1012],[1311,1048],[707,1048]],"region":{"top_left_x":707,"top_left_y":1011,"width":605,"height":38},"line":40,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"26227678323c4829932310a82d92d782","type":"text","conversion_output":false,"parent_id":"b6a5da01a2e44eb582816935650da407","text":"coronary obstruction include the following.","text_display":" coronary obstruction include the following.","confidence":1,"confidence_rate":1},{"cnt":[[705,1055],[1876,1055],[1876,1096],[705,1096]],"region":{"top_left_x":704,"top_left_y":1054,"width":1173,"height":43},"line":41,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"92d7f3c7564b4e2d906353e02015a072","type":"text","conversion_output":false,"parent_id":"b6a5da01a2e44eb582816935650da407","text":"- Impingement of the coronary ostia by the valve support structure in the setting of","text_display":"\n- Impingement of the coronary ostia by the valve support structure in the setting of","confidence":1,"confidence_rate":1},{"cnt":[[742,1098],[1634,1098],[1634,1135],[742,1135]],"region":{"top_left_x":741,"top_left_y":1098,"width":893,"height":38},"line":42,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"84298dc8b8514d918fa084dd56300b94","type":"text","conversion_output":false,"parent_id":"b6a5da01a2e44eb582816935650da407","text":"suboptimal valve positioning and/or 'small aortic root' anatomy","text_display":" suboptimal valve positioning and/or 'small aortic root' anatomy","confidence":1,"confidence_rate":1},{"cnt":[[705,1142],[1788,1142],[1788,1183],[705,1183]],"region":{"top_left_x":704,"top_left_y":1141,"width":1084,"height":42},"line":43,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7dbb70367b4447068ff46f1fa6649cc0","type":"text","conversion_output":false,"parent_id":"b6a5da01a2e44eb582816935650da407","text":"- Embolization from calcium, thrombus, air, or endocarditis displacement of","text_display":"\n- Embolization from calcium, thrombus, air, or endocarditis displacement of","confidence":1,"confidence_rate":1},{"cnt":[[742,1183],[1692,1183],[1692,1222],[742,1222]],"region":{"top_left_x":741,"top_left_y":1182,"width":952,"height":40},"line":44,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"dae77f000fd345e3a0d41011602e7024","type":"text","conversion_output":false,"parent_id":"b6a5da01a2e44eb582816935650da407","text":"native aortic valve leaflets towards the coronary ostia during TAVR","text_display":" native aortic valve leaflets towards the coronary ostia during TAVR","confidence":1,"confidence_rate":1},{"cnt":[[705,1228],[1824,1228],[1824,1269],[705,1269]],"region":{"top_left_x":704,"top_left_y":1228,"width":1121,"height":42},"line":45,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f342c6349a6347138581f8f8cdfcd37a","type":"text","conversion_output":false,"parent_id":"b6a5da01a2e44eb582816935650da407","text":"- Suture-related kinking or obstruction or cannulation related obstruction of the","text_display":"\n- Suture-related kinking or obstruction or cannulation related obstruction of the","confidence":1,"confidence_rate":1},{"cnt":[[742,1267],[1368,1267],[1368,1308],[742,1308]],"region":{"top_left_x":741,"top_left_y":1267,"width":627,"height":42},"line":46,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"63a5f0ff04ea4ec192c28061e4a2cff2","type":"text","conversion_output":false,"parent_id":"b6a5da01a2e44eb582816935650da407","text":"coronary ostia associated with surgical AVR","text_display":" coronary ostia associated with surgical AVR","confidence":1,"confidence_rate":1},{"cnt":[[705,1311],[1801,1311],[1801,1352],[705,1352]],"region":{"top_left_x":704,"top_left_y":1310,"width":1097,"height":42},"line":47,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4728f84e9698472699e50383506f4dc0","type":"text","conversion_output":false,"parent_id":"b6a5da01a2e44eb582816935650da407","text":"The diagnosis of TAVR-associated coronary obstruction can be determined by","text_display":"\nThe diagnosis of TAVR-associated coronary obstruction can be determined by","confidence":1,"confidence_rate":1},{"cnt":[[705,1349],[1824,1349],[1824,1391],[705,1391]],"region":{"top_left_x":704,"top_left_y":1349,"width":1121,"height":42},"line":48,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"fd9ddc319e8c4715bba1ee2d15ad9158","type":"text","conversion_output":false,"parent_id":"b6a5da01a2e44eb582816935650da407","text":"imaging studies (coronary angiography, intravascular ultrasound, multi-slice CT","text_display":" imaging studies (coronary angiography, intravascular ultrasound, multi-slice CT","confidence":1,"confidence_rate":1},{"cnt":[[703,1391],[1783,1391],[1783,1430],[703,1430]],"region":{"top_left_x":702,"top_left_y":1390,"width":1082,"height":40},"line":49,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"748732a7698746798144cbd968413b1a","type":"text","conversion_output":false,"parent_id":"b6a5da01a2e44eb582816935650da407","text":"angiography, or echocardiography), surgical exploration, or autopsy findings.","text_display":" angiography, or echocardiography), surgical exploration, or autopsy findings.","confidence":1,"confidence_rate":1},{"cnt":[[705,1432],[1835,1432],[1835,1469],[705,1469]],"region":{"top_left_x":704,"top_left_y":1431,"width":1132,"height":38},"line":50,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"75d1bc6d788a466db3931e897488a864","type":"text","conversion_output":false,"parent_id":"b6a5da01a2e44eb582816935650da407","text":"Cardiac biomarker elevations and ECG changes indicating new ischemia provide","text_display":" Cardiac biomarker elevations and ECG changes indicating new ischemia provide","confidence":1,"confidence_rate":1},{"cnt":[[703,1471],[1034,1471],[1034,1503],[703,1503]],"region":{"top_left_x":702,"top_left_y":1470,"width":333,"height":34},"line":51,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"241fb17cd5824e70bec6e921fa7fb3b4","type":"text","conversion_output":false,"parent_id":"b6a5da01a2e44eb582816935650da407","text":"corroborative evidence.","text_display":" corroborative evidence.","confidence":1,"confidence_rate":1},{"cnt":[[309,1518],[432,1518],[432,1551],[309,1551]],"region":{"top_left_x":308,"top_left_y":1518,"width":125,"height":33},"line":52,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0afcee3d34c24907b2768f4282a108d3","type":"simple_cell","conversion_output":false,"parent_id":"cccbc06875ee49bd87cc6835bc667ab8","text":"DEATH","text_display":"DEATH","cell_row":4,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[698,1516],[1848,1516],[1848,2296],[698,2296]],"region":{"top_left_x":698,"top_left_y":1516,"width":1151,"height":780},"line":53,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"377c075177814cc1b4ac9f6ad9fd98a6","type":"complex_cell","conversion_output":false,"parent_id":"cccbc06875ee49bd87cc6835bc667ab8","children_ids":["8ebc6c69e51e4e5aa3d7e3f1c0a9dc61","cabb56df30534472aa3e99c39f9d518b","9327ee97750a4674b50f0561915f7e94","afdca3551db64de491187ba187e87b62","1af63fd0184d4a92815f12d709ebf5e8","c01af7bcb20445b0b0369bf02a8c2957","cbc4d8250cd6449382a66e8ade25efd3","d6191e08e0aa487596ac3e964c6fab95","f0e01250539340c59a6c98a3899e0a58","0916d37470164620be2aa52e6c60cc36","8e4b2b531816468796acd77f645e5f45","cf5ad88cd76742b3ad1859e0d8c4fe5c","a1a03f232e684ab4915a1755c2c08ac3","32598bc20e5c4f23b47cb8c50bda139f","59bad2f0b3e549f8a1b8799ca14ade8b","cd1cecf2739b4aa0b4e7d24c2cd4c4a1","ba2513a5ee1f49e1a776786d2d5fb47d","369dde4fd85b4de7ab83b1b26d2d986c"],"text":"\\begin{tabular}{l}\nAll-cause Death \\\\\nDeath from any cause after a valve intervention. \\\\\nCardiovascular Death \\\\\nAny one of the following criteria is met. \\\\\n- Any death due to proximate cardiac cause (e.g., myocardial infarction, cardiac tamponade, worsening heart failure) \\\\\n- Sudden or unwitnessed death \\\\\n- Death of unknown cause \\\\\n- Death caused by noncoronary vascular conditions such as neurological events, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular disease \\\\\n- All procedure-related deaths, including those related to a complication of the procedure or treatment for a complication of the procedure \\\\\n- All valve-related deaths including structural or nonstructural valve dysfunction or other valve-related adverse events \\\\\nNon-cardiovascular Death \\\\\n- Any death in which the primary cause of death is clearly related to another condition (e.g. trauma, cancer, suicide)\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nAll-cause Death \\\\\nDeath from any cause after a valve intervention. \\\\\nCardiovascular Death \\\\\nAny one of the following criteria is met. \\\\\n- Any death due to proximate cardiac cause (e.g., myocardial infarction, cardiac tamponade, worsening heart failure) \\\\\n- Sudden or unwitnessed death \\\\\n- Death of unknown cause \\\\\n- Death caused by noncoronary vascular conditions such as neurological events, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular disease \\\\\n- All procedure-related deaths, including those related to a complication of the procedure or treatment for a complication of the procedure \\\\\n- All valve-related deaths including structural or nonstructural valve dysfunction or other valve-related adverse events \\\\\nNon-cardiovascular Death \\\\\n- Any death in which the primary cause of death is clearly related to another condition (e.g. trauma, cancer, suicide)\n\\end{tabular}","cell_row":4,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[703,1518],[934,1518],[934,1555],[703,1555]],"region":{"top_left_x":702,"top_left_y":1518,"width":233,"height":38},"line":54,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8ebc6c69e51e4e5aa3d7e3f1c0a9dc61","type":"text","conversion_output":false,"parent_id":"377c075177814cc1b4ac9f6ad9fd98a6","text":"All-cause Death","text_display":"All-cause Death","confidence":1,"confidence_rate":1},{"cnt":[[703,1564],[1376,1564],[1376,1603],[703,1603]],"region":{"top_left_x":702,"top_left_y":1563,"width":675,"height":40},"line":55,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"cabb56df30534472aa3e99c39f9d518b","type":"text","conversion_output":false,"parent_id":"377c075177814cc1b4ac9f6ad9fd98a6","text":"Death from any cause after a valve intervention.","text_display":"\nDeath from any cause after a valve intervention.","confidence":1,"confidence_rate":1},{"cnt":[[703,1605],[1012,1605],[1012,1642],[703,1642]],"region":{"top_left_x":702,"top_left_y":1605,"width":311,"height":37},"line":56,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9327ee97750a4674b50f0561915f7e94","type":"text","conversion_output":false,"parent_id":"377c075177814cc1b4ac9f6ad9fd98a6","text":"Cardiovascular Death","text_display":"\nCardiovascular Death","confidence":1,"confidence_rate":1},{"cnt":[[703,1648],[1268,1648],[1268,1689],[703,1689]],"region":{"top_left_x":702,"top_left_y":1648,"width":566,"height":42},"line":57,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"afdca3551db64de491187ba187e87b62","type":"text","conversion_output":false,"parent_id":"377c075177814cc1b4ac9f6ad9fd98a6","text":"Any one of the following criteria is met.","text_display":"\nAny one of the following criteria is met.","confidence":1,"confidence_rate":1},{"cnt":[[703,1696],[1835,1696],[1835,1737],[703,1737]],"region":{"top_left_x":702,"top_left_y":1695,"width":1134,"height":43},"line":58,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1af63fd0184d4a92815f12d709ebf5e8","type":"text","conversion_output":false,"parent_id":"377c075177814cc1b4ac9f6ad9fd98a6","text":"- Any death due to proximate cardiac cause (e.g., myocardial infarction, cardiac","text_display":"\n- Any death due to proximate cardiac cause (e.g., myocardial infarction, cardiac","confidence":1,"confidence_rate":1},{"cnt":[[742,1735],[1248,1735],[1248,1776],[742,1776]],"region":{"top_left_x":741,"top_left_y":1734,"width":508,"height":43},"line":59,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c01af7bcb20445b0b0369bf02a8c2957","type":"text","conversion_output":false,"parent_id":"377c075177814cc1b4ac9f6ad9fd98a6","text":"tamponade, worsening heart failure)","text_display":" tamponade, 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device with respect to its identity, quality, durability, reliability, safety or performance. \\\\\nNote 1: Device deficiencies include malfunctions, use errors, and inadequate labeling.\n\\end{tabular}","text_display":"\\begin{tabular}{l}\ninadequacy of a medical device with respect to its identity, quality, durability, reliability, safety or performance. \\\\\nNote 1: Device deficiencies include malfunctions, use errors, and inadequate labeling.\n\\end{tabular}","cell_row":5,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.99755859375,"confidence_rate":0.9999847226708135},{"cnt":[[703,2302],[1790,2302],[1790,2343],[703,2343]],"region":{"top_left_x":702,"top_left_y":2302,"width":1088,"height":42},"line":78,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"33fd901d0cbd4150b7ff0bc2b3a85ac9","type":"text","conversion_output":false,"parent_id":"ec495898e3ac4981afabf6d9eb61a36e","text":"inadequacy of a medical device with respect to its identity, 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This can be confirmed by X-ray, echocardiography, CT scan or MRI or valve migration demonstrated by direct assessment during open heart surgery or at autopsy. \\\\\n\\hline DEVICE RELATED COMPLICATIONS & Complications associated with the device as it relates to delivery, placement, efficacy or durability; these may involve the implanted device or the delivery system. \\\\\n\\hline ECTOPIC VALVE DEPLOYMENT & Permanent deployment of the valve prosthesis in a location other than the aortic root. \\\\\n\\hline EMBOLISM & Examples include a free flowing blood clot or lesion material that is located in the systemic or pulmonary circulation. Embolism may be manifested by a neurological event or a noncerebral embolic event. \\\\\n\\hline ENCEPHALOPATHY & Altered mental state (e.g., seizures, delirium, confusion, hallucinations, dementia, coma, psychiatric episode, etc.) \\\\\n\\hline ENDOCARDITIS & \\begin{tabular}{l}\nInfective endocarditis is diagnosed based on Duke criteria \\({ }^{126}\\) and necessitates the following. \\\\\n- Two major criteria -OR- \\\\\n- One major and three minor criteria -OR- \\\\\n- Five minor criteria \\\\\nMajor Criteria \\\\\n- Positive blood culture for infective endocarditis \\\\\n- Typical microorganism consistent with infective endocarditis from 2 separate blood cultures, as noted below. \\\\\n- Viridans streptococci, Streptococcus bovis, or HACEK group (Haemophilus [Haemophilus parainfluenzae, Haemophilus aphrophilus, and Haemophilus paraphrophilus], Actinobacillus actinomycetemcomitans [Aggregatibacter actinomycetemcomitans], Cardiobacterium hominis, Eikenella corrodens, Kingella kingae -OR- \\\\\n- Community-acquired Staphylococcus aureus or enterococci, in the absence of a primary focus \\\\\n-OR- \\\\\n- Microorganisms consistent with infective endocarditis from persistently positive blood cultures defined as noted below. \\\\\n- Two ( 2 ) positive cultures of blood samples drawn >12 hours apart -OR- \\\\\n- All of 3 or a majority of 4 separate cultures of blood (with first and last sample drawn 1 hour apart) \\\\\n- Evidence of endocardial involvement \\\\\n- Positive echocardiogram for infective endocarditis defined as noted below. \\\\\n- Oscillating intracardiac mass on valve or supporting structures, in the path of regurgitant jets, or on implanted material in the absence of an alternative anatomic explanation -OR- \\\\\n- Abscess -OR- \\\\\n- New partial dehiscence of prosthetic valve \\\\\n-OR-\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Table 26.2-1: Definitions}\n\\begin{tabular}{|l|l|}\n\\hline Term & Definition \\\\\n\\hline DEVICE FAILURE & A device failure is identified whenever the criteria for device success are not met. \\\\\n\\hline DEVICE MIGRATION & Device migration is defined as an upward or downward displacement of the implanted valve from its original implant location, after initial correct positioning within the aortic annulus from its initial position, with or without consequences. This can be confirmed by X-ray, echocardiography, CT scan or MRI or valve migration demonstrated by direct assessment during open heart surgery or at autopsy. \\\\\n\\hline DEVICE RELATED COMPLICATIONS & Complications associated with the device as it relates to delivery, placement, efficacy or durability; these may involve the implanted device or the delivery system. \\\\\n\\hline ECTOPIC VALVE DEPLOYMENT & Permanent deployment of the valve prosthesis in a location other than the aortic root. \\\\\n\\hline EMBOLISM & Examples include a free flowing blood clot or lesion material that is located in the systemic or pulmonary circulation. Embolism may be manifested by a neurological event or a noncerebral embolic event. \\\\\n\\hline ENCEPHALOPATHY & Altered mental state (e.g., seizures, delirium, confusion, hallucinations, dementia, coma, psychiatric episode, etc.) \\\\\n\\hline ENDOCARDITIS & \\begin{tabular}{l}\nInfective endocarditis is diagnosed based on Duke criteria \\({ }^{126}\\) and necessitates the following. \\\\\n- Two major criteria -OR- \\\\\n- One major and three minor criteria -OR- \\\\\n- Five minor criteria \\\\\nMajor Criteria \\\\\n- Positive blood culture for infective endocarditis \\\\\n- Typical microorganism consistent with infective endocarditis from 2 separate blood cultures, as noted below. \\\\\n- Viridans streptococci, Streptococcus bovis, or HACEK group (Haemophilus [Haemophilus parainfluenzae, Haemophilus aphrophilus, and Haemophilus paraphrophilus], Actinobacillus actinomycetemcomitans [Aggregatibacter actinomycetemcomitans], Cardiobacterium hominis, Eikenella corrodens, Kingella kingae -OR- \\\\\n- Community-acquired Staphylococcus aureus or enterococci, in the absence of a primary focus \\\\\n-OR- \\\\\n- Microorganisms consistent with infective endocarditis from persistently positive blood cultures defined as noted below. \\\\\n- Two ( 2 ) positive cultures of blood samples drawn >12 hours apart -OR- \\\\\n- All of 3 or a majority of 4 separate cultures of blood (with first and last sample drawn 1 hour apart) \\\\\n- Evidence of endocardial involvement \\\\\n- Positive echocardiogram for infective endocarditis defined as noted below. \\\\\n- Oscillating intracardiac mass on valve or supporting structures, in the path of regurgitant jets, or on implanted material in the absence of an alternative anatomic explanation -OR- \\\\\n- Abscess -OR- \\\\\n- New partial dehiscence of prosthetic valve \\\\\n-OR-\n\\end{tabular} 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endocarditis is diagnosed based on Duke criteria \\({ }^{126}\\) and necessitates the following. \\\\\n- Two major criteria -OR- \\\\\n- One major and three minor criteria -OR- \\\\\n- Five minor criteria \\\\\nMajor Criteria \\\\\n- Positive blood culture for infective endocarditis \\\\\n- Typical microorganism consistent with infective endocarditis from 2 separate blood cultures, as noted below. \\\\\n- Viridans streptococci, Streptococcus bovis, or HACEK group (Haemophilus [Haemophilus parainfluenzae, Haemophilus aphrophilus, and Haemophilus paraphrophilus], Actinobacillus actinomycetemcomitans [Aggregatibacter actinomycetemcomitans], Cardiobacterium hominis, Eikenella corrodens, Kingella kingae -OR- \\\\\n- Community-acquired Staphylococcus aureus or enterococci, in the absence of a primary focus \\\\\n-OR- \\\\\n- Microorganisms consistent with infective endocarditis from persistently positive blood cultures defined as noted below. \\\\\n- Two ( 2 ) positive cultures of blood samples drawn >12 hours apart -OR- \\\\\n- All of 3 or a majority of 4 separate cultures of blood (with first and last sample drawn 1 hour apart) \\\\\n- Evidence of endocardial involvement \\\\\n- Positive echocardiogram for infective endocarditis defined as noted below. \\\\\n- Oscillating intracardiac mass on valve or supporting structures, in the path of regurgitant jets, or on implanted material in the absence of an alternative anatomic explanation -OR- \\\\\n- Abscess -OR- \\\\\n- New partial dehiscence of prosthetic valve \\\\\n-OR-\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nInfective endocarditis is diagnosed based on Duke criteria \\({ }^{126}\\) and necessitates the following. \\\\\n- Two major criteria -OR- \\\\\n- One major and three minor criteria -OR- \\\\\n- Five minor criteria \\\\\nMajor Criteria \\\\\n- Positive blood culture for infective endocarditis \\\\\n- Typical microorganism consistent with infective endocarditis from 2 separate blood cultures, as noted below. \\\\\n- Viridans streptococci, Streptococcus bovis, or HACEK group (Haemophilus [Haemophilus parainfluenzae, Haemophilus aphrophilus, and Haemophilus paraphrophilus], Actinobacillus actinomycetemcomitans [Aggregatibacter actinomycetemcomitans], Cardiobacterium hominis, Eikenella corrodens, Kingella kingae -OR- \\\\\n- Community-acquired Staphylococcus aureus or enterococci, in the absence of a primary focus \\\\\n-OR- \\\\\n- Microorganisms consistent with infective endocarditis from persistently positive blood cultures defined as noted below. \\\\\n- Two ( 2 ) positive cultures of blood samples drawn >12 hours apart -OR- \\\\\n- All of 3 or a majority of 4 separate cultures of blood (with first and last sample drawn 1 hour apart) \\\\\n- Evidence of endocardial involvement \\\\\n- Positive echocardiogram for infective endocarditis defined as noted below. \\\\\n- Oscillating intracardiac mass on valve or supporting structures, in the path of regurgitant jets, or on 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Term & Definition \\\\\n\\hline & \\begin{tabular}{l}\n- New valvular regurgitation (worsening or changing of preexisting murmur not sufficient) \\\\\nMinor Criteria \\\\\n- Predisposition: predisposing heart condition or intravenous drug use \\\\\n- Fever: temperature \\(>38.0^{\\circ} C \\left(100.4^{\\circ} F \\right)\\) \\\\\n- Vascular phenomena: major arterial emboli, septic pulmonary infarcts, mycotic aneurysm, intracranial hemorrhage, conjunctival hemorrhages, and Janeway lesions \\\\\n- Immunologic phenomena: glomerulonephritis, Osler's nodes, Roth spots, and rheumatoid factor \\\\\n- Microbiological evidence: positive blood culture but does not meet a major criterion as noted above or serological evidence of active infection with organism consistent with infective endocarditis \\\\\n- Echocardiographic findings: consistent with infective endocarditis but do not meet a major criterion as noted above \\\\\nImplanted valve endocarditis includes any infection involving an implanted valve. The diagnosis of operated valvular endocarditis is based on one of the following criteria. \\\\\n- Fulfillment of the Duke endocarditis criteria as defined above \\\\\n- Evidence of abscess, paravalvular leak, pus, or vegetation confirmed as secondary to infection by histological or bacteriologic studies during a reoperation \\\\\n- Findings of abscess, pus, or vegetation involving a repaired or replaced valve during an autopsy.\n\\end{tabular} \\\\\n\\hline EXPLANT & Removal of the investigational valve implant for any reason. \\\\\n\\hline FRAILTY & Slowness, weakness, exhaustion, wasting and malnutrition, poor endurance and inactivity, loss of independence. \\\\\n\\hline HEMOLYSIS & Two plasma free hemoglobin values \\(>40 mg / dL\\) with the two readings taken within a single 48-hour period. If the second plasma free hemoglobin assessment is not performed within 48 hours following an initial determination of \\(>40 mg / dL\\), this would qualify as an AE. \\\\\n\\hline HOSTILE CHEST & \\begin{tabular}{l}\nAny of the following or other reasons that make redo operation through sternotomy or right anterior thoracotomy prohibitively hazardous: \\\\\n- Abnormal chest wall anatomy due to severe kyphoscoliosis or other skeletal abnormalities (including thoracoplasty, Potts' disease) \\\\\n- Complications from prior surgery \\\\\n- Evidence of severe radiation damage (e.g. skin burns, bone destruction, muscle loss, lung fibrosis or esophageal stricture) \\\\\n- History of multiple recurrent pleural effusions causing internal adhesions\n\\end{tabular} \\\\\n\\hline IMPLANTED ANALYSIS SET & \\begin{tabular}{l}\nThis population includes all subjects who sign an Informed Consent Form, are enrolled in the trial, and are implanted with the assigned, randomized study device. \\\\\nNote 1: If a subject receives 2 valves, the subject is assigned to the group corresponding to the first valve received.\n\\end{tabular} \\\\\n\\hline INTENT TO TREAT (ITT) ANALYSIS SET & \\begin{tabular}{l}\nThis population includes all subjects who sign an Informed Consent Form, are enrolled in the trial, and are randomized, whether or not an assigned study device is implanted. Subjects in the ITT population will be followed with their ITT cohort. \\\\\nNote 1: If a subject receives 2 valves, the subject is assigned to the group\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Table 26.2-1: Definitions}\n\\begin{tabular}{|l|l|}\n\\hline Term & Definition \\\\\n\\hline & \\begin{tabular}{l}\n- New valvular regurgitation (worsening or changing of preexisting murmur not sufficient) \\\\\nMinor Criteria \\\\\n- Predisposition: predisposing heart condition or intravenous drug use \\\\\n- Fever: temperature \\(>38.0^{\\circ} C \\left(100.4^{\\circ} F \\right)\\) \\\\\n- Vascular phenomena: major arterial emboli, septic pulmonary infarcts, mycotic aneurysm, intracranial hemorrhage, conjunctival hemorrhages, and Janeway lesions \\\\\n- Immunologic phenomena: glomerulonephritis, Osler's nodes, Roth spots, and rheumatoid factor \\\\\n- Microbiological evidence: positive blood culture but does not meet a major criterion as noted above or serological evidence of active infection with organism consistent with infective endocarditis \\\\\n- Echocardiographic findings: consistent with infective endocarditis but do not meet a major criterion as noted above \\\\\nImplanted valve endocarditis includes any infection involving an implanted valve. The diagnosis of operated valvular endocarditis is based on one of the following criteria. \\\\\n- Fulfillment of the Duke endocarditis criteria as defined above \\\\\n- Evidence of abscess, paravalvular leak, pus, or vegetation confirmed as secondary to infection by histological or bacteriologic studies during a reoperation \\\\\n- Findings of abscess, pus, or vegetation involving a repaired or replaced valve during an autopsy.\n\\end{tabular} \\\\\n\\hline EXPLANT & Removal of the investigational valve implant for any reason. \\\\\n\\hline FRAILTY & Slowness, weakness, exhaustion, wasting and malnutrition, poor endurance and inactivity, loss of independence. \\\\\n\\hline HEMOLYSIS & Two plasma free hemoglobin values \\(>40 mg / dL\\) with the two readings taken within a single 48-hour period. If the second plasma free hemoglobin assessment is not performed within 48 hours following an initial determination of \\(>40 mg / dL\\), this would qualify as an AE. \\\\\n\\hline HOSTILE CHEST & \\begin{tabular}{l}\nAny of the following or other reasons that make redo operation through sternotomy or right anterior thoracotomy prohibitively hazardous: \\\\\n- Abnormal chest wall anatomy due to severe kyphoscoliosis or other skeletal abnormalities (including thoracoplasty, Potts' disease) \\\\\n- Complications from prior surgery \\\\\n- Evidence of severe radiation damage (e.g. skin burns, bone destruction, muscle loss, lung fibrosis or esophageal stricture) \\\\\n- History of multiple recurrent pleural effusions causing internal adhesions\n\\end{tabular} \\\\\n\\hline IMPLANTED ANALYSIS SET & \\begin{tabular}{l}\nThis population includes all subjects who sign an Informed Consent Form, are enrolled in the trial, and are implanted with the assigned, randomized study device. \\\\\nNote 1: If a subject receives 2 valves, the subject is assigned to the group corresponding to the first valve received.\n\\end{tabular} \\\\\n\\hline INTENT TO TREAT (ITT) ANALYSIS SET & \\begin{tabular}{l}\nThis population includes all subjects who sign an Informed Consent Form, are enrolled in the trial, and are randomized, whether or not an assigned study device is implanted. Subjects in the ITT population will be followed with their ITT cohort. \\\\\nNote 1: If a subject receives 2 valves, the subject is assigned to the group\n\\end{tabular} 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A patient may be considered extreme risk if any of the following are present: \\\\\n- The conduit(s) are radiographically indistinguishable from the posterior table of the sternum. \\\\\n- The conduit(s) are radiographically distinguishable from the posterior table of the sternum but lie within \\(2-3 mm\\) of the posterior table.\n\\end{tabular} \\\\\n\\hline INTRACRANIAL HEMORRHAGE & Collection of blood between the brain and skull; subcategorized as epidural, subdural, and subarachnoid bleeds. \\\\\n\\hline LEFT BUNDLE BRANCH BLOCK (LBBB) & \\begin{tabular}{l}\nThe appearance of typical complete LBBB in the three KEY leads (I, V1, and V6) with the following diagnostic criteria [see Figure below]. \\\\\n- The heart rhythm must be supraventricular in origin \\\\\n- QRS widening to at least 0.12 sec \\\\\n- An upright (monophasic) QRS complex in leads I and V6; the QRS may be notched, but there should not be any q wave in either lead I or lead V6. \\\\\n- A predominantly negative QRS complex in lead V1; there may or may not be an initial small r wave in lead V 1 , that is, lead V1 may show either a QS or RS complex.![](https://cdn.mathpix.com/cropped/40f68f98-216b-48da-9b91-d6ee4b323748-129.jpg?height=406\\&width=720\\&top_left_y=1345\\&top_left_x=776)\n\\end{tabular} \\\\\n\\hline LIVER DISEASE (SEVERE) /CIRRHOSIS & \\begin{tabular}{l}\nAny of the following: \\\\\n- Child-Pugh class C \\\\\n- MELD score \\(\\geq 10\\) \\\\\n- Portal-caval, spleno-renal, or transjugular intrahepatic portal shunt \\\\\n- Biopsy proven cirrhosis with portal hypertension or hepatocellular dysfunction\n\\end{tabular} \\\\\n\\hline MITRAL VALVE APPARATUS DAMAGE & Angiographic or echocardiographic evidence of a new damage to the mitral valve apparatus (chordae papillary muscle, or leaflet) during or after the TAVR procedure. \\\\\n\\hline MODIFIED DEVICE SUCCESS & Absence of mortality with the originally implanted transcatheter valve in the proper anatomical location, no additional aortic valve procedures, and with the intended performance of the prosthetic valve (either a mean aortic valve gradient \\(<20 mm\\) Hg or a peak velocity \\(<3 m / sec\\) with no moderate or severe prosthetic valve aortic regurgitation) \\\\\n\\hline MYOCARDIAL INFARCTION (MI) & \\begin{tabular}{l}\nPeriprocedural MI ( \\(\\leq 7 2\\) hours after the index procedure) \\\\\n- New ischemic symptoms (e.g., chest pain or shortness of breath) or new\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Table 26.2-1: Definitions}\n\\begin{tabular}{|l|l|}\n\\hline Term & Definition \\\\\n\\hline & corresponding to the first valve received. \\\\\n\\hline INTERNAL MAMMARY ARTERY OR OTHER CRITICAL CONDUIT(S) CROSSING MIDLINE AND/OR ADHERENT TO POSTERIOR TABLE OF STERNUM & \\begin{tabular}{l}\nA patent IMA graft that is adherent to the sternum such that injuring it during reoperation is likely. A patient may be considered extreme risk if any of the following are present: \\\\\n- The conduit(s) are radiographically indistinguishable from the posterior table of the sternum. \\\\\n- The conduit(s) are radiographically distinguishable from the posterior table of the sternum but lie within \\(2-3 mm\\) of the posterior table.\n\\end{tabular} \\\\\n\\hline INTRACRANIAL HEMORRHAGE & Collection of blood between the brain and skull; subcategorized as epidural, subdural, and subarachnoid bleeds. \\\\\n\\hline LEFT BUNDLE BRANCH BLOCK (LBBB) & \\begin{tabular}{l}\nThe appearance of typical complete LBBB in the three KEY leads (I, V1, and V6) with the following diagnostic criteria [see Figure below]. \\\\\n- The heart rhythm must be supraventricular in origin \\\\\n- QRS widening to at least 0.12 sec \\\\\n- An upright (monophasic) QRS complex in leads I and V6; the QRS may be notched, but there should not be any q wave in either lead I or lead V6. \\\\\n- A predominantly negative QRS complex in lead V1; there may or may not be an initial small r wave in lead V 1 , that is, lead V1 may show either a QS or RS complex.![](https://cdn.mathpix.com/cropped/40f68f98-216b-48da-9b91-d6ee4b323748-129.jpg?height=406\\&width=720\\&top_left_y=1345\\&top_left_x=776)\n\\end{tabular} \\\\\n\\hline LIVER DISEASE (SEVERE) /CIRRHOSIS & \\begin{tabular}{l}\nAny of the following: \\\\\n- Child-Pugh class C \\\\\n- MELD score \\(\\geq 10\\) \\\\\n- Portal-caval, spleno-renal, or transjugular intrahepatic portal shunt \\\\\n- Biopsy proven cirrhosis with portal hypertension or hepatocellular dysfunction\n\\end{tabular} \\\\\n\\hline MITRAL VALVE APPARATUS DAMAGE & Angiographic or echocardiographic evidence of a new damage to the mitral valve apparatus (chordae papillary muscle, or leaflet) during or after the TAVR procedure. \\\\\n\\hline MODIFIED DEVICE SUCCESS & Absence of mortality with the originally implanted transcatheter valve in the proper anatomical location, no additional 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A patient may be considered extreme risk if any of the following are present: \\\\\n- The conduit(s) are radiographically indistinguishable from the posterior table of the sternum. \\\\\n- The conduit(s) are radiographically distinguishable from the posterior table of the sternum but lie within \\(2-3 mm\\) of the posterior table.\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nA patent IMA graft that is adherent to the sternum such that injuring it during reoperation is likely. A patient may be considered extreme risk if any of the following are present: \\\\\n- The conduit(s) are radiographically indistinguishable from the posterior table of the sternum. \\\\\n- The conduit(s) are radiographically distinguishable from the posterior table of the sternum but lie within \\(2-3 mm\\) of the posterior table.\n\\end{tabular}","cell_row":2,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[703,509],[1786,509],[1786,548],[703,548]],"region":{"top_left_x":702,"top_left_y":509,"width":1084,"height":40},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"38e9b596fc9046a5bd06effad4bb3248","type":"text","conversion_output":false,"parent_id":"ecd308520e5346fca982c11ff33797ad","text":"A patent IMA graft that is adherent to the sternum such that injuring it during","text_display":"A patent IMA graft that is adherent to the sternum such that injuring it during","confidence":1,"confidence_rate":1},{"cnt":[[703,548],[1762,548],[1762,587],[703,587]],"region":{"top_left_x":702,"top_left_y":548,"width":1060,"height":40},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f29c4e04f192459b90c71289fa8f386f","type":"text","conversion_output":false,"parent_id":"ecd308520e5346fca982c11ff33797ad","text":"reoperation is likely. A patient may be considered extreme risk if any of the","text_display":" reoperation is likely. A patient may be considered extreme risk if any of the","confidence":1,"confidence_rate":1},{"cnt":[[703,587],[1012,587],[1012,628],[703,628]],"region":{"top_left_x":702,"top_left_y":587,"width":311,"height":42},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"48deca6ed11e486ea9878b63d01cfded","type":"text","conversion_output":false,"parent_id":"ecd308520e5346fca982c11ff33797ad","text":"following are present:","text_display":" following are present:","confidence":1,"confidence_rate":1},{"cnt":[[703,633],[1861,633],[1861,674],[703,674]],"region":{"top_left_x":702,"top_left_y":632,"width":1160,"height":42},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"696cc58d30b74e158b007522acfd75b0","type":"text","conversion_output":false,"parent_id":"ecd308520e5346fca982c11ff33797ad","text":"- The conduit(s) are radiographically indistinguishable from the posterior table of","text_display":"\n- The conduit(s) are radiographically 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bleeds.","cell_row":3,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[703,836],[1766,836],[1766,875],[703,875]],"region":{"top_left_x":702,"top_left_y":836,"width":1065,"height":40},"line":44,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b9942183186f41849be8a0371a5fabb3","type":"text","conversion_output":false,"parent_id":"3c915212311d4de682bb5e7871f1f454","text":"Collection of blood between the brain and skull; subcategorized as epidural,","text_display":"Collection of blood between the brain and skull; subcategorized as epidural,","confidence":1,"confidence_rate":1},{"cnt":[[703,877],[1194,877],[1194,914],[703,914]],"region":{"top_left_x":702,"top_left_y":877,"width":493,"height":38},"line":45,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1470847dfba84c328e52e06bda8c70e4","type":"text","conversion_output":false,"parent_id":"3c915212311d4de682bb5e7871f1f454","text":"subdural, and subarachnoid bleeds.","text_display":" subdural, and subarachnoid bleeds.","confidence":1,"confidence_rate":1},{"cnt":[[306,923],[588,923],[588,1048],[306,1048]],"region":{"top_left_x":306,"top_left_y":922,"width":283,"height":127},"line":46,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"99952c398f314f0f8f376edf59d68cbd","type":"complex_cell","conversion_output":false,"parent_id":"a39fe0af3d6b4c3c8c3e23baba3f6cdf","children_ids":["607d3e6a417d4a5b886ff2997ccad14c","82442380c6f14abb95f5eccc964c1f74","2139b083b33044bd9c6f373fc91062f4"],"text":"LEFT BUNDLE BRANCH BLOCK (LBBB)","text_display":"LEFT BUNDLE BRANCH BLOCK (LBBB)","cell_row":4,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[309,925],[549,925],[549,958],[309,958]],"region":{"top_left_x":308,"top_left_y":925,"width":242,"height":33},"line":47,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"607d3e6a417d4a5b886ff2997ccad14c","type":"text","conversion_output":false,"parent_id":"99952c398f314f0f8f376edf59d68cbd","text":"LEFT BUNDLE","text_display":"LEFT BUNDLE","confidence":1,"confidence_rate":1},{"cnt":[[309,964],[588,964],[588,999],[309,999]],"region":{"top_left_x":308,"top_left_y":964,"width":281,"height":35},"line":48,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"82442380c6f14abb95f5eccc964c1f74","type":"text","conversion_output":false,"parent_id":"99952c398f314f0f8f376edf59d68cbd","text":"BRANCH BLOCK","text_display":" BRANCH 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least 0.12 sec \\\\\n- An upright (monophasic) QRS complex in leads I and V6; the QRS may be notched, but there should not be any q wave in either lead I or lead V6. \\\\\n- A predominantly negative QRS complex in lead V1; there may or may not be an initial small r wave in lead V 1 , that is, lead V1 may show either a QS or RS complex.![](https://cdn.mathpix.com/cropped/40f68f98-216b-48da-9b91-d6ee4b323748-129.jpg?height=406\\&width=720\\&top_left_y=1345\\&top_left_x=776)\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nThe appearance of typical complete LBBB in the three KEY leads (I, V1, and V6) with the following diagnostic criteria [see Figure below]. \\\\\n- The heart rhythm must be supraventricular in origin \\\\\n- QRS widening to at least 0.12 sec \\\\\n- An upright (monophasic) QRS complex in leads I and V6; the QRS may be notched, but there should not be any q wave in either lead I or lead V6. \\\\\n- A predominantly negative QRS complex in lead V1; there may or may not be an initial small r wave in lead V 1 , that is, lead V1 may show either a QS or RS complex.![](https://cdn.mathpix.com/cropped/40f68f98-216b-48da-9b91-d6ee4b323748-129.jpg?height=406\\&width=720\\&top_left_y=1345\\&top_left_x=776)\n\\end{tabular}","cell_row":4,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.9052424486769723,"confidence_rate":0.9998496865391643},{"cnt":[[703,925],[1850,925],[1850,966],[703,966]],"region":{"top_left_x":702,"top_left_y":925,"width":1149,"height":42},"line":51,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8eb1437125514a57a8eaa27e9e0ad110","type":"text","conversion_output":false,"parent_id":"b04f454351634784a56e4df299327703","text":"The appearance of typical complete LBBB in the three KEY leads (I, V1, and V6)","text_display":"The appearance of typical complete LBBB in the three KEY leads (I, V1, and V6)","confidence":1,"confidence_rate":1},{"cnt":[[703,964],[1502,964],[1502,1005],[703,1005]],"region":{"top_left_x":702,"top_left_y":964,"width":800,"height":42},"line":52,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5b370debaf7c4198b0e5e9232a07cab3","type":"text","conversion_output":false,"parent_id":"b04f454351634784a56e4df299327703","text":"with the following diagnostic criteria [see Figure below].","text_display":" with the following diagnostic criteria [see Figure below].","confidence":1,"confidence_rate":1},{"cnt":[[703,1012],[1467,1012],[1467,1053],[703,1053]],"region":{"top_left_x":702,"top_left_y":1011,"width":766,"height":42},"line":53,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"414c031f99b44420b84f5e771f42fe62","type":"text","conversion_output":false,"parent_id":"b04f454351634784a56e4df299327703","text":"- The heart rhythm must be supraventricular in origin","text_display":"\n- The heart rhythm must be 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If cardiac biomarkers are increased at baseline (>99th percentile), a further increase of at least \\(50 \\%\\) post-procedure is required AND the peak value must exceed the previously stated limit. \\\\\nSpontaneous MI (>72 hours after the index procedure) \\\\\nAny one of the following criteria applies. \\\\\n- Detection of rise and/or fall of cardiac biomarkers (preferably troponin) with at least one value above the \\(99^{\\text {th }}\\) percentile URL, together with evidence of myocardial ischemia with at least one of the following \\\\\n- Symptoms of ischemia \\\\\n- ECG changes indicative of new ischemia [new ST-T changes or new LBBB] \\\\\n- New pathological Q waves in at least two contiguous leads \\\\\n- Imaging evidence of new loss of viable myocardium or new wall motion abnormality \\\\\n- Sudden, unexpected cardiac death, involving cardiac arrest, often with symptoms suggestive of myocardial ischemia, and accompanied by presumably new STsegment elevation, or new LBBB, and/or evidence of fresh thrombus by coronary angiography and/ or at autopsy, but death occurring before blood samples could be obtained, or at a time before the appearance of cardiac biomarkers in the blood. \\\\\n- Pathological findings of an acute myocardial infarction \\({ }^{127}\\).\n\\end{tabular} \\\\\n\\hline NEUROLOGICAL EVENT & Any central, new neurological deficit, whether temporary or permanent and whether focal or global, that occurs after the subject emerges from anesthesia \\\\\n\\hline NEW YORK HEART ASSOCIATION CLASSIFICATION (NYHA) & Classification system for defining cardiac disease and related functional limitations into four broad categorizations:\n![](https://cdn.mathpix.com/cropped/40f68f98-216b-48da-9b91-d6ee4b323748-130.jpg?height=573\\&width=1177\\&top_left_y=1845\\&top_left_x=702) \\\\\n\\hline NONSTRUCTURAL & Any abnormality not intrinsic to the valve itself that results in stenosis or \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Table 26.2-1: Definitions}\n\\begin{tabular}{|l|l|}\n\\hline Term & Definition \\\\\n\\hline & \\begin{tabular}{l}\nischemic signs (e.g., ventricular arrhythmias, new or worsening heart failure, new ST-segment changes, hemodynamic instability, new pathological Q waves in at least two contiguous leads, or imaging evidence of new loss of viable myocardium or new wall motion abnormality) \\\\\n-AND- \\\\\n- Elevated cardiac biomarkers (preferably CK-MB) within 72 h after the index procedure, consisting of at least one sample post-procedure with a peak value exceeding \\(15 \\times\\) upper reference limit (troponin) or \\(5 \\times\\) for CK-MB. If cardiac biomarkers are increased at baseline (>99th percentile), a further increase of at least \\(50 \\%\\) post-procedure is required AND the peak value must exceed the previously stated limit. \\\\\nSpontaneous MI (>72 hours after the index procedure) \\\\\nAny one of the following criteria applies. \\\\\n- Detection of rise and/or fall of cardiac biomarkers (preferably troponin) with at least one value above the \\(99^{\\text {th }}\\) percentile URL, together with evidence of myocardial ischemia with at least one of the following \\\\\n- Symptoms of ischemia \\\\\n- ECG changes indicative of new ischemia [new ST-T changes or new LBBB] \\\\\n- New pathological Q waves in at least two contiguous leads \\\\\n- Imaging evidence of new loss of viable myocardium or new wall motion abnormality \\\\\n- Sudden, unexpected cardiac death, involving cardiac arrest, often with symptoms suggestive of myocardial ischemia, and accompanied by presumably new STsegment elevation, or new LBBB, and/or evidence of fresh thrombus by coronary angiography and/ or at autopsy, but death occurring before blood samples could be obtained, or at a time before the appearance of cardiac biomarkers in the blood. \\\\\n- Pathological findings of an acute myocardial infarction \\({ }^{127}\\).\n\\end{tabular} \\\\\n\\hline NEUROLOGICAL EVENT & Any central, new neurological deficit, whether temporary or permanent and whether focal or global, that occurs after the subject emerges from anesthesia \\\\\n\\hline NEW YORK HEART ASSOCIATION CLASSIFICATION (NYHA) & Classification system for defining cardiac disease and related functional limitations into four broad categorizations:\n![](https://cdn.mathpix.com/cropped/40f68f98-216b-48da-9b91-d6ee4b323748-130.jpg?height=573\\&width=1177\\&top_left_y=1845\\&top_left_x=702) \\\\\n\\hline NONSTRUCTURAL & Any abnormality not intrinsic to the valve itself that results in stenosis or 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The term nonstructural dysfunction refers to problems (exclusive of thrombosis and infection) that do not directly involve valve components yet result in dysfunction of an operated valve, as diagnosed by re-operation, autopsy, or clinical investigation. Nonstructural dysfunction includes the following. \\\\\n- Entrapment by pannus, tissue, or suture \\\\\n- Paravalvular leak \\\\\n- Inappropriate sizing or positioning \\\\\n- Residual leak or obstruction after valve implantation or repair \\\\\n- Clinically important intravascular hemolytic anemia \\\\\n- Development of aortic or pulmonic regurgitation as a result of technical errors \\\\\n- Dilatation of the sinotubular junction \\\\\n- Dilatation of the valve annulus after either valve replacement with stentless prostheses, new onset of coronary ischemia from coronary ostial obstruction, or paravalvular aortic regurgitation\n\\end{tabular} \\\\\n\\hline OPERATIVE RISK & \\begin{tabular}{l}\nOperative risk is determined by a center cardiac surgeon and must be confirmed by the Case Review Committee (including a cardiac surgeon). \\\\\nExtreme Risk: Predicted operative mortality or serious, irreversible morbidity risk \\(\\geq 50 \\%\\) at 30 days \\\\\nHigh Risk: Predicted operative mortality or serious, irreversible morbidity risk \\(\\geq 15 \\%\\) at 30 days\n\\end{tabular} \\\\\n\\hline PARAVALVULAR REGURGITATION & Leakage due to a separation of the prosthetic valve from the annulus. Any evidence of leakage of blood around the device. Diagnosis of paravalvular regurgitation may be obtained from TEE/TTE, however, definitive diagnosis is obtained at reoperation, explant, or autopsy. \\\\\n\\hline PERMANENT PACEMAKER (PPM) IMPLANTATION \\({ }^{114}\\) & \\begin{tabular}{l}\nImplantation of new PPM after the index procedure resulting from new or worsened conduction disturbances \\\\\n- Procedure-related: PPM is implanted in subjects with new onset or worsened conduction disturbances occurring post index procedure \\\\\n- Not related to procedure: PPM is implanted in subjects with known conduction disturbances that did not advance after the index procedure. \\\\\nNote 1: See also definitions for arrhythmia and conductance disturbance.\n\\end{tabular} \\\\\n\\hline PORCELAIN AORTA & Heavy circumferential calcification of the entire ascending aorta extending to the arch such that aortic cross-clamping is not feasible \\\\\n\\hline PROCEDURE RELATED COMPLICATIONS & Complications associated with any part of the vascular access procedure, associated treatments or necessary secondary interventions that do not necessarily involve the device. This includes morbidity associated with either pre-medication, or anesthesia, or other adjunct to the surgical procedure. Other technical errors including inappropriate subject selection, inappropriate operator techniques, measurements, or judgment that do not involve the device itself are also included. \\\\\n\\hline PROCEDURERELATED EVENTS & Events occurring during or as a direct result of the index procedure. \\\\\n\\hline REPEAT PROCEDURE FOR VALVERELATED DYSFUNCTION & Any surgical or percutaneous interventional catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve. In addition to surgical re-operations, enzymatic, balloon dilatation, interventional manipulation, repositioning, or retrieval, and other catheter-based interventions for valve-related complications are also considered re-interventions. Cardiac re-interventions will be \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Table 26.2-1: Definitions}\n\\begin{tabular}{|l|l|}\n\\hline Term & Definition \\\\\n\\hline DYSFUNCTION & \\begin{tabular}{l}\nregurgitation of the operated valve or hemolysis. The term nonstructural dysfunction refers to problems (exclusive of thrombosis and infection) that do not directly involve valve components yet result in dysfunction of an operated valve, as diagnosed by re-operation, autopsy, or clinical investigation. Nonstructural dysfunction includes the following. \\\\\n- Entrapment by pannus, tissue, or suture \\\\\n- Paravalvular leak \\\\\n- Inappropriate sizing or positioning \\\\\n- Residual leak or obstruction after valve implantation or repair \\\\\n- Clinically important intravascular hemolytic anemia \\\\\n- Development of aortic or pulmonic regurgitation as a result of technical errors \\\\\n- Dilatation of the sinotubular junction \\\\\n- Dilatation of the valve annulus after either valve replacement with stentless prostheses, new onset of coronary ischemia from coronary ostial obstruction, or paravalvular aortic regurgitation\n\\end{tabular} \\\\\n\\hline OPERATIVE RISK & \\begin{tabular}{l}\nOperative risk is determined by a center cardiac surgeon and must be confirmed by the Case Review Committee (including a cardiac surgeon). \\\\\nExtreme Risk: Predicted operative mortality or serious, irreversible morbidity risk \\(\\geq 50 \\%\\) at 30 days \\\\\nHigh Risk: Predicted operative mortality or serious, irreversible morbidity risk \\(\\geq 15 \\%\\) at 30 days\n\\end{tabular} \\\\\n\\hline PARAVALVULAR REGURGITATION & Leakage due to a separation of the prosthetic valve from the annulus. Any evidence of leakage of blood around the device. Diagnosis of paravalvular regurgitation may be obtained from TEE/TTE, however, definitive diagnosis is obtained at reoperation, explant, or autopsy. \\\\\n\\hline PERMANENT PACEMAKER (PPM) IMPLANTATION \\({ }^{114}\\) & \\begin{tabular}{l}\nImplantation of new PPM after the index procedure resulting from new or worsened conduction disturbances \\\\\n- Procedure-related: PPM is implanted in subjects with new onset or worsened conduction disturbances occurring post index procedure \\\\\n- Not related to procedure: PPM is implanted in subjects with known conduction disturbances that did not advance after the index procedure. \\\\\nNote 1: See also definitions for arrhythmia and conductance disturbance.\n\\end{tabular} \\\\\n\\hline PORCELAIN AORTA & Heavy circumferential calcification of the entire ascending aorta extending to the arch such that aortic cross-clamping is not feasible \\\\\n\\hline PROCEDURE RELATED COMPLICATIONS & Complications associated with any part of the vascular access procedure, associated treatments or necessary secondary interventions that do not necessarily involve the device. This includes morbidity associated with either pre-medication, or anesthesia, or other adjunct to the surgical procedure. Other technical errors including inappropriate subject selection, inappropriate operator techniques, measurements, or judgment that do not involve the device itself are also included. \\\\\n\\hline PROCEDURERELATED EVENTS & Events occurring during or as a direct result of the index procedure. \\\\\n\\hline REPEAT PROCEDURE FOR VALVERELATED DYSFUNCTION & Any surgical or percutaneous interventional catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve. In addition to surgical re-operations, enzymatic, balloon dilatation, interventional manipulation, repositioning, or retrieval, and other catheter-based interventions for valve-related complications are also considered re-interventions. Cardiac re-interventions will be 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of the operated valve or hemolysis. The term nonstructural dysfunction refers to problems (exclusive of thrombosis and infection) that do not directly involve valve components yet result in dysfunction of an operated valve, as diagnosed by re-operation, autopsy, or clinical investigation. Nonstructural dysfunction includes the following. \\\\\n- Entrapment by pannus, tissue, or suture \\\\\n- Paravalvular leak \\\\\n- Inappropriate sizing or positioning \\\\\n- Residual leak or obstruction after valve implantation or repair \\\\\n- Clinically important intravascular hemolytic anemia \\\\\n- Development of aortic or pulmonic regurgitation as a result of technical errors \\\\\n- Dilatation of the sinotubular junction \\\\\n- Dilatation of the valve annulus after either valve replacement with stentless prostheses, new onset of coronary ischemia from coronary ostial obstruction, or paravalvular aortic regurgitation\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nregurgitation of the operated valve or hemolysis. The term nonstructural dysfunction refers to problems (exclusive of thrombosis and infection) that do not directly involve valve components yet result in dysfunction of an operated valve, as diagnosed by re-operation, autopsy, or clinical investigation. Nonstructural dysfunction includes the following. \\\\\n- Entrapment by pannus, tissue, or suture \\\\\n- Paravalvular leak \\\\\n- Inappropriate sizing or positioning \\\\\n- Residual leak or obstruction after valve implantation or repair \\\\\n- Clinically important intravascular hemolytic anemia \\\\\n- Development of aortic or pulmonic regurgitation as a result of technical errors \\\\\n- Dilatation of the sinotubular junction \\\\\n- Dilatation of the valve annulus after either valve replacement with stentless prostheses, new onset of coronary ischemia from coronary ostial obstruction, or paravalvular aortic regurgitation\n\\end{tabular}","cell_row":1,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[703,459],[1710,459],[1710,498],[703,498]],"region":{"top_left_x":702,"top_left_y":459,"width":1008,"height":40},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"afa66fda3497437a8a392ddcdcaf3b4a","type":"text","conversion_output":false,"parent_id":"f236ee5ac0814f92a6c762290bb479c1","text":"regurgitation of the operated valve or hemolysis. The term nonstructural","text_display":"regurgitation of the operated valve or hemolysis. The term nonstructural","confidence":1,"confidence_rate":1},{"cnt":[[703,501],[1848,501],[1848,537],[703,537]],"region":{"top_left_x":702,"top_left_y":500,"width":1147,"height":38},"line":25,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"07cf6e92623b4e7eae818e6a0cb6a619","type":"text","conversion_output":false,"parent_id":"f236ee5ac0814f92a6c762290bb479c1","text":"dysfunction refers to problems (exclusive of thrombosis and infection) that do not","text_display":" dysfunction refers to problems (exclusive of thrombosis and infection) that do not","confidence":1,"confidence_rate":1},{"cnt":[[703,540],[1870,540],[1870,579],[703,579]],"region":{"top_left_x":702,"top_left_y":539,"width":1168,"height":40},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bc994111775b4fba92af7e4d9a5e3c6e","type":"text","conversion_output":false,"parent_id":"f236ee5ac0814f92a6c762290bb479c1","text":"directly involve valve components yet result in dysfunction of an operated valve, as","text_display":" directly involve valve components yet result in dysfunction of an operated valve, as","confidence":1,"confidence_rate":1},{"cnt":[[703,579],[1749,579],[1749,618],[703,618]],"region":{"top_left_x":702,"top_left_y":578,"width":1047,"height":40},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8016d1c5086b4767867ffd88069d36c0","type":"text","conversion_output":false,"parent_id":"f236ee5ac0814f92a6c762290bb479c1","text":"diagnosed by re-operation, autopsy, or clinical investigation. Nonstructural","text_display":" diagnosed by re-operation, autopsy, or clinical investigation. 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suture","confidence":1,"confidence_rate":1},{"cnt":[[707,713],[989,713],[989,745],[707,745]],"region":{"top_left_x":707,"top_left_y":712,"width":282,"height":34},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1d95c7c47ab940a8a86465bf84aa3194","type":"text","conversion_output":false,"parent_id":"f236ee5ac0814f92a6c762290bb479c1","text":"- Paravalvular leak","text_display":"\n- Paravalvular leak","confidence":1,"confidence_rate":1},{"cnt":[[707,756],[1229,756],[1229,797],[707,797]],"region":{"top_left_x":707,"top_left_y":756,"width":522,"height":42},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5d22b78e3b2e4b8c9b768b6c3b13ba0b","type":"text","conversion_output":false,"parent_id":"f236ee5ac0814f92a6c762290bb479c1","text":"- Inappropriate sizing or positioning","text_display":"\n- Inappropriate sizing or 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intravascular hemolytic anemia","confidence":1,"confidence_rate":1},{"cnt":[[707,895],[1835,895],[1835,934],[707,934]],"region":{"top_left_x":707,"top_left_y":894,"width":1129,"height":40},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ecb9bbddb1be4cd1869657e0c6c37ce0","type":"text","conversion_output":false,"parent_id":"f236ee5ac0814f92a6c762290bb479c1","text":"- Development of aortic or pulmonic regurgitation as a result of technical errors","text_display":"\n- Development of aortic or pulmonic regurgitation as a result of technical errors","confidence":1,"confidence_rate":1},{"cnt":[[707,942],[1261,942],[1261,979],[707,979]],"region":{"top_left_x":707,"top_left_y":942,"width":555,"height":38},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"28a72c3faf1748fc891df402b0fe8fea","type":"text","conversion_output":false,"parent_id":"f236ee5ac0814f92a6c762290bb479c1","text":"- Dilatation of the sinotubular junction","text_display":"\n- Dilatation of the sinotubular junction","confidence":1,"confidence_rate":1},{"cnt":[[705,986],[1792,986],[1792,1027],[705,1027]],"region":{"top_left_x":704,"top_left_y":985,"width":1089,"height":42},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"129f4cb51f444dfa931829d4da57e1d7","type":"text","conversion_output":false,"parent_id":"f236ee5ac0814f92a6c762290bb479c1","text":"- Dilatation of the valve annulus after either valve replacement with stentless","text_display":"\n- Dilatation of the valve annulus after either valve replacement with stentless","confidence":1,"confidence_rate":1},{"cnt":[[742,1027],[1866,1027],[1866,1066],[742,1066]],"region":{"top_left_x":741,"top_left_y":1026,"width":1125,"height":40},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"900e6d08592b41a698f2a75d62f7b5d0","type":"text","conversion_output":false,"parent_id":"f236ee5ac0814f92a6c762290bb479c1","text":"prostheses, new onset of coronary ischemia from coronary ostial obstruction, or","text_display":" prostheses, new onset of coronary ischemia from coronary ostial obstruction, or","confidence":1,"confidence_rate":1},{"cnt":[[742,1068],[1197,1068],[1197,1105],[742,1105]],"region":{"top_left_x":741,"top_left_y":1067,"width":456,"height":38},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3559d87e300a42f0ae3619aa52d550ad","type":"text","conversion_output":false,"parent_id":"f236ee5ac0814f92a6c762290bb479c1","text":"paravalvular aortic regurgitation","text_display":" paravalvular aortic regurgitation","confidence":1,"confidence_rate":1},{"cnt":[[309,1116],[597,1116],[597,1148],[309,1148]],"region":{"top_left_x":308,"top_left_y":1115,"width":289,"height":34},"line":39,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9734bffb432d4430a2085bc6f0757a34","type":"simple_cell","conversion_output":false,"parent_id":"b86a44ac89374d89b7be73791506fe09","text":"OPERATIVE RISK","text_display":"OPERATIVE RISK","cell_row":2,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[698,1107],[1872,1107],[1872,1373],[698,1373]],"region":{"top_left_x":698,"top_left_y":1106,"width":1175,"height":268},"line":40,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4e5bb128b241486ebf86c3d92a685615","type":"complex_cell","conversion_output":false,"parent_id":"b86a44ac89374d89b7be73791506fe09","children_ids":["dfd3f523b788489ba32bc33714d805f4","56a72fd57d08463baab95d9cae564c3b","ba16c0b36bda4de1836a4de1d1202a7c","989fee767384428fbbe808c0ee995a5a","bd0da67fe5104353a6c43c061718a095","a991b69f365044758a41c631f39a8a36"],"text":"\\begin{tabular}{l}\nOperative risk is determined by a center cardiac surgeon and must be confirmed by the Case Review Committee (including a cardiac surgeon). \\\\\nExtreme Risk: Predicted operative mortality or serious, irreversible morbidity risk \\(\\geq 50 \\%\\) at 30 days \\\\\nHigh Risk: Predicted operative mortality or serious, irreversible morbidity risk \\(\\geq 15 \\%\\) at 30 days\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nOperative risk is determined by a center cardiac surgeon and must be confirmed by the Case Review Committee (including a cardiac surgeon). \\\\\nExtreme Risk: Predicted operative mortality or serious, irreversible morbidity risk \\(\\geq 50 \\%\\) at 30 days \\\\\nHigh Risk: Predicted operative mortality or serious, irreversible morbidity risk \\(\\geq 15 \\%\\) at 30 days\n\\end{tabular}","cell_row":2,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[703,1111],[1866,1111],[1866,1152],[703,1152]],"region":{"top_left_x":702,"top_left_y":1111,"width":1164,"height":42},"line":41,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"dfd3f523b788489ba32bc33714d805f4","type":"text","conversion_output":false,"parent_id":"4e5bb128b241486ebf86c3d92a685615","text":"Operative risk is determined by a center cardiac surgeon and must be confirmed by","text_display":"Operative risk is determined by a center cardiac surgeon and must be confirmed by","confidence":1,"confidence_rate":1},{"cnt":[[703,1150],[1528,1150],[1528,1191],[703,1191]],"region":{"top_left_x":702,"top_left_y":1150,"width":826,"height":42},"line":42,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"56a72fd57d08463baab95d9cae564c3b","type":"text","conversion_output":false,"parent_id":"4e5bb128b241486ebf86c3d92a685615","text":"the Case Review Committee (including a cardiac surgeon).","text_display":" the Case Review Committee (including a cardiac surgeon).","confidence":1,"confidence_rate":1},{"cnt":[[703,1202],[1861,1202],[1861,1243],[703,1243]],"region":{"top_left_x":702,"top_left_y":1202,"width":1160,"height":42},"line":43,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ba16c0b36bda4de1836a4de1d1202a7c","type":"text","conversion_output":false,"parent_id":"4e5bb128b241486ebf86c3d92a685615","text":"Extreme Risk: Predicted operative mortality or serious, irreversible morbidity risk","text_display":"\nExtreme Risk: Predicted operative mortality or serious, irreversible morbidity risk","confidence":1,"confidence_rate":1},{"cnt":[[703,1241],[943,1241],[943,1282],[703,1282]],"region":{"top_left_x":702,"top_left_y":1241,"width":242,"height":42},"line":44,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"989fee767384428fbbe808c0ee995a5a","type":"text","conversion_output":false,"parent_id":"4e5bb128b241486ebf86c3d92a685615","text":"\\(\\geq 50 \\%\\) at 30 days","text_display":" \\(\\geq 50 \\%\\) at 30 days","confidence":1,"confidence_rate":1},{"cnt":[[703,1291],[1809,1291],[1809,1332],[703,1332]],"region":{"top_left_x":702,"top_left_y":1291,"width":1108,"height":42},"line":45,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bd0da67fe5104353a6c43c061718a095","type":"text","conversion_output":false,"parent_id":"4e5bb128b241486ebf86c3d92a685615","text":"High Risk: Predicted operative mortality or serious, irreversible morbidity risk","text_display":"\nHigh Risk: Predicted operative mortality or serious, irreversible morbidity risk","confidence":1,"confidence_rate":1},{"cnt":[[703,1332],[941,1332],[941,1373],[703,1373]],"region":{"top_left_x":702,"top_left_y":1332,"width":239,"height":42},"line":46,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a991b69f365044758a41c631f39a8a36","type":"text","conversion_output":false,"parent_id":"4e5bb128b241486ebf86c3d92a685615","text":"\\(\\geq 15 \\%\\) at 30 days","text_display":" \\(\\geq 15 \\%\\) at 30 days","confidence":1,"confidence_rate":1},{"cnt":[[306,1380],[601,1380],[601,1460],[306,1460]],"region":{"top_left_x":306,"top_left_y":1379,"width":295,"height":81},"line":47,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a498ed19f7b84a8f86b2f5de445edd4c","type":"complex_cell","conversion_output":false,"parent_id":"b86a44ac89374d89b7be73791506fe09","children_ids":["56b150fa155b40a1bf8109d330e15712","e4ceb6015f9847f0906e03ec00072566"],"text":"PARAVALVULAR REGURGITATION","text_display":"PARAVALVULAR REGURGITATION","cell_row":3,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[309,1382],[601,1382],[601,1412],[309,1412]],"region":{"top_left_x":308,"top_left_y":1381,"width":293,"height":32},"line":48,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"56b150fa155b40a1bf8109d330e15712","type":"text","conversion_output":false,"parent_id":"a498ed19f7b84a8f86b2f5de445edd4c","text":"PARAVALVULAR","text_display":"PARAVALVULAR","confidence":1,"confidence_rate":1},{"cnt":[[311,1423],[601,1423],[601,1453],[311,1453]],"region":{"top_left_x":310,"top_left_y":1423,"width":291,"height":31},"line":49,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e4ceb6015f9847f0906e03ec00072566","type":"text","conversion_output":false,"parent_id":"a498ed19f7b84a8f86b2f5de445edd4c","text":"REGURGITATION","text_display":" REGURGITATION","confidence":1,"confidence_rate":1},{"cnt":[[698,1380],[1874,1380],[1874,1540],[698,1540]],"region":{"top_left_x":698,"top_left_y":1379,"width":1177,"height":162},"line":50,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ffa216097e3045b8ae3ac8eb931f57cc","type":"complex_cell","conversion_output":false,"parent_id":"b86a44ac89374d89b7be73791506fe09","children_ids":["8ac346866b6744f58818d4050171a7f3","27a649cf898a41d6aa7b73dca469c8dd","53a8618a4ed64ba0953d5e6d426f47d3","765bb5cb6b4c46a2b78598932e0059cd"],"text":"Leakage due to a separation of the prosthetic valve from the annulus. Any evidence of leakage of blood around the device. Diagnosis of paravalvular regurgitation may be obtained from TEE/TTE, however, definitive diagnosis is obtained at reoperation, explant, or autopsy.","text_display":"Leakage due to a separation of the prosthetic valve from the annulus. Any evidence of leakage of blood around the device. Diagnosis of paravalvular regurgitation may be obtained from TEE/TTE, however, definitive diagnosis is obtained at reoperation, explant, or autopsy.","cell_row":3,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[703,1382],[1866,1382],[1866,1421],[703,1421]],"region":{"top_left_x":702,"top_left_y":1381,"width":1164,"height":40},"line":51,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8ac346866b6744f58818d4050171a7f3","type":"text","conversion_output":false,"parent_id":"ffa216097e3045b8ae3ac8eb931f57cc","text":"Leakage due to a separation of the prosthetic valve from the annulus. Any evidence","text_display":"Leakage due to a separation of the prosthetic valve from the annulus. Any evidence","confidence":1,"confidence_rate":1},{"cnt":[[703,1419],[1868,1419],[1868,1460],[703,1460]],"region":{"top_left_x":702,"top_left_y":1418,"width":1166,"height":42},"line":52,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"27a649cf898a41d6aa7b73dca469c8dd","type":"text","conversion_output":false,"parent_id":"ffa216097e3045b8ae3ac8eb931f57cc","text":"of leakage of blood around the device. Diagnosis of paravalvular regurgitation may","text_display":" of leakage of blood around the device. Diagnosis of paravalvular regurgitation may","confidence":1,"confidence_rate":1},{"cnt":[[703,1460],[1762,1460],[1762,1499],[703,1499]],"region":{"top_left_x":702,"top_left_y":1459,"width":1060,"height":40},"line":53,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"53a8618a4ed64ba0953d5e6d426f47d3","type":"text","conversion_output":false,"parent_id":"ffa216097e3045b8ae3ac8eb931f57cc","text":"be obtained from TEE/TTE, however, definitive diagnosis is obtained at re-","text_display":" be obtained from TEE/TTE, however, definitive diagnosis is obtained at re","confidence":1,"confidence_rate":1},{"cnt":[[703,1501],[1129,1501],[1129,1540],[703,1540]],"region":{"top_left_x":702,"top_left_y":1501,"width":428,"height":40},"line":54,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"765bb5cb6b4c46a2b78598932e0059cd","type":"text","conversion_output":false,"parent_id":"ffa216097e3045b8ae3ac8eb931f57cc","text":"operation, explant, or autopsy.","text_display":"operation, explant, or autopsy.","confidence":1,"confidence_rate":1},{"cnt":[[306,1547],[636,1547],[636,1672],[306,1672]],"region":{"top_left_x":306,"top_left_y":1546,"width":330,"height":127},"line":55,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"05869ec55d1c464399c5c43a5ee77bba","type":"complex_cell","conversion_output":false,"parent_id":"b86a44ac89374d89b7be73791506fe09","children_ids":["a4778a63f2604155aa3b8f829e5299ab","c13b0fa83fcf45efa5f2249388b09561","61f5f2b7a79f41a48020f5a6c1692951"],"text":"PERMANENT PACEMAKER (PPM) IMPLANTATION \\({ }^{114}\\)","text_display":"PERMANENT PACEMAKER (PPM) IMPLANTATION \\({ 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(PPM)","confidence":1,"confidence_rate":1},{"cnt":[[309,1622],[623,1622],[623,1668],[309,1668]],"region":{"top_left_x":308,"top_left_y":1622,"width":315,"height":46},"line":58,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"61f5f2b7a79f41a48020f5a6c1692951","type":"text","conversion_output":false,"parent_id":"05869ec55d1c464399c5c43a5ee77bba","text":"IMPLANTATION \\({ }^{114}\\)","text_display":" IMPLANTATION \\({ }^{114}\\)","confidence":0.99951171875,"confidence_rate":0.9999819112562659},{"cnt":[[698,1547],[1883,1547],[1883,1845],[698,1845]],"region":{"top_left_x":698,"top_left_y":1546,"width":1185,"height":300},"line":59,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4ee954bce4984912814c03615278881f","type":"complex_cell","conversion_output":false,"parent_id":"b86a44ac89374d89b7be73791506fe09","children_ids":["b78507ae055b493d85b86d6da3be4665","39b42b16015f4e2d8ae43bcbdea0b96a","a695df7269644c969227f212301edbc8","820dabc513da4233bab6c453b9fc9ba0","f5b246cb742e4c86bef9db2ad5d05142","8811af04e8ad4f14810edfc646d902c1","f1d5a65d034849cfb982428c9cfaa5fa"],"text":"\\begin{tabular}{l}\nImplantation of new PPM after the index procedure resulting from new or worsened conduction disturbances \\\\\n- Procedure-related: PPM is implanted in subjects with new onset or worsened conduction disturbances occurring post index procedure \\\\\n- Not related to procedure: PPM is implanted in subjects with known conduction disturbances that did not advance after the index procedure. \\\\\nNote 1: See also definitions for arrhythmia and conductance disturbance.\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nImplantation of new PPM after the index procedure resulting from new or worsened conduction disturbances \\\\\n- Procedure-related: PPM is implanted in subjects with new onset or worsened conduction disturbances occurring post index procedure \\\\\n- Not related to procedure: PPM is implanted in subjects with known conduction disturbances that did not advance after the index procedure. \\\\\nNote 1: See also definitions for arrhythmia and conductance 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Term & Definition \\\\\n\\hline & \\begin{tabular}{l}\ncategorized as repeat TAVR, valvuloplasty, or surgical AVR. \\\\\n- Conversion to open surgery \\\\\n- Conversion to open sternotomy during the TAVR procedure secondary to any procedure-related complications. \\\\\n- Unplanned use of CPB \\\\\n- Unplanned use of CPB for hemodynamic support at any time during the TAVR procedure.\n\\end{tabular} \\\\\n\\hline RESPIRATORY INSUFFICIENCY & Inadequate ventilation or oxygenation \\\\\n\\hline RESPIRATORY FAILURE & The need for ventilatory support for \\(>72\\) hours associated with an inability to wean from the respirator for any reason. \\\\\n\\hline RIGHT VENTRICULAR INSUFFICIENCY & \\begin{tabular}{l}\n- Defined as sequelae of right ventricular failure including the following. \\\\\n- Significantly decreased right ventricular systolic and/or diastolic function \\\\\n- Tricuspid valvular regurgitation secondary to elevated pressure \\\\\n- Clinical symptoms to include the following. 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14155:2011) & records, laboratory notes, device accountability records, photograhic negatives, radiographs, records kept at the investigation center, at the laboratories and at the medico-technical departments involvced in the clinical investigation. \\\\\n\\hline STROKE \\({ }^{72,73}\\) & \\begin{tabular}{l}\nStroke is defined as an acute episode of focal or global neurological dysfunction caused by brain, spinal cord, or retinal vascular injury as a result of hemorrhage or infarction \\\\\nStroke Classification \\\\\n- Ischemic Stroke is defined as an acute episode of focal cerebral, spinal, or retinal dysfunction caused by an infarction of central nervous system tissue. \\\\\n- Hemorrhagic Stroke is defined as an acute episode of focal or global cerebral or spinal dysfunction caused by an intraparenchymal, intraventricular, or subarachnoid hemorrhage \\\\\nNote 1: The CEC will adjudicate ischemic versus hemorrhagic stroke. \\\\\nNote 2: A stroke may be classified as undetermined if 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neurosurgical specialist \\\\\n- Neuroimaging procedure (MRI or CT scan), but stroke may be diagnosed on clinical grounds alone \\\\\nNote 3: Subjects with non-focal global encephalopathy will not be reported as a stroke without unequivocal evidence based upon neuroimaging studies (CT scan or brain MRI). \\\\\nStroke Definitions \\\\\nDiagnosis as above, preferably with positive neuroimaging study \\\\\n- Non-disabling: Modified Rankin Scale (mRS) score \\(<2\\) at 90 days OR one that does not result in an increase of at least one mRS category from an individual's pre-stroke baseline \\\\\n- Disabling: Modified Rankin Scale score \\(\\geq 2\\) at 90 days AND an increase of at least one mRS category from an individual's pre-stroke baseline \\\\\nNote 4: Modified Rankin Scale assessments should be made by a neurology professional or by qualified individuals according to a certification process. \\\\\nNote 5: Assessment of the mRS score should occur at all scheduled visits in a study; mRS also should be performed after a stroke and at 90 days after the onset of any stroke.\n\\end{tabular} \\\\\n\\hline STRUCTURAL VALVE DETERIORATION & \\begin{tabular}{l}\nComponent of time-related valve safety defined as follows. \\\\\n- Valve-related dysfunction: Mean aortic valve gradient \\(\\geq 20 mmHg\\), EOA\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Table 26.2-1: Definitions}\n\\begin{tabular}{|l|l|}\n\\hline Term & Definition \\\\\n\\hline (per ISO 14155:2011) & records, laboratory notes, device accountability records, photograhic negatives, radiographs, records kept at the investigation center, at the laboratories and at the medico-technical departments involvced in the clinical investigation. \\\\\n\\hline STROKE \\({ }^{72,73}\\) & \\begin{tabular}{l}\nStroke is defined as an acute episode of focal or global neurological dysfunction caused by brain, spinal cord, or retinal vascular injury as 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\\(<2\\) at 90 days OR one that does not result in an increase of at least one mRS category from an individual's pre-stroke baseline \\\\\n- Disabling: Modified Rankin Scale score \\(\\geq 2\\) at 90 days AND an increase of at least one mRS category from an individual's pre-stroke baseline \\\\\nNote 4: Modified Rankin Scale assessments should be made by a neurology professional or by qualified individuals according to a certification process. \\\\\nNote 5: Assessment of the mRS score should occur at all scheduled visits in a study; mRS also should be performed after a stroke and at 90 days after the onset of any stroke.\n\\end{tabular} \\\\\n\\hline STRUCTURAL VALVE DETERIORATION & \\begin{tabular}{l}\nComponent of time-related valve safety defined as follows. \\\\\n- Valve-related dysfunction: Mean aortic valve gradient \\(\\geq 20 mmHg\\), EOA\n\\end{tabular} 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is defined as an acute episode of focal or global neurological dysfunction caused by brain, spinal cord, or retinal vascular injury as a result of hemorrhage or infarction \\\\\nStroke Classification \\\\\n- Ischemic Stroke is defined as an acute episode of focal cerebral, spinal, or retinal dysfunction caused by an infarction of central nervous system tissue. \\\\\n- Hemorrhagic Stroke is defined as an acute episode of focal or global cerebral or spinal dysfunction caused by an intraparenchymal, intraventricular, or subarachnoid hemorrhage \\\\\nNote 1: The CEC will adjudicate ischemic versus hemorrhagic stroke. \\\\\nNote 2: A stroke may be classified as undetermined if there is insufficient information to allow categorization as ischemic or hemorrhagic \\\\\nStroke Diagnostic Criteria \\\\\n- Rapid onset of a focal or global neurological deficit with at least one of the following: change in level of consciousness, hemiplegia, hemiparesis, numbness or sensory loss affecting one side of the body, dysphasia or aphasia, hemianopia, amaurosis fugax, or other neurological signs or symptoms consistent with stroke \\\\\n- Duration of a focal or global neurological deficit \\(\\geq 24 h\\); OR \\(<24 h\\), if available neuroimaging documents a new hemorrhage or infarct; OR the neurological deficit results in death \\\\\n- No other readily identifiable nonstroke cause for the clinical presentation (e.g., brain tumor, trauma, infection, hypoglycemia, peripheral lesion, pharmacological influences), to be determined by or in conjunction with designated neurologist \\\\\n- Confirmation of the diagnosis by at least one of the following. \\\\\n- Neurology or neurosurgical specialist \\\\\n- Neuroimaging procedure (MRI or CT scan), but stroke may be diagnosed on clinical grounds alone \\\\\nNote 3: Subjects with non-focal global encephalopathy will not be reported as a stroke without unequivocal evidence based upon neuroimaging studies (CT scan or brain MRI). \\\\\nStroke Definitions \\\\\nDiagnosis as above, preferably with positive neuroimaging study \\\\\n- Non-disabling: Modified Rankin Scale (mRS) score \\(<2\\) at 90 days OR one that does not result in an increase of at least one mRS category from an individual's pre-stroke baseline \\\\\n- Disabling: Modified Rankin Scale score \\(\\geq 2\\) at 90 days AND an increase of at least one mRS category from an individual's pre-stroke baseline \\\\\nNote 4: Modified Rankin Scale assessments should be made by a neurology professional or by qualified individuals according to a certification process. \\\\\nNote 5: Assessment of the mRS score should occur at all scheduled visits in a study; mRS also should be performed after a stroke and at 90 days after the onset of any stroke.\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nStroke is defined as an acute episode of focal or global neurological dysfunction caused by brain, spinal cord, or retinal vascular injury as a result of hemorrhage or infarction \\\\\nStroke Classification \\\\\n- Ischemic Stroke is defined as an acute episode of focal cerebral, spinal, or retinal dysfunction caused by an infarction of central nervous system tissue. \\\\\n- Hemorrhagic Stroke is defined as an acute episode of focal or global cerebral or spinal dysfunction caused by an intraparenchymal, intraventricular, or subarachnoid hemorrhage \\\\\nNote 1: The CEC will adjudicate ischemic versus hemorrhagic stroke. \\\\\nNote 2: A stroke may be classified as undetermined if there is insufficient information to allow categorization as ischemic or hemorrhagic \\\\\nStroke Diagnostic Criteria \\\\\n- Rapid onset of a focal or global neurological deficit with at least one of the following: change in level of consciousness, hemiplegia, hemiparesis, numbness or sensory loss affecting one side of the body, dysphasia or aphasia, hemianopia, amaurosis fugax, or other neurological signs or symptoms consistent with stroke \\\\\n- Duration of a focal or global neurological deficit \\(\\geq 24 h\\); OR \\(<24 h\\), if available neuroimaging documents a new hemorrhage or infarct; OR the neurological deficit results in death \\\\\n- No other readily identifiable nonstroke cause for the clinical presentation (e.g., brain tumor, trauma, infection, hypoglycemia, peripheral lesion, pharmacological influences), to be determined by or in conjunction with designated neurologist \\\\\n- Confirmation of the diagnosis by at least one of the following. \\\\\n- Neurology or neurosurgical specialist \\\\\n- Neuroimaging procedure (MRI or CT scan), but stroke may be diagnosed on clinical grounds alone \\\\\nNote 3: Subjects with non-focal global encephalopathy will not be reported as a stroke without unequivocal evidence based upon neuroimaging studies (CT scan or brain MRI). \\\\\nStroke Definitions \\\\\nDiagnosis as above, preferably with positive neuroimaging study \\\\\n- Non-disabling: Modified Rankin Scale (mRS) score \\(<2\\) at 90 days OR one that does not result in an increase of at least one mRS category from an individual's pre-stroke baseline \\\\\n- Disabling: Modified Rankin Scale score \\(\\geq 2\\) at 90 days AND an increase of at least one mRS category from an individual's pre-stroke baseline \\\\\nNote 4: Modified Rankin Scale assessments should be made by a neurology professional or by qualified individuals according to a certification process. \\\\\nNote 5: Assessment of the mRS score should occur at all scheduled visits in a study; mRS also should be performed after a stroke and at 90 days after the onset of any stroke.\n\\end{tabular}","cell_row":2,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.84814453125,"confidence_rate":0.999946021116795},{"cnt":[[705,613],[1822,613],[1822,650],[705,650]],"region":{"top_left_x":704,"top_left_y":613,"width":1119,"height":38},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d3c99eacc901439fb78b51da0a5fe316","type":"text","conversion_output":false,"parent_id":"3ef8b1956bbc427c9609ee67b0f18c72","text":"Stroke is defined as an acute episode of focal or global neurological dysfunction","text_display":"Stroke is defined as an acute episode of focal or global neurological dysfunction","confidence":0.9990234375,"confidence_rate":0.9999886391383975},{"cnt":[[705,652],[1853,652],[1853,691],[705,691]],"region":{"top_left_x":704,"top_left_y":652,"width":1149,"height":40},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b4e3d710b79b49f3a642c0e4f5cb1e71","type":"text","conversion_output":false,"parent_id":"3ef8b1956bbc427c9609ee67b0f18c72","text":"caused by brain, spinal cord, or retinal vascular injury as a result of hemorrhage or","text_display":" caused by brain, spinal cord, or retinal vascular injury as a result of hemorrhage or","confidence":1,"confidence_rate":1},{"cnt":[[705,691],[844,691],[844,724],[705,724]],"region":{"top_left_x":704,"top_left_y":691,"width":140,"height":33},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9d292222354e42d59acc61b2e848520f","type":"text","conversion_output":false,"parent_id":"3ef8b1956bbc427c9609ee67b0f18c72","text":"infarction","text_display":" infarction","confidence":1,"confidence_rate":1},{"cnt":[[705,743],[1017,743],[1017,776],[705,776]],"region":{"top_left_x":704,"top_left_y":743,"width":313,"height":33},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4f4281abc3af4b4c92778156597a8894","type":"text","conversion_output":false,"parent_id":"3ef8b1956bbc427c9609ee67b0f18c72","text":"Stroke Classification","text_display":"\nStroke Classification","confidence":1,"confidence_rate":1},{"cnt":[[707,786],[1866,786],[1866,828],[707,828]],"region":{"top_left_x":707,"top_left_y":786,"width":1159,"height":42},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"73835c06bf9a4ab5bc9d04932b815788","type":"text","conversion_output":false,"parent_id":"3ef8b1956bbc427c9609ee67b0f18c72","text":"- Ischemic Stroke is defined as an acute episode of focal cerebral, spinal, or retinal","text_display":"\n- Ischemic Stroke is defined as an acute episode of focal cerebral, spinal, or retinal","confidence":1,"confidence_rate":1},{"cnt":[[737,830],[1697,830],[1697,867],[737,867]],"region":{"top_left_x":737,"top_left_y":829,"width":960,"height":38},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"544e1c080c174cc3a5855b2441b63ede","type":"text","conversion_output":false,"parent_id":"3ef8b1956bbc427c9609ee67b0f18c72","text":"dysfunction caused by an infarction of central nervous system tissue.","text_display":" dysfunction caused by an infarction of central nervous system tissue.","confidence":0.99951171875,"confidence_rate":0.9999934000150488},{"cnt":[[707,873],[1855,873],[1855,912],[707,912]],"region":{"top_left_x":707,"top_left_y":873,"width":1148,"height":40},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"938f3462674b481b86e6a7ff26184d86","type":"text","conversion_output":false,"parent_id":"3ef8b1956bbc427c9609ee67b0f18c72","text":"- Hemorrhagic Stroke is defined as an acute episode of focal or global cerebral or","text_display":"\n- Hemorrhagic Stroke is defined as an acute episode of focal or global cerebral or","confidence":1,"confidence_rate":1},{"cnt":[[737,916],[1718,916],[1718,953],[737,953]],"region":{"top_left_x":737,"top_left_y":916,"width":982,"height":38},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5c1df0cd7a244adb9da38a943ae07685","type":"text","conversion_output":false,"parent_id":"3ef8b1956bbc427c9609ee67b0f18c72","text":"spinal dysfunction caused by an intraparenchymal, intraventricular, or","text_display":" spinal dysfunction caused by an intraparenchymal, intraventricular, or","confidence":1,"confidence_rate":1},{"cnt":[[737,955],[1103,955],[1103,992],[737,992]],"region":{"top_left_x":737,"top_left_y":955,"width":367,"height":38},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8164cb566ba543629a14ff37914c99bc","type":"text","conversion_output":false,"parent_id":"3ef8b1956bbc427c9609ee67b0f18c72","text":"subarachnoid hemorrhage","text_display":" subarachnoid hemorrhage","confidence":1,"confidence_rate":1},{"cnt":[[707,999],[1682,999],[1682,1035],[707,1035]],"region":{"top_left_x":707,"top_left_y":998,"width":975,"height":38},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7651b6075a044244afc3111ac6939d6a","type":"text","conversion_output":false,"parent_id":"3ef8b1956bbc427c9609ee67b0f18c72","text":"Note 1: The CEC will adjudicate ischemic versus hemorrhagic stroke.","text_display":"\nNote 1: The CEC will adjudicate ischemic versus hemorrhagic stroke.","confidence":1,"confidence_rate":1},{"cnt":[[707,1042],[1736,1042],[1736,1079],[707,1079]],"region":{"top_left_x":707,"top_left_y":1041,"width":1029,"height":38},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"28d074133c38454e990dbf82f4b214c3","type":"text","conversion_output":false,"parent_id":"3ef8b1956bbc427c9609ee67b0f18c72","text":"Note 2: A stroke may be classified as undetermined if there is insufficient","text_display":"\nNote 2: A stroke may be classified as undetermined if there is insufficient","confidence":1,"confidence_rate":1},{"cnt":[[707,1081],[1593,1081],[1593,1118],[707,1118]],"region":{"top_left_x":707,"top_left_y":1080,"width":886,"height":38},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d2752eae7ce948faa50bad8cc0446c59","type":"text","conversion_output":false,"parent_id":"3ef8b1956bbc427c9609ee67b0f18c72","text":"information to allow categorization as ischemic or hemorrhagic","text_display":" information to allow categorization as ischemic or hemorrhagic","confidence":1,"confidence_rate":1},{"cnt":[[705,1124],[1099,1124],[1099,1165],[705,1165]],"region":{"top_left_x":704,"top_left_y":1124,"width":396,"height":42},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b4b5813c605d485dbe62faf1626672c9","type":"text","conversion_output":false,"parent_id":"3ef8b1956bbc427c9609ee67b0f18c72","text":"Stroke Diagnostic Criteria","text_display":"\nStroke Diagnostic Criteria","confidence":1,"confidence_rate":1},{"cnt":[[705,1172],[1788,1172],[1788,1209],[705,1209]],"region":{"top_left_x":704,"top_left_y":1171,"width":1084,"height":38},"line":39,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4aa90342a605493682ceadbf1bc42bf6","type":"text","conversion_output":false,"parent_id":"3ef8b1956bbc427c9609ee67b0f18c72","text":"- Rapid onset of a focal or global neurological deficit with at least one of the","text_display":"\n- Rapid onset of a focal or global neurological deficit with at least one of the","confidence":1,"confidence_rate":1},{"cnt":[[742,1211],[1861,1211],[1861,1248],[742,1248]],"region":{"top_left_x":741,"top_left_y":1210,"width":1121,"height":38},"line":40,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5b05f083a77548e7a049f625ffeca843","type":"text","conversion_output":false,"parent_id":"3ef8b1956bbc427c9609ee67b0f18c72","text":"following: change in level of consciousness, hemiplegia, hemiparesis, numbness","text_display":" following: change in level of consciousness, hemiplegia, hemiparesis, numbness","confidence":1,"confidence_rate":1},{"cnt":[[742,1250],[1866,1250],[1866,1289],[742,1289]],"region":{"top_left_x":741,"top_left_y":1249,"width":1125,"height":40},"line":41,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"40dbf9caebe248af8db9a418ca26b821","type":"text","conversion_output":false,"parent_id":"3ef8b1956bbc427c9609ee67b0f18c72","text":"or sensory loss affecting one side of the body, dysphasia or aphasia, hemianopia,","text_display":" or sensory loss affecting one side of the body, dysphasia or aphasia, hemianopia,","confidence":1,"confidence_rate":1},{"cnt":[[742,1293],[1866,1293],[1866,1328],[742,1328]],"region":{"top_left_x":741,"top_left_y":1293,"width":1125,"height":35},"line":42,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ae5060be16694c02b0b51e527f6653de","type":"text","conversion_output":false,"parent_id":"3ef8b1956bbc427c9609ee67b0f18c72","text":"amaurosis fugax, or other neurological signs or symptoms consistent with stroke","text_display":" amaurosis fugax, or other neurological signs or symptoms consistent with stroke","confidence":1,"confidence_rate":1},{"cnt":[[707,1336],[1848,1336],[1848,1373],[707,1373]],"region":{"top_left_x":707,"top_left_y":1336,"width":1142,"height":38},"line":43,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0ecbddddb1f9440e9ff80f4ccc148a55","type":"text","conversion_output":false,"parent_id":"3ef8b1956bbc427c9609ee67b0f18c72","text":"- Duration of a focal or global neurological deficit \\(\\geq 24 h\\); OR \\(<24 h\\), if available","text_display":"\n- Duration of a focal or global neurological deficit \\(\\geq 24 h\\); OR \\(<24 h\\), if available","confidence":0.84814453125,"confidence_rate":0.998337704157672},{"cnt":[[742,1378],[1801,1375],[1801,1413],[742,1416]],"region":{"top_left_x":741,"top_left_y":1374,"width":1060,"height":42},"line":44,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a907eb6a62f34d16b60e95e0b42e2567","type":"text","conversion_output":false,"parent_id":"3ef8b1956bbc427c9609ee67b0f18c72","text":"neuroimaging documents a new hemorrhage or infarct; OR the neurological","text_display":" neuroimaging documents a new hemorrhage or infarct; OR the neurological","confidence":1,"confidence_rate":1},{"cnt":[[742,1419],[1056,1419],[1056,1447],[742,1447]],"region":{"top_left_x":741,"top_left_y":1418,"width":315,"height":29},"line":45,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"93b387fe222f4bd687803f21e440f60b","type":"text","conversion_output":false,"parent_id":"3ef8b1956bbc427c9609ee67b0f18c72","text":"deficit results in death","text_display":" deficit results in death","confidence":1,"confidence_rate":1},{"cnt":[[705,1462],[1840,1462],[1840,1501],[705,1501]],"region":{"top_left_x":704,"top_left_y":1462,"width":1136,"height":40},"line":46,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"af3757f8c3ee4a48adc072571bc385a7","type":"text","conversion_output":false,"parent_id":"3ef8b1956bbc427c9609ee67b0f18c72","text":"- No other readily identifiable nonstroke cause for the clinical presentation (e.g.,","text_display":"\n- No other readily identifiable nonstroke cause for the clinical presentation (e.g.,","confidence":1,"confidence_rate":1},{"cnt":[[742,1501],[1874,1501],[1874,1538],[742,1538]],"region":{"top_left_x":741,"top_left_y":1501,"width":1134,"height":37},"line":47,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bc52c9204525471bbec7bd86db170cc4","type":"text","conversion_output":false,"parent_id":"3ef8b1956bbc427c9609ee67b0f18c72","text":"brain tumor, trauma, infection, hypoglycemia, peripheral lesion, pharmacological","text_display":" brain tumor, trauma, infection, hypoglycemia, peripheral lesion, pharmacological","confidence":1,"confidence_rate":1},{"cnt":[[742,1549],[1835,1549],[1835,1586],[742,1586]],"region":{"top_left_x":741,"top_left_y":1548,"width":1095,"height":38},"line":48,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a704752a72094113a69907899a03d15e","type":"text","conversion_output":false,"parent_id":"3ef8b1956bbc427c9609ee67b0f18c72","text":"influences), to be determined by or in conjunction with designated neurologist","text_display":" influences), to be determined by or in conjunction with designated neurologist","confidence":1,"confidence_rate":1},{"cnt":[[705,1596],[1610,1596],[1610,1633],[705,1633]],"region":{"top_left_x":704,"top_left_y":1596,"width":907,"height":38},"line":49,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"503f0a33b7bd4213b5b4836e3842fe3d","type":"text","conversion_output":false,"parent_id":"3ef8b1956bbc427c9609ee67b0f18c72","text":"- Confirmation of the diagnosis by at least one of the following.","text_display":"\n- Confirmation of the diagnosis by at least one of the following.","confidence":1,"confidence_rate":1},{"cnt":[[742,1640],[1307,1640],[1307,1676],[742,1676]],"region":{"top_left_x":741,"top_left_y":1639,"width":566,"height":38},"line":50,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"50205b76856a46818879c9c01b5ca496","type":"text","conversion_output":false,"parent_id":"3ef8b1956bbc427c9609ee67b0f18c72","text":"- Neurology or neurosurgical specialist","text_display":"\n- Neurology or neurosurgical 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Term & Definition \\\\\n\\hline & \\begin{tabular}{l}\n\\(\\leq 0.9-1.1 cm^{2}\\), and/or DVI \\(<0.35\\) AND/OR moderate or severe prosthetic valve regurgitation (per VARC definition) \\\\\n- Requiring repeat procedure (TAVR or SAVR).\n\\end{tabular} \\\\\n\\hline TAV-IN-TAV DEPLOYMENT & An additional valve prosthesis is implanted within a previously implanted prosthesis because of suboptimal device position and/or function during or after the index procedure. \\\\\n\\hline TRANSIENT ISCHEMIC ATTACK (TIA) & \\begin{tabular}{l}\n- Transient episode of focal neurological dysfunction caused by brain, spinal cord, or retinal ischemia, without acute infarction \\\\\n- Duration of a focal or global neurological deficit is \\(<24 h\\) \\\\\n- Neuroimaging does not demonstrate a new hemorrhage or infarct (if performed) Note: The difference between TIA and ischemic stroke is the presence of tissue damage or new sensory-motor deficit persisting >24 hours. By definition, TIA does not produce lasting disability.\n\\end{tabular} \\\\\n\\hline UNANTICIPATED ADVERSE DEVICE EFFECT Ref: 21CFR Part 812 (UADE) & Any serious adverse effect on health or safety or any life-threatening problem or death caused by, or associated with a device, if that effect, problem, or death was not previously identified in nature, severity, or degree of incidence in the protocol or application (including a supplementary plan or application), or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects. \\\\\n\\hline UNANTICIPATED SERIOUS ADVERSE DEVICE EFFECT Ref: ISO 14155:2011 (USADE) & Serious adverse device effect which by its nature, incidence, severity, or outcome has not been identified in the current version of the risk analysis report Note 1: An anticipated serious adverse device effect (ASADE) is an effect which by its nature, incidence, severity, or outcome has been identified in the risk analysis report. \\\\\n\\hline UNPLANNED USE OF CARDIOPULMONARY BYPASS & Unplanned use of cardiopulmonary bypass for hemodynamic support at any time during the TAVR procedure \\\\\n\\hline VALVE EMBOLIZATION & The valve prosthesis moves during or after deployment such that it loses contact with the aortic annulus. \\\\\n\\hline VALVE MALPOSITIONING & Includes valve migration, valve embolization, or ectopic valve deployment \\\\\n\\hline VALVE MIGRATION & After initial correct positioning the valve prosthesis moves upward or downward within the aortic annulus from its initial position, with or without consequences (e.g., regurgitation). \\\\\n\\hline VALVE-RELATED DYSFUNCTION & Mean aortic valve gradient \\(\\geq 20 mmHg\\), \\(EOA \\leq 0.9-1.1 cm^{2}\\), and/or DVI \\(<0.35\\) AND/OR moderate or severe prosthetic valve aortic regurgitation (per VARC definition) \\\\\n\\hline VALVE-RELATED SYMPTOMS/CHF REQUIRING HOSPITALIZATION & The need for hospitalization associated with valve-related symptoms or worsening CHF (NYHA Class III or IV) is intended to serve as a basis for calculation of a \"days alive outside the hospital\" endpoint. Included are heart failure, angina, or syncope due to aortic valve disease requiring intervention or intensified medical management; clinical symptoms of CHF with objective signs including pulmonary edema, hypoperfusion, or documented volume overload AND administration of intravenous diuresis or inotropic therapy, performance of aortic valvuloplasty, institution of mechanical support (intra-aortic balloon pump or ventilation for pulmonary edema), or hemodialysis for volume overload; clear documentation of anginal symptoms AND no clinical evidence that angina was related to coronary \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Table 26.2-1: Definitions}\n\\begin{tabular}{|l|l|}\n\\hline Term & Definition \\\\\n\\hline & \\begin{tabular}{l}\n\\(\\leq 0.9-1.1 cm^{2}\\), and/or DVI \\(<0.35\\) AND/OR moderate or severe prosthetic valve regurgitation (per VARC definition) \\\\\n- Requiring repeat procedure (TAVR or SAVR).\n\\end{tabular} \\\\\n\\hline TAV-IN-TAV DEPLOYMENT & An additional valve prosthesis is implanted within a previously implanted prosthesis because of suboptimal device position and/or function during or after the index procedure. \\\\\n\\hline TRANSIENT ISCHEMIC ATTACK (TIA) & \\begin{tabular}{l}\n- Transient episode of focal neurological dysfunction caused by brain, spinal cord, or retinal ischemia, without acute infarction \\\\\n- Duration of a focal or global neurological deficit is \\(<24 h\\) \\\\\n- Neuroimaging does not demonstrate a new hemorrhage or infarct (if performed) Note: The difference between TIA and ischemic stroke is the presence of tissue damage or new sensory-motor deficit persisting >24 hours. By definition, TIA does not produce lasting disability.\n\\end{tabular} \\\\\n\\hline UNANTICIPATED ADVERSE DEVICE EFFECT Ref: 21CFR Part 812 (UADE) & Any serious adverse effect on health or safety or any life-threatening problem or death caused by, or associated with a device, if that effect, problem, or death was not previously identified in nature, severity, or degree of incidence in the protocol or application (including a supplementary plan or application), or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects. \\\\\n\\hline UNANTICIPATED SERIOUS ADVERSE DEVICE EFFECT Ref: ISO 14155:2011 (USADE) & Serious adverse device effect which by its nature, incidence, severity, or outcome has not been identified in the current version of the risk analysis report Note 1: An anticipated serious adverse device effect (ASADE) is an effect which by its nature, incidence, severity, or outcome has been identified in the risk analysis report. \\\\\n\\hline UNPLANNED USE OF CARDIOPULMONARY BYPASS & Unplanned use of cardiopulmonary bypass for hemodynamic support at any time during the TAVR procedure \\\\\n\\hline VALVE EMBOLIZATION & The valve prosthesis moves during or after deployment such that it loses contact with the aortic annulus. \\\\\n\\hline VALVE MALPOSITIONING & Includes valve migration, valve embolization, or ectopic valve deployment \\\\\n\\hline VALVE MIGRATION & After initial correct positioning the valve prosthesis moves upward or downward within the aortic annulus from its initial position, with or without consequences (e.g., regurgitation). \\\\\n\\hline VALVE-RELATED DYSFUNCTION & Mean aortic valve gradient \\(\\geq 20 mmHg\\), \\(EOA \\leq 0.9-1.1 cm^{2}\\), and/or DVI \\(<0.35\\) AND/OR moderate or severe prosthetic valve aortic regurgitation (per VARC definition) \\\\\n\\hline VALVE-RELATED SYMPTOMS/CHF REQUIRING HOSPITALIZATION & The need for hospitalization associated with valve-related symptoms or worsening CHF (NYHA Class III or IV) is intended to serve as a basis for calculation of a \"days alive outside the hospital\" endpoint. Included are heart failure, angina, or syncope due to aortic valve disease requiring intervention or intensified medical management; clinical symptoms of CHF with objective signs including pulmonary edema, hypoperfusion, or documented volume overload AND administration of intravenous diuresis or inotropic therapy, performance of aortic valvuloplasty, institution of mechanical support (intra-aortic balloon pump or ventilation for pulmonary edema), or hemodialysis for volume overload; clear documentation of anginal symptoms AND no clinical evidence that angina was related to coronary 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Note that valve-associated thrombus identified at autopsy in a patient whose cause of death was not valve-related or at operation for an unrelated indication should not be reported as valve thrombosis. \\\\\n\\hline VASCULAR ACCESS SITE AND ACCESS RELATED COMPLICATIONS & \\begin{tabular}{l}\nMajor Vascular Complications \\\\\n- Any aortic dissection, aortic rupture, annulus rupture, left ventricle perforation, or new apical aneurysm/pseudoaneurysm \\\\\n- Access site or access-related vascular injury (dissection, stenosis, perforation, rupture, arterio-venous fistula, pseudoaneurysm, hematoma, irreversible nerve injury, compartment syndrome, percutaneous closure device failure*) leading to death, life-threatening or major bleeding**, visceral ischaemia, or neurological impairment \\\\\n- Distal embolization (non-cerebral) from a vascular source requiring surgery or resulting in amputation or irreversible end-organ damage \\\\\n- The use of unplanned endovascular or surgical intervention associated with death, major bleeding, visceral ischaemia or neurological impairment \\\\\n- Any new ipsilateral lower extremity ischemia documented by patient symptoms, physical exam, and/or decreased or absent blood flow on lower extremity angiogram \\\\\n- Surgery for access site-related nerve injury \\\\\n- Permanent access site-related nerve injury \\\\\nMinor Vascular Complications \\\\\n- Access site or access-related vascular injury (dissection, stenosis, perforation, rupture, arterio-venous fistula, pseudoaneurysms , hematomas, percutaneous closure device failure*) not leading to death, life-threatening or major bleeding**, visceral ischaemia or neurological impairment \\\\\n- Distal embolization treated with embolectomy and/or thrombectomy and not resulting in amputation or irreversible end-organ damage \\\\\n- Any unplanned endovascular stenting or unplanned surgical intervention not meeting the criteria for a major vascular complication \\\\\n- Vascular repair or the need for vascular repair (via surgery, ultrasound-guided compression, transcatheter embolization, or stent-graft) \\\\\n*Percutaneous Closure Device Failure \\\\\nFailure of a closure device to achieve hemostasis at the arteriotomy site leading to alternative treatment (other than manual compression or adjunctive endovascular ballooning) \\\\\nNote 1: Pre-planned surgical access or a planned endovascular approach to vascular closure (e.g., \"pre-closure\") \\({ }^{128,129}\\) should be considered as part of the TAVR procedure and not as a complication, unless untoward clinical consequences are documented (e.g., bleeding complications, limb ischemia, distal embolization, or neurological impairment). \\\\\nNote 2: If unplanned percutaneous or surgical intervention does not lead to adverse outcomes this is not considered a major vascular complication. \\\\\n** Refers to VARC bleeding definitions \\({ }^{72,73}\\)\n\\end{tabular} \\\\\n\\hline VENTRICULAR & Angiographic or echocardiographic evidence of a new septal perforation during or \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Table 26.2-1: Definitions}\n\\begin{tabular}{|l|l|}\n\\hline Term & Definition \\\\\n\\hline & artery disease or acute coronary syndrome; documented loss of consciousness not related to seizure or tachyarrhythmia. \\\\\n\\hline VALVE THROMBOSIS & Any thrombus attached to or near an implanted valve that occludes part of the blood flow path, interferes with valve function, or is sufficiently large to warrant treatment. Note that valve-associated thrombus identified at autopsy in a patient whose cause of death was not valve-related or at operation for an unrelated indication should not be reported as valve thrombosis. \\\\\n\\hline VASCULAR ACCESS SITE AND ACCESS RELATED COMPLICATIONS & \\begin{tabular}{l}\nMajor Vascular Complications \\\\\n- Any aortic dissection, aortic rupture, annulus rupture, left ventricle perforation, or new apical aneurysm/pseudoaneurysm \\\\\n- Access site or access-related vascular injury (dissection, stenosis, perforation, rupture, arterio-venous fistula, pseudoaneurysm, hematoma, irreversible nerve injury, compartment syndrome, percutaneous closure device failure*) leading to death, life-threatening or major bleeding**, visceral ischaemia, or neurological impairment \\\\\n- Distal embolization (non-cerebral) from a vascular source requiring surgery or resulting in amputation or irreversible end-organ damage \\\\\n- The use of unplanned endovascular or surgical intervention associated with death, major bleeding, visceral ischaemia or neurological impairment \\\\\n- Any new ipsilateral lower extremity ischemia documented by patient symptoms, physical exam, and/or decreased or absent blood flow on lower extremity angiogram \\\\\n- Surgery for access site-related nerve injury \\\\\n- Permanent access site-related nerve injury \\\\\nMinor Vascular Complications \\\\\n- Access site or access-related vascular injury (dissection, stenosis, perforation, rupture, arterio-venous fistula, pseudoaneurysms , hematomas, percutaneous closure device failure*) not leading to death, life-threatening or major bleeding**, visceral ischaemia or neurological impairment \\\\\n- Distal embolization treated with embolectomy and/or thrombectomy and not resulting in amputation or irreversible end-organ damage \\\\\n- Any unplanned endovascular stenting or unplanned surgical intervention not meeting the criteria for a major vascular complication \\\\\n- Vascular repair or the need for vascular repair (via surgery, ultrasound-guided compression, transcatheter embolization, or stent-graft) \\\\\n*Percutaneous Closure Device Failure \\\\\nFailure of a closure device to achieve hemostasis at the arteriotomy site leading to alternative treatment (other than manual compression or adjunctive endovascular ballooning) \\\\\nNote 1: Pre-planned surgical access or a planned endovascular approach to vascular closure (e.g., \"pre-closure\") \\({ }^{128,129}\\) should be considered as part of the TAVR procedure and not as a complication, unless untoward clinical consequences are documented (e.g., bleeding complications, limb ischemia, distal embolization, or neurological impairment). \\\\\nNote 2: If unplanned percutaneous or surgical intervention does not lead to adverse outcomes this is not considered a major vascular complication. \\\\\n** Refers to VARC bleeding definitions \\({ }^{72,73}\\)\n\\end{tabular} \\\\\n\\hline VENTRICULAR & Angiographic or 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Note that valve-associated thrombus identified at autopsy in a patient","text_display":" treatment. Note that valve-associated thrombus identified at autopsy in a patient","confidence":1,"confidence_rate":1},{"cnt":[[705,670],[1749,670],[1749,706],[705,706]],"region":{"top_left_x":704,"top_left_y":669,"width":1045,"height":38},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"557a17429a9e4a74a01c63a5bbc8c5a6","type":"text","conversion_output":false,"parent_id":"ec0834c4190746eabc184ce733608b21","text":"whose cause of death was not valve-related or at operation for an unrelated","text_display":" whose cause of death was not valve-related or at operation for an unrelated","confidence":1,"confidence_rate":1},{"cnt":[[705,708],[1459,708],[1459,745],[705,745]],"region":{"top_left_x":704,"top_left_y":708,"width":755,"height":38},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3c4f9bd7dd2740d795add1090de3a8e8","type":"text","conversion_output":false,"parent_id":"ec0834c4190746eabc184ce733608b21","text":"indication should 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Vascular Complications \\\\\n- Any aortic dissection, aortic rupture, annulus rupture, left ventricle perforation, or new apical aneurysm/pseudoaneurysm \\\\\n- Access site or access-related vascular injury (dissection, stenosis, perforation, rupture, arterio-venous fistula, pseudoaneurysm, hematoma, irreversible nerve injury, compartment syndrome, percutaneous closure device failure*) leading to death, life-threatening or major bleeding**, visceral ischaemia, or neurological impairment \\\\\n- Distal embolization (non-cerebral) from a vascular source requiring surgery or resulting in amputation or irreversible end-organ damage \\\\\n- The use of unplanned endovascular or surgical intervention associated with death, major bleeding, visceral ischaemia or neurological impairment \\\\\n- Any new ipsilateral lower extremity ischemia documented by patient symptoms, physical exam, and/or decreased or absent blood flow on lower extremity angiogram \\\\\n- Surgery for access site-related nerve injury \\\\\n- Permanent access site-related nerve injury \\\\\nMinor Vascular Complications \\\\\n- Access site or access-related vascular injury (dissection, stenosis, perforation, rupture, arterio-venous fistula, pseudoaneurysms , hematomas, percutaneous closure device failure*) not leading to death, life-threatening or major bleeding**, visceral ischaemia or neurological impairment \\\\\n- Distal embolization treated with embolectomy and/or thrombectomy and not resulting in amputation or irreversible end-organ damage \\\\\n- Any unplanned endovascular stenting or unplanned surgical intervention not meeting the criteria for a major vascular complication \\\\\n- Vascular repair or the need for vascular repair (via surgery, ultrasound-guided compression, transcatheter embolization, or stent-graft) \\\\\n*Percutaneous Closure Device Failure \\\\\nFailure of a closure device to achieve hemostasis at the arteriotomy site leading to alternative treatment (other than manual compression or adjunctive endovascular ballooning) \\\\\nNote 1: Pre-planned surgical access or a planned endovascular approach to vascular closure (e.g., \"pre-closure\") \\({ }^{128,129}\\) should be considered as part of the TAVR procedure and not as a complication, unless untoward clinical consequences are documented (e.g., bleeding complications, limb ischemia, distal embolization, or neurological impairment). \\\\\nNote 2: If unplanned percutaneous or surgical intervention does not lead to adverse outcomes this is not considered a major vascular complication. \\\\\n** Refers to VARC bleeding definitions \\({ }^{72,73}\\)\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nMajor Vascular Complications \\\\\n- Any aortic dissection, aortic rupture, annulus rupture, left ventricle perforation, or new apical aneurysm/pseudoaneurysm \\\\\n- Access site or access-related vascular injury (dissection, stenosis, perforation, rupture, arterio-venous fistula, pseudoaneurysm, hematoma, irreversible nerve injury, compartment syndrome, percutaneous closure device failure*) leading to death, life-threatening or major bleeding**, visceral ischaemia, or neurological impairment \\\\\n- Distal embolization (non-cerebral) from a vascular source requiring surgery or resulting in amputation or irreversible end-organ damage \\\\\n- The use of unplanned endovascular or surgical intervention associated with death, major bleeding, visceral ischaemia or neurological impairment \\\\\n- Any new ipsilateral lower extremity ischemia documented by patient symptoms, physical exam, and/or decreased or absent blood flow on lower extremity angiogram \\\\\n- Surgery for access site-related nerve injury \\\\\n- Permanent access site-related nerve injury \\\\\nMinor Vascular Complications \\\\\n- Access site or access-related vascular injury (dissection, stenosis, perforation, rupture, arterio-venous fistula, pseudoaneurysms , hematomas, percutaneous closure device failure*) not leading to death, life-threatening or major bleeding**, visceral ischaemia or neurological impairment \\\\\n- Distal embolization treated with embolectomy and/or thrombectomy and not resulting in amputation or irreversible end-organ damage \\\\\n- Any unplanned endovascular stenting or unplanned surgical intervention not meeting the criteria for a major vascular complication \\\\\n- Vascular repair or the need for vascular repair (via surgery, ultrasound-guided compression, transcatheter embolization, or stent-graft) \\\\\n*Percutaneous Closure Device Failure \\\\\nFailure of a closure device to achieve hemostasis at the arteriotomy site leading to alternative treatment (other than manual compression or adjunctive endovascular ballooning) \\\\\nNote 1: Pre-planned surgical access or a planned endovascular approach to vascular closure (e.g., \"pre-closure\") \\({ }^{128,129}\\) should be considered as part of the TAVR procedure and not as a complication, unless untoward clinical consequences are documented (e.g., bleeding complications, limb ischemia, distal embolization, or neurological impairment). \\\\\nNote 2: If unplanned percutaneous or surgical intervention does not lead to adverse outcomes this is not considered a major vascular complication. \\\\\n** Refers to VARC bleeding definitions \\({ }^{72,73}\\)\n\\end{tabular}","cell_row":3,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.9970703125,"confidence_rate":0.9999975243097017},{"cnt":[[703,756],[1168,756],[1168,797],[703,797]],"region":{"top_left_x":702,"top_left_y":756,"width":467,"height":42},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"448a0cf41b76402c82d1b77b83bd506a","type":"text","conversion_output":false,"parent_id":"09652f2b7a614be5b11f3ff46c84628c","text":"Major Vascular Complications","text_display":"Major Vascular 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Protocol Synopsis, Test Devices and Sizes & The Lotus Valve System is an investigational device consisting of two... & The Lotus Valve System consists of two... & \\multirow{5}{*}{} \\\\\n\\hline 2. Protocol Synopsis, Control Device and Sizes & \\begin{tabular}{l}\nAlthough commercially available in other countries, the selfexpanding CoreValve \\({ }^{\\text {® }}\\) Transcatheter Aortic Valve Replacement System (CoreValve) is an unapproved medical device available to Authorized Prescribers in Australia. It is introduced... \\\\\nNote 1: Every subject... control (CoreValve) valve size available to Authorized Prescribers in Australia at the investigational center... \\\\\nNote 2: A center…size matrix if it is available, but only...\n\\end{tabular} & \\begin{tabular}{l}\nCommercially available self-expanding CoreValve \\({ }^{\\circledR}\\) \\\\\nTranscatheter Aortic Valve Replacement System (CoreValve) that is introduced... \\\\\nNote 1: Every subject... test (Lotus) device and the control (CoreValve) device. The CoreValve device in the planned size must be approved for use and commercially available at the investigational center... \\\\\nNote 2: A center…size matrix if it is approved and commercially available, but only...\n\\end{tabular} & \\\\\n\\hline 2. Protocol Synopsis, Study Design & REPRISE III is a prospective, multicenter, 2:1 randomized (Lotus Valve System versus CoreValve... & REPRISE III is a prospective, multicenter, 2:1 randomized (Lotus Valve System versus a commercially available CoreValve... & \\\\\n\\hline 2. Protocol Synopsis, Additional Measurements & \\begin{tabular}{l}\n◯ Neurological physical exam at discharge and 1 year (conducted by a neurologist or neurology fellow) \\\\\nNote 4: For subjects diagnosed with a neurological event... a neurological physical exam (conducted by a neurologist or neurology fellow), NIHSS assessment...\n\\end{tabular} & \\begin{tabular}{l}\n◯ Neurological physical exam at discharge and 1 year (conducted by a neurologist, neurology fellow, neurology physician assistant, or neurology nurse practitioner) \\\\\nNote 4: For subjects diagnosed with a neurological event... a neurological physical exam (conducted by a neurologist, neurology fellow, neurology physician assistant, or neurology nurse practitioner), NIHSS assessment...\n\\end{tabular} & \\\\\n\\hline 2. Protocol Synopsis, Adjunctive Pharmacologic Therapy & \\begin{tabular}{l}\nNote: If a subject requires chronic anticoagulation with warfarin (other anticoagulants are not permitted), either clopidogrel or aspirin is required prior to and after the implant procedure in addition to the anticoagulant therapy (but both aspirin and clopidogrel are not required). Subjects treated with warfarin should not be treated with a \\(P 2 Y _{12}\\) inhibitor other than clopidogrel. \\\\\nc: Holmes, D. R., et al. J Am Coll Cardiol. 2012;59:1200-1254 \\\\\nNishimura, R., et al. J Am Coll Cardiol. 2014;doi:\n\\end{tabular} & Note: If a subject requires chronic anticoagulation, either clopidogrel or aspirin is required prior to and after the implant procedure in addition to the anticoagulant therapy (but both aspirin and clopidogrel are not required). After the implant procedure, the subject must be treated with warfarin (other anticoagulants are not permitted in the first month) and either clopidogrel (other \\(P 2_{12} Y _{12}\\) inhibitors are not permitted in combination with warfarin) or aspirin for at least 1 month. After 1 month, subjects requiring chronic anticoagulation may be switched from warfarin to a new oral anticoagulant (NOAC) at & \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Table 27.1-3: Table of Changes for REPRISE III Protocol Version AD (Compared to REPRISE III Protocol Version AC)}\n\\begin{tabular}{|l|l|l|l|}\n\\hline Section Modified & Text as Written in REPRISE III Protocol Version AC & Text as Written in REPRISE III Protocol Version AD & Justification for Modification \\\\\n\\hline 2. Protocol Synopsis, Test Devices and Sizes & The Lotus Valve System is an investigational device consisting of two... & The Lotus Valve System consists of two... & \\multirow{5}{*}{} \\\\\n\\hline 2. Protocol Synopsis, Control Device and Sizes & \\begin{tabular}{l}\nAlthough commercially available in other countries, the selfexpanding CoreValve \\({ }^{\\text {® }}\\) Transcatheter Aortic Valve Replacement System (CoreValve) is an unapproved medical device available to Authorized Prescribers in Australia. 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Protocol Synopsis, Study Design & REPRISE III is a prospective, multicenter, 2:1 randomized (Lotus Valve System versus CoreValve... & REPRISE III is a prospective, multicenter, 2:1 randomized (Lotus Valve System versus a commercially available CoreValve... & \\\\\n\\hline 2. Protocol Synopsis, Additional Measurements & \\begin{tabular}{l}\n◯ Neurological physical exam at discharge and 1 year (conducted by a neurologist or neurology fellow) \\\\\nNote 4: For subjects diagnosed with a neurological event... a neurological physical exam (conducted by a neurologist or neurology fellow), NIHSS assessment...\n\\end{tabular} & \\begin{tabular}{l}\n◯ Neurological physical exam at discharge and 1 year (conducted by a neurologist, neurology fellow, neurology physician assistant, or neurology nurse practitioner) \\\\\nNote 4: For subjects diagnosed with a neurological event... a neurological physical exam (conducted by a neurologist, neurology fellow, neurology physician assistant, or neurology nurse practitioner), NIHSS assessment...\n\\end{tabular} & \\\\\n\\hline 2. Protocol Synopsis, Adjunctive Pharmacologic Therapy & \\begin{tabular}{l}\nNote: If a subject requires chronic anticoagulation with warfarin (other anticoagulants are not permitted), either clopidogrel or aspirin is required prior to and after the implant procedure in addition to the anticoagulant therapy (but both aspirin and clopidogrel are not required). Subjects treated with warfarin should not be treated with a \\(P 2 Y _{12}\\) inhibitor other than clopidogrel. \\\\\nc: Holmes, D. R., et al. J Am Coll Cardiol. 2012;59:1200-1254 \\\\\nNishimura, R., et al. J Am Coll Cardiol. 2014;doi:\n\\end{tabular} & Note: If a subject requires chronic anticoagulation, either clopidogrel or aspirin is required prior to and after the implant procedure in addition to the anticoagulant therapy (but both aspirin and clopidogrel are not required). 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The subject should not receive a \\(P 2 Y _{12}\\) inhibitor in combination with a NOAC but may be treated with a NOAC plus aspirin. \\\\\nc: Holmes, D. R., et al. J Am Coll Cardiol. 2012;59:1200-1254 \\\\\nNishimura, R., et al. J Am Coll Cardiol. 2014;63:2438-88\n\\end{tabular} & \\\\\n\\hline \\multirow[t]{2}{*}{2. Protocol Synopsis, Inclusion Criteria} & IC1. Subject has... an initial AVA of \\(\\leq 1.0 cm^{2}\\) (or AVA index of \\(<0.6 cm^{2} / m ^{2}\\) ) and a mean pressure gradient \\(>40 mmHg\\) or jet velocity \\(>4.0 m / s \\ldots\\) echocardiography. & IC1. 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The subject should not receive a \\(P 2 Y _{12}\\) inhibitor in combination with a NOAC but may be treated with a NOAC plus aspirin. \\\\\nc: Holmes, D. R., et al. J Am Coll Cardiol. 2012;59:1200-1254 \\\\\nNishimura, R., et al. J Am Coll Cardiol. 2014;63:2438-88\n\\end{tabular} & \\\\\n\\hline \\multirow[t]{2}{*}{2. Protocol Synopsis, Inclusion Criteria} & IC1. Subject has... an initial AVA of \\(\\leq 1.0 cm^{2}\\) (or AVA index of \\(<0.6 cm^{2} / m ^{2}\\) ) and a mean pressure gradient \\(>40 mmHg\\) or jet velocity \\(>4.0 m / s \\ldots\\) echocardiography. & IC1. 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Subject is being treated with chronic anticoagulation","confidence":1,"confidence_rate":1},{"cnt":[[517,1584],[870,1584],[870,1618],[517,1618]],"region":{"top_left_x":516,"top_left_y":1583,"width":354,"height":36},"line":87,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"722126141fff4fbb9f451f811d9da948","type":"text","conversion_output":false,"parent_id":"e00a3f827cb1412d916a5b1a37e8ae12","text":"therapy other than warfarin.","text_display":" therapy other than warfarin.","confidence":1,"confidence_rate":1},{"cnt":[[517,1629],[1342,1629],[1342,1666],[517,1666]],"region":{"top_left_x":516,"top_left_y":1628,"width":826,"height":38},"line":88,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c90ae95ef7bc4df58762712c1a61317c","type":"text","conversion_output":false,"parent_id":"e00a3f827cb1412d916a5b1a37e8ae12","text":"Note: Subjects who require chronic anticoagulation with warfarin","text_display":"\nNote: Subjects who require chronic anticoagulation with warfarin","confidence":1,"confidence_rate":1},{"cnt":[[517,1666],[1268,1666],[1268,1703],[517,1703]],"region":{"top_left_x":516,"top_left_y":1665,"width":753,"height":38},"line":89,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"964f54bed231462ea919c7a1de30669e","type":"text","conversion_output":false,"parent_id":"e00a3f827cb1412d916a5b1a37e8ae12","text":"must be able to be treated additionally with either aspirin or","text_display":" must be able to be treated additionally with either aspirin or","confidence":1,"confidence_rate":1},{"cnt":[[517,1703],[671,1703],[671,1739],[517,1739]],"region":{"top_left_x":516,"top_left_y":1702,"width":155,"height":38},"line":90,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"999f522a23ec410e9d4dfdde7166088a","type":"text","conversion_output":false,"parent_id":"e00a3f827cb1412d916a5b1a37e8ae12","text":"clopidogrel.","text_display":" clopidogrel.","confidence":1,"confidence_rate":1},{"cnt":[[1374,1499],[2212,1499],[2212,1783],[1374,1783]],"region":{"top_left_x":1374,"top_left_y":1499,"width":839,"height":284},"line":91,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"88e53ebaea644cdaa927387c967e84fa","type":"complex_cell","conversion_output":false,"parent_id":"5c614bec3dc949558f0c71b8ad32adee","children_ids":["02fe6af210a745ca94e192ca97b3fe4a","499bae9d7a824380bde39b476b25a81f","a1e9e88aa5b74ffb93a29beb7532fe93","8aeb3e83f68e477cad316dbf9b8831ea","91b0bf9e0c84401faefd7ed8bf978cb3","42893f22dbf04c37b9590734770c96dd","e27a9f44ef4444f3837c52ba3a79c1b5"],"text":"\\begin{tabular}{l}\nEC6. Subject has severe (4+) aortic... \\\\\nEC11. Subject requires chronic anticoagulation therapy after the implant procedure and cannot be treated with warfarin (other anticoagulants are not permitted in the first month) for at least 1 month concomitant with either aspirin or clopidogrel. \\\\\nNote: Subjects whe require chronic anticoagulation with warfarin must be able to be treated additionally with either aspirin or\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nEC6. Subject has severe (4+) aortic... \\\\\nEC11. Subject requires chronic anticoagulation therapy after the implant procedure and cannot be treated with warfarin (other anticoagulants are not permitted in the first month) for at least 1 month concomitant with either aspirin or clopidogrel. \\\\\nNote: Subjects whe require chronic anticoagulation with warfarin must be able to be treated additionally with either aspirin or\n\\end{tabular}","cell_row":4,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":0.8392229676246643,"confidence_rate":0.9991092433303094},{"cnt":[[1379,1508],[1857,1508],[1857,1545],[1379,1545]],"region":{"top_left_x":1378,"top_left_y":1507,"width":480,"height":38},"line":92,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"02fe6af210a745ca94e192ca97b3fe4a","type":"text","conversion_output":false,"parent_id":"88e53ebaea644cdaa927387c967e84fa","text":"EC6. Subject has severe (4+) aortic...","text_display":"EC6. 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Subject requires chronic anticoagulation therapy after the","confidence":1,"confidence_rate":1},{"cnt":[[1379,1590],[2147,1590],[2147,1627],[1379,1627]],"region":{"top_left_x":1378,"top_left_y":1590,"width":770,"height":37},"line":94,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a1e9e88aa5b74ffb93a29beb7532fe93","type":"text","conversion_output":false,"parent_id":"88e53ebaea644cdaa927387c967e84fa","text":"implant procedure and cannot be treated with warfarin (other","text_display":" implant procedure and cannot be treated with warfarin (other","confidence":1,"confidence_rate":1},{"cnt":[[1379,1625],[2180,1625],[2180,1661],[1379,1661]],"region":{"top_left_x":1378,"top_left_y":1624,"width":802,"height":38},"line":95,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8aeb3e83f68e477cad316dbf9b8831ea","type":"text","conversion_output":false,"parent_id":"88e53ebaea644cdaa927387c967e84fa","text":"anticoagulants are not permitted in the first month) for at least 1","text_display":" anticoagulants are not permitted in the first month) for at least 1","confidence":1,"confidence_rate":1},{"cnt":[[1379,1659],[2052,1659],[2052,1700],[1379,1700]],"region":{"top_left_x":1378,"top_left_y":1659,"width":675,"height":42},"line":96,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"91b0bf9e0c84401faefd7ed8bf978cb3","type":"text","conversion_output":false,"parent_id":"88e53ebaea644cdaa927387c967e84fa","text":"month concomitant with either aspirin or clopidogrel.","text_display":" month concomitant with either aspirin or clopidogrel.","confidence":1,"confidence_rate":1},{"cnt":[[1379,1707],[2204,1707],[2204,1744],[1379,1744]],"region":{"top_left_x":1378,"top_left_y":1706,"width":826,"height":38},"line":97,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"42893f22dbf04c37b9590734770c96dd","type":"text","conversion_output":false,"parent_id":"88e53ebaea644cdaa927387c967e84fa","text":"Note: Subjects whe require chronic anticoagulation with warfarin","text_display":"\nNote: Subjects whe require chronic anticoagulation with warfarin","confidence":0.8392229676246643,"confidence_rate":0.9974629505202869},{"cnt":[[1379,1746],[2134,1746],[2134,1778],[1379,1778]],"region":{"top_left_x":1378,"top_left_y":1745,"width":757,"height":34},"line":98,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e27a9f44ef4444f3837c52ba3a79c1b5","type":"text","conversion_output":false,"parent_id":"88e53ebaea644cdaa927387c967e84fa","text":"must be able to be treated additionally with either aspirin or","text_display":" must be able to be treated additionally with either aspirin or","confidence":0.99951171875,"confidence_rate":0.9999927104668955},{"cnt":[[2241,1499],[2485,1499],[2485,1536],[2241,1536]],"region":{"top_left_x":2240,"top_left_y":1499,"width":246,"height":37},"line":99,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"31d28641ab544205b999b758f290c990","type":"simple_cell","conversion_output":false,"parent_id":"5c614bec3dc949558f0c71b8ad32adee","text":"Updated for clarity","text_display":"Updated for clarity","cell_row":4,"cell_column":3,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[103,2028],[312,2028],[312,2065],[103,2065]],"region":{"top_left_x":103,"top_left_y":2028,"width":209,"height":37},"line":100,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b09b8fde7d664c9f8070a49c3f89c42b","type":"page_info","conversion_output":false,"text":"Released","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1143,2032],[1605,2032],[1605,2065],[1143,2065]],"region":{"top_left_x":1142,"top_left_y":2032,"width":463,"height":33},"line":101,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c2bd158e54d942699329e959adf93f51","type":"page_info","conversion_output":false,"text":"REPRISE III Protocol","text_display":"","confidence":0.9990236759185791,"confidence_rate":0.9999609287234535},{"cnt":[[2282,2028],[2606,2028],[2606,2065],[2282,2065]],"region":{"top_left_x":2281,"top_left_y":2028,"width":326,"height":37},"line":102,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"881b661b54a24cbe9ea7d3c60bcc16ca","type":"page_info","conversion_output":false,"text":"90899936 AK. 4","text_display":"","confidence":0.99951171875,"confidence_rate":0.9999712709716212},{"cnt":[[799,2071],[1983,2071],[1983,2108],[799,2108]],"region":{"top_left_x":799,"top_left_y":2071,"width":1185,"height":37},"line":103,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8dc9d2930ee741318df8eaff052a2533","type":"page_info","conversion_output":false,"text":"Boston Scientific Confidential. 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Section Modified & Text as Written in REPRISE III Protocol Version AC & Text as Written in REPRISE III Protocol Version AD & Justification for Modification \\\\\n\\hline \\multirow{4}{*}{} & & elopidogrel. (text removed) & \\\\\n\\hline & EC9. Subject has echocardiographic evidence of new intracardiac mass, thrombus or vegetation or one requiring treatment. & EC9. Subject has echocardiographic evidence of new intracardiac vegetation or intraventricular or paravalvular thrombus. & Some intra-cardiac masses increase risk of TAVR complications whereas others do not; this update clarifies which should be included as exclusion criteria \\\\\n\\hline & EC12. Subject has active peptic ulcer disease or gastrointestinal bleed… within the past 3 months, other clinically… & EC12. Subject has had a gastrointestinal bleed... within the past 3 months, or has other clinically significant bleeding diathesis or coagulopathy that would preclude treatment with required antiplatelet regimen, or will ... & Definition of active peptic ulcer disease is considered ambiguous by some centers (i.e., are subjects who are well controlled on medical therapy considered to have the active disease). This modification clarifies this and limits the exclusion to those with increased risk of adverse events. \\\\\n\\hline & EC20. Subject has severe peripheral vascular disease including aneurysm defined as maximal luminal diameter \\(\\geq 5 cm\\) or with documented presence of thrombus, marked tortuosity, narrowing... & EC20. Subject has severe vascular disease that would preclude safe access (e.g., aneurysm with thrombus that cannot be crossed safely, marked tortuosity, significant narrowing... or vertebral disease). & Updated text is clearer about conditions that would increase the risk of adverse events. \\\\\n\\hline Table 4.1-1 & - & The table was updated with 6 new references. & Provided additional current literature information. \\\\\n\\hline 4.1.2 & The aforementioned results notwithstanding, TAVR with early & As discussed above, TAVR in patients unsuitable for SAVR has & Provided additional \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Table 27.1-3: Table of Changes for REPRISE III Protocol Version AD (Compared to REPRISE III Protocol Version AC)}\n\\begin{tabular}{|l|l|l|l|}\n\\hline Section Modified & Text as Written in REPRISE III Protocol Version AC & Text as Written in REPRISE III Protocol Version AD & Justification for Modification \\\\\n\\hline \\multirow{4}{*}{} & & elopidogrel. (text removed) & \\\\\n\\hline & EC9. Subject has echocardiographic evidence of new intracardiac mass, thrombus or vegetation or one requiring treatment. & EC9. Subject has echocardiographic evidence of new intracardiac vegetation or intraventricular or paravalvular thrombus. & Some intra-cardiac masses increase risk of TAVR complications whereas others do not; this update clarifies which should be included as exclusion criteria \\\\\n\\hline & EC12. Subject has active peptic ulcer disease or gastrointestinal bleed… within the past 3 months, other clinically… & EC12. Subject has had a gastrointestinal bleed... within the past 3 months, or has other clinically significant bleeding diathesis or coagulopathy that would preclude treatment with required antiplatelet regimen, or will ... & Definition of active peptic ulcer disease is considered ambiguous by some centers (i.e., are subjects who are well controlled on medical therapy considered to have the active disease). This modification clarifies this and limits the exclusion to those with increased risk of adverse events. \\\\\n\\hline & EC20. Subject has severe peripheral vascular disease including aneurysm defined as maximal luminal diameter \\(\\geq 5 cm\\) or with documented presence of thrombus, marked tortuosity, narrowing... & EC20. Subject has severe vascular disease that would preclude safe access (e.g., aneurysm with thrombus that cannot be crossed safely, marked tortuosity, significant narrowing... or vertebral disease). & Updated text is clearer about conditions that would increase the risk of adverse events. \\\\\n\\hline Table 4.1-1 & - & The table was updated with 6 new references. & Provided additional current literature information. \\\\\n\\hline 4.1.2 & The aforementioned results notwithstanding, TAVR with early & As discussed above, TAVR in patients unsuitable for SAVR has & Provided additional 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Cerebrovascular accidents and vascular complications associated with TAVR have been significant predictors of mortality \\({ }^{75,76}\\). The paravalvular regurgitation more commonly seen with TAVR compared to surgery has also been accompanied by higher early and late mortality \\({ }^{45,65,77}\\). While careful patient selection may serve to mitigate these risks \\({ }^{87-89}\\), device design improvements such as seen with the Lotus Valve System (Section 5.1)... \\\\\n...subjects with calcified stenotic aortic valves who... To date, data are available through 1 year \\({ }^{81} \\ldots\\) The 1 -year VARC-1... \\\\\n...and 1 year (5 in Class I, 6 in Class II; \\(P =0.004\\) ). The mean... and \\(15.4 \\pm 4.6 mmHg\\) at 1 year. Paravalvular... or absent/trivial (10/11) at 1 year...\n\\end{tabular} & \\begin{tabular}{l}\nreduced mortality \\({ }^{14,73}\\) and treatment of selected patients at high surgical risk has resulted in similar \\({ }^{64}\\) or better \\({ }^{66}\\) survival at 1 year. These results notwithstanding, TAVR with early generation devices has been associated with increased stroke risk and vascular complications when compared to SAVR \\({ }^{64-66}\\), which have been significant predictors of mortality \\({ }^{80,81}\\). There are also other infrequent but substantial complications that impact longterm outcomes and may limit the use of TAVR in lower risk subjects. Precise valve positioning can be challenging with firstgeneration devices, and valve misplacement can lead to severe problems, including coronary occlusion and valve embolization \\({ }^{82}\\). Incomplete apposition of the prosthesis with the native valve can occur in the presence of significant amounts of calcium or with suboptimal implantation, resulting in paravalvular regurgitation \\({ }^{83,84}\\). This has been associated with increased mortality in several longitudinal registries \\({ }^{45,85,86}\\). While careful patient selection may serve to mitigate these risks \\({ }^{87-89}\\), device design improvements such as seen with the Lotus Valve System (including the ability to fully reposition and retrieve the valve and a unique adaptive seal to prevent leakage, see Section 5.1)... \\\\\n... subjects with calcific aortic stenosis who... \\\\\nTo date, data are available through 2 years \\({ }^{90,92} \\ldots\\) The 2-year VARC-1... \\\\\n...and baseline and 2 years (6 in Class I, 5 in Class II; \\(P =0.004\\) ). The mean... and \\(15.4 \\pm 4.4 mmHg\\) at 2 years. Paravalvular... and absent/trivial (11/11) at 2 years...\n\\end{tabular} & current literature information and updated REPRISE I with data from 2 years to include the most current data. \\\\\n\\hline 4.1.3 REPRISE II Study & \\begin{tabular}{l}\n...enrolled 120 subjects at 14 investigative... \\\\\n...shows 6 month \\({ }^{94}\\) clinical... Mortality was \\(8.4 \\%\\) and the disabling stroke rate was \\(3.5 \\%\\). Most subjects ( \\(81 \\%\\) ) had none/trivial paravalvular aortic regurgitation at 6 months...\n\\end{tabular} & \\begin{tabular}{l}\n...enrolled 120 subjects in the main cohort at 14 investigative... ...shows 6 month \\({ }^{94}\\) and 1 year \\({ }^{95}\\) clinical. .. At 1 year, mortality was \\(11.0 \\%\\) and the disabling stroke rate was \\(3.5 \\%\\). The low paravalvular aortic regurgitation rate observed at 30 days was maintained at 1 year as most subjects ( \\(86 \\%\\) ) had none/trivial paravalvular aortic regurgitation... \\\\\nTable 4.1-3 updated with 1-year data in addition to 6-month data.\n\\end{tabular} & Updated with data from 1 year for the main cohort ( \\(N =120\\) ) and with 30-day data from the full cohort ( \\(N =250\\) ) to include the most current data available. \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Table 27.1-3: Table of Changes for REPRISE III Protocol Version AD (Compared to REPRISE III Protocol Version AC)}\n\\begin{tabular}{|l|l|l|l|}\n\\hline Section Modified & Text as Written in REPRISE III Protocol Version AC & Text as Written in REPRISE III Protocol Version AD & Justification for Modification \\\\\n\\hline REPRISE I Study & \\begin{tabular}{l}\ngeneration devices has been associated with increased stroke risk and vascular complications when compared to surgical valve replacement \\({ }^{64-66}\\). Cerebrovascular accidents and vascular complications associated with TAVR have been significant predictors of mortality \\({ }^{75,76}\\). The paravalvular regurgitation more commonly seen with TAVR compared to surgery has also been accompanied by higher early and late mortality \\({ }^{45,65,77}\\). While careful patient selection may serve to mitigate these risks \\({ }^{87-89}\\), device design improvements such as seen with the Lotus Valve System (Section 5.1)... \\\\\n...subjects with calcified stenotic aortic valves who... To date, data are available through 1 year \\({ }^{81} \\ldots\\) The 1 -year VARC-1... \\\\\n...and 1 year (5 in Class I, 6 in Class II; \\(P =0.004\\) ). The mean... and \\(15.4 \\pm 4.6 mmHg\\) at 1 year. Paravalvular... or absent/trivial (10/11) at 1 year...\n\\end{tabular} & \\begin{tabular}{l}\nreduced mortality \\({ }^{14,73}\\) and treatment of selected patients at high surgical risk has resulted in similar \\({ }^{64}\\) or better \\({ }^{66}\\) survival at 1 year. These results notwithstanding, TAVR with early generation devices has been associated with increased stroke risk and vascular complications when compared to SAVR \\({ }^{64-66}\\), which have been significant predictors of mortality \\({ }^{80,81}\\). There are also other infrequent but substantial complications that impact longterm outcomes and may limit the use of TAVR in lower risk subjects. Precise valve positioning can be challenging with firstgeneration devices, and valve misplacement can lead to severe problems, including coronary occlusion and valve embolization \\({ }^{82}\\). Incomplete apposition of the prosthesis with the native valve can occur in the presence of significant amounts of calcium or with suboptimal implantation, resulting in paravalvular regurgitation \\({ }^{83,84}\\). This has been associated with increased mortality in several longitudinal registries \\({ }^{45,85,86}\\). While careful patient selection may serve to mitigate these risks \\({ }^{87-89}\\), device design improvements such as seen with the Lotus Valve System (including the ability to fully reposition and retrieve the valve and a unique adaptive seal to prevent leakage, see Section 5.1)... \\\\\n... subjects with calcific aortic stenosis who... \\\\\nTo date, data are available through 2 years \\({ }^{90,92} \\ldots\\) The 2-year VARC-1... \\\\\n...and baseline and 2 years (6 in Class I, 5 in Class II; \\(P =0.004\\) ). The mean... and \\(15.4 \\pm 4.4 mmHg\\) at 2 years. Paravalvular... and absent/trivial (11/11) at 2 years...\n\\end{tabular} & current literature information and updated REPRISE I with data from 2 years to include the most current data. \\\\\n\\hline 4.1.3 REPRISE II Study & \\begin{tabular}{l}\n...enrolled 120 subjects at 14 investigative... \\\\\n...shows 6 month \\({ }^{94}\\) clinical... Mortality was \\(8.4 \\%\\) and the disabling stroke rate was \\(3.5 \\%\\). Most subjects ( \\(81 \\%\\) ) had none/trivial paravalvular aortic regurgitation at 6 months...\n\\end{tabular} & \\begin{tabular}{l}\n...enrolled 120 subjects in the main cohort at 14 investigative... ...shows 6 month \\({ }^{94}\\) and 1 year \\({ }^{95}\\) clinical. .. At 1 year, mortality was \\(11.0 \\%\\) and the disabling stroke rate was \\(3.5 \\%\\). 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These results notwithstanding, TAVR with early generation devices has been associated with increased stroke risk and vascular complications when compared to SAVR \\({ }^{64-66}\\), which have been significant predictors of mortality \\({ }^{80,81}\\). There are also other infrequent but substantial complications that impact longterm outcomes and may limit the use of TAVR in lower risk subjects. Precise valve positioning can be challenging with firstgeneration devices, and valve misplacement can lead to severe problems, including coronary occlusion and valve embolization \\({ }^{82}\\). Incomplete apposition of the prosthesis with the native valve can occur in the presence of significant amounts of calcium or with suboptimal implantation, resulting in paravalvular regurgitation \\({ }^{83,84}\\). This has been associated with increased mortality in several longitudinal registries \\({ }^{45,85,86}\\). 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There are also","confidence":1,"confidence_rate":1},{"cnt":[[1379,711],[2180,711],[2180,748],[1379,748]],"region":{"top_left_x":1378,"top_left_y":710,"width":802,"height":38},"line":55,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3c525cb173394a73bf1d9dfbff7ae3a9","type":"text","conversion_output":false,"parent_id":"8de0cfb38da14f5baea659e9450bc3be","text":"other infrequent but substantial complications that impact long-","text_display":" other infrequent but substantial complications that impact long","confidence":1,"confidence_rate":1},{"cnt":[[1379,748],[2139,748],[2139,782],[1379,782]],"region":{"top_left_x":1378,"top_left_y":747,"width":761,"height":36},"line":56,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"61cb4eb941094e9ba44de12c36d97724","type":"text","conversion_output":false,"parent_id":"8de0cfb38da14f5baea659e9450bc3be","text":"term outcomes and may limit the use of TAVR in lower risk","text_display":"term outcomes and may limit the use of TAVR in lower risk","confidence":1,"confidence_rate":1},{"cnt":[[1379,782],[2191,782],[2191,821],[1379,821]],"region":{"top_left_x":1378,"top_left_y":782,"width":813,"height":40},"line":57,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"61e9c9b4362a4022864557d7f157fe02","type":"text","conversion_output":false,"parent_id":"8de0cfb38da14f5baea659e9450bc3be","text":"subjects. Precise valve positioning can be challenging with first-","text_display":" subjects. 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Mortality was \\(8.4 \\%\\) and the disabling stroke rate was \\(3.5 \\%\\). Most subjects ( \\(81 \\%\\) ) had none/trivial paravalvular aortic regurgitation at 6 months...\n\\end{tabular}","text_display":"\\begin{tabular}{l}\n...enrolled 120 subjects at 14 investigative... \\\\\n...shows 6 month \\({ }^{94}\\) clinical... Mortality was \\(8.4 \\%\\) and the disabling stroke rate was \\(3.5 \\%\\). Most subjects ( \\(81 \\%\\) ) had none/trivial paravalvular aortic regurgitation at 6 months...\n\\end{tabular}","cell_row":2,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.8484381199814379,"confidence_rate":0.9991624835517638},{"cnt":[[517,1512],[1086,1512],[1086,1551],[517,1551]],"region":{"top_left_x":516,"top_left_y":1512,"width":571,"height":40},"line":88,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"765d910fa33f43c49dca11004bd69705","type":"text","conversion_output":false,"parent_id":"34797a8aaff74770939027780731c18e","text":"...enrolled 120 subjects at 14 investigative...","text_display":"...enrolled 120 subjects at 14 investigative...","confidence":0.8484381199814379,"confidence_rate":0.9971702505224707},{"cnt":[[517,1553],[1242,1553],[1242,1597],[517,1597]],"region":{"top_left_x":516,"top_left_y":1553,"width":727,"height":44},"line":89,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ec88c247928b4021872b2886afae0252","type":"text","conversion_output":false,"parent_id":"34797a8aaff74770939027780731c18e","text":"...shows 6 month \\({ }^{94}\\) clinical... 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Most subjects ( \\(81 \\%\\) ) had","confidence":0.998046875,"confidence_rate":0.9999716665631994},{"cnt":[[517,1631],[1264,1631],[1264,1670],[517,1670]],"region":{"top_left_x":516,"top_left_y":1631,"width":748,"height":40},"line":91,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b8bb7eb45f494d4784533b756a21ac46","type":"text","conversion_output":false,"parent_id":"34797a8aaff74770939027780731c18e","text":"none/trivial paravalvular aortic regurgitation at 6 months...","text_display":" none/trivial paravalvular aortic regurgitation at 6 months...","confidence":0.966796875,"confidence_rate":0.999510744905908},{"cnt":[[1374,1512],[2208,1512],[2208,1798],[1374,1798]],"region":{"top_left_x":1374,"top_left_y":1512,"width":835,"height":286},"line":92,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0a82b72ab56c4ad49450de041986e9f8","type":"complex_cell","conversion_output":false,"parent_id":"ddb7a3ea2c5b440f8ec11728e120b6f4","children_ids":["15a44ace97fd411ebc2b92829d840b82","e036cbdad2924453865ea707f89ef6d7","6784b603382a44e88cf99fac5011e6eb","30f25df266694b998e8a5e1faefaac20","17a37d0b68304759b0c8667adab15760","9d21196654734089af3bfcdb8f41cd0d","c6980fd9a9c14417ac1c8220404f8a8c"],"text":"\\begin{tabular}{l}\n...enrolled 120 subjects in the main cohort at 14 investigative... ...shows 6 month \\({ }^{94}\\) and 1 year \\({ }^{95}\\) clinical. .. At 1 year, mortality was \\(11.0 \\%\\) and the disabling stroke rate was \\(3.5 \\%\\). The low paravalvular aortic regurgitation rate observed at 30 days was maintained at 1 year as most subjects ( \\(86 \\%\\) ) had none/trivial paravalvular aortic regurgitation... \\\\\nTable 4.1-3 updated with 1-year data in addition to 6-month data.\n\\end{tabular}","text_display":"\\begin{tabular}{l}\n...enrolled 120 subjects in the main cohort at 14 investigative... ...shows 6 month \\({ }^{94}\\) and 1 year \\({ }^{95}\\) clinical. .. At 1 year, mortality was \\(11.0 \\%\\) and the disabling stroke rate was \\(3.5 \\%\\). The low paravalvular aortic regurgitation rate observed at 30 days was maintained at 1 year as most subjects ( \\(86 \\%\\) ) had none/trivial paravalvular aortic regurgitation... \\\\\nTable 4.1-3 updated with 1-year data in addition to 6-month data.\n\\end{tabular}","cell_row":2,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":0.8978045935509726,"confidence_rate":0.9994968404145479},{"cnt":[[1379,1516],[2182,1516],[2182,1558],[1379,1558]],"region":{"top_left_x":1378,"top_left_y":1516,"width":805,"height":42},"line":93,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"15a44ace97fd411ebc2b92829d840b82","type":"text","conversion_output":false,"parent_id":"0a82b72ab56c4ad49450de041986e9f8","text":"...enrolled 120 subjects in the main cohort at 14 investigative...","text_display":"...enrolled 120 subjects in the main cohort at 14 investigative...","confidence":0.8978045935509726,"confidence_rate":0.9986009427606574},{"cnt":[[1379,1560],[2171,1560],[2171,1605],[1379,1605]],"region":{"top_left_x":1378,"top_left_y":1559,"width":794,"height":47},"line":94,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e036cbdad2924453865ea707f89ef6d7","type":"text","conversion_output":false,"parent_id":"0a82b72ab56c4ad49450de041986e9f8","text":"...shows 6 month \\({ }^{94}\\) and 1 year \\({ }^{95}\\) clinical. .. At 1 year, mortality","text_display":" ...shows 6 month \\({ }^{94}\\) and 1 year \\({ }^{95}\\) clinical. .. At 1 year, mortality","confidence":0.99658203125,"confidence_rate":0.9999661013334881},{"cnt":[[1379,1603],[2130,1603],[2130,1640],[1379,1640]],"region":{"top_left_x":1378,"top_left_y":1603,"width":753,"height":37},"line":95,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6784b603382a44e88cf99fac5011e6eb","type":"text","conversion_output":false,"parent_id":"0a82b72ab56c4ad49450de041986e9f8","text":"was \\(11.0 \\%\\) and the disabling stroke rate was \\(3.5 \\%\\). The low","text_display":" was \\(11.0 \\%\\) and the disabling stroke rate was \\(3.5 \\%\\). 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The main trial cohort and the extended trial cohort had the same overall study design. The main trial cohort received additional neurologic evaluation and annual imaging assessments to determine valve frame integrity. Per the protocol, a statistically powered analysis based on the combined main and extended trial cohorts (full cohort, \\(N =250\\) ) was performed for the primary safety endpoint (mortality at 30 days). The primary safety endpoint was analyzed on an intent-totreat basis (all subjects enrolled, whether or not a study device is implanted). A one-sample \\(z\\) test was used to test the one-sided hypothesis that 30 day all-cause mortality is less than the prespecified PG of 16\\% (based on an expected rate of 9.8\\% plus a testing margin of 6.2\\%). \\\\\nTable 4.14 shows device performance endpoints, clinical outcomes, and echocardiographic outcomes through 30 days for the full cohort \\(( N =250)^{96}\\). 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REPRISE II study was subsequently expanded to enroll 130 additional subjects in the REPRISE II extended trial cohort at centers in Australia and Europe; enrollment in this extended cohort was completed in April 2014. The main trial cohort and the extended trial cohort had the same overall study design. The main trial cohort received additional neurologic evaluation and annual imaging assessments to determine valve frame integrity. Per the protocol, a statistically powered analysis based on the combined main and extended trial cohorts (full cohort, \\(N =250\\) ) was performed for the primary safety endpoint (mortality at 30 days). The primary safety endpoint was analyzed on an intent-totreat basis (all subjects enrolled, whether or not a study device is implanted). A one-sample \\(z\\) test was used to test the one-sided hypothesis that 30 day all-cause mortality is less than the prespecified PG of 16\\% (based on an expected rate of 9.8\\% plus a testing margin of 6.2\\%). \\\\\nTable 4.14 shows device performance endpoints, clinical outcomes, and echocardiographic outcomes through 30 days for the full cohort \\(( N =250)^{96}\\). Outcomes in the full cohort were similar to that reported for the main cohort (see Table 4.1 2) with a mean aortic valve gradient of \\(11.70 \\pm 6.77 mmHg\\). Mortality was \\(4.4 \\%\\) and the disabling stroke rate was \\(3.3 \\%\\). The new PPM implant rate was \\(29.6 \\%\\). Reported rates for early conduction abnormalities and the need for PPM implantation after TAVR have ranged from 3\\% to 8\\% with SAPIEN and 14\\% to 40\\% with CoreValve \\({ }^{97}\\). In a recent report, 12-month clinical outcomes were similar among subjects with and without periprocedural \\(PPM ^{98}\\). Another study (mean follow-up of \\(22 \\pm 17\\) months) found that PPM implantation post TAVR had a negative effect on left ventricular function but was not associated with any increase in overall or cardiovascular death or rehospitalization for heart failure and was a protective factor for the occurrence of sudden or unknown death \\(( P =0.023)^{99}\\). Implantation of a new PPM following TAVR with SAPIEN (retrospective analysis from the combined PARTNER trial and NRCA registry) was associated with a higher rate of repeat hospitalization at 30 days and 1 year\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nThe REPRISE II study was subsequently expanded to enroll 130 additional subjects in the REPRISE II extended trial cohort at centers in Australia and Europe; enrollment in this extended cohort was completed in April 2014. The main trial cohort and the extended trial cohort had the same overall study design. The main trial cohort received additional neurologic evaluation and annual imaging assessments to determine valve frame integrity. Per the protocol, a statistically powered analysis based on the combined main and extended trial cohorts (full cohort, \\(N =250\\) ) was performed for the primary safety endpoint (mortality at 30 days). The primary safety endpoint was analyzed on an intent-totreat basis (all subjects enrolled, whether or not a study device is implanted). A one-sample \\(z\\) test was used to test the one-sided hypothesis that 30 day all-cause mortality is less than the prespecified PG of 16\\% (based on an expected rate of 9.8\\% plus a testing margin of 6.2\\%). \\\\\nTable 4.14 shows device performance endpoints, clinical outcomes, and echocardiographic outcomes through 30 days for the full cohort \\(( N =250)^{96}\\). Outcomes in the full cohort were similar to that reported for the main cohort (see Table 4.1 2) with a mean aortic valve gradient of \\(11.70 \\pm 6.77 mmHg\\). Mortality was \\(4.4 \\%\\) and the disabling stroke rate was \\(3.3 \\%\\). The new PPM implant rate was \\(29.6 \\%\\). Reported rates for early conduction abnormalities and the need for PPM implantation after TAVR have ranged from 3\\% to 8\\% with SAPIEN and 14\\% to 40\\% with CoreValve \\({ }^{97}\\). In a recent report, 12-month clinical outcomes were similar among subjects with and without periprocedural \\(PPM ^{98}\\). Another study (mean follow-up of \\(22 \\pm 17\\) months) found that PPM implantation post TAVR had a negative effect on left ventricular function but was not associated with any increase in overall or cardiovascular death or rehospitalization for heart failure and was a protective factor for the occurrence of sudden or unknown death \\(( P =0.023)^{99}\\). Implantation of a new PPM following TAVR with SAPIEN (retrospective analysis from the combined PARTNER trial and NRCA registry) was associated with a higher rate of repeat hospitalization at 30 days and 1 year\n\\end{tabular}","cell_row":1,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":0.45894670486450195,"confidence_rate":0.9989094502835959},{"cnt":[[1379,494],[2193,494],[2193,531],[1379,531]],"region":{"top_left_x":1378,"top_left_y":494,"width":815,"height":38},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"057a8867b47342be97b711a5cbebf019","type":"text","conversion_output":false,"parent_id":"94200589892b4dde9744970a83a8390e","text":"The REPRISE II study was subsequently expanded to enroll 130","text_display":"The REPRISE II study was subsequently expanded to enroll 130","confidence":1,"confidence_rate":1},{"cnt":[[1379,533],[2156,533],[2156,570],[1379,570]],"region":{"top_left_x":1378,"top_left_y":533,"width":779,"height":38},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f987b336a4274b5da0308f0f2617bab9","type":"text","conversion_output":false,"parent_id":"94200589892b4dde9744970a83a8390e","text":"additional subjects in the REPRISE II extended trial cohort at","text_display":" additional subjects in the REPRISE II extended trial cohort at","confidence":1,"confidence_rate":1},{"cnt":[[1379,568],[2137,568],[2137,605],[1379,605]],"region":{"top_left_x":1378,"top_left_y":567,"width":759,"height":38},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9863cbffadb94719b0262ea93923ab9b","type":"text","conversion_output":false,"parent_id":"94200589892b4dde9744970a83a8390e","text":"centers in Australia and Europe; enrollment in this extended","text_display":" centers in Australia and Europe; enrollment in this extended","confidence":1,"confidence_rate":1},{"cnt":[[1379,603],[2169,603],[2169,639],[1379,639]],"region":{"top_left_x":1378,"top_left_y":602,"width":792,"height":38},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"aa55c0932f324c598f63032497078772","type":"text","conversion_output":false,"parent_id":"94200589892b4dde9744970a83a8390e","text":"cohort was completed in April 2014. The main trial cohort and","text_display":" cohort was completed in April 2014. The main trial cohort and","confidence":1,"confidence_rate":1},{"cnt":[[1379,637],[2182,637],[2182,676],[1379,676]],"region":{"top_left_x":1378,"top_left_y":637,"width":805,"height":40},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ac42b38aa8f844dd945f3f0d58c89caf","type":"text","conversion_output":false,"parent_id":"94200589892b4dde9744970a83a8390e","text":"the extended trial cohort had the same overall study design. The","text_display":" the extended trial cohort had the same overall study design. The","confidence":1,"confidence_rate":1},{"cnt":[[1379,676],[2173,676],[2173,713],[1379,713]],"region":{"top_left_x":1378,"top_left_y":676,"width":796,"height":37},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1e4c1239a1504555b0c9c106355c0b3a","type":"text","conversion_output":false,"parent_id":"94200589892b4dde9744970a83a8390e","text":"main trial cohort received additional neurologic evaluation and","text_display":" main trial cohort received additional neurologic evaluation and","confidence":1,"confidence_rate":1},{"cnt":[[1379,711],[2178,711],[2178,748],[1379,748]],"region":{"top_left_x":1378,"top_left_y":710,"width":800,"height":38},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"687f78c4f0474f5aa94ed50a33fba7be","type":"text","conversion_output":false,"parent_id":"94200589892b4dde9744970a83a8390e","text":"annual imaging assessments to determine valve frame integrity.","text_display":" annual imaging assessments to determine valve frame integrity.","confidence":1,"confidence_rate":1},{"cnt":[[1379,748],[2152,748],[2152,782],[1379,782]],"region":{"top_left_x":1378,"top_left_y":747,"width":774,"height":36},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"66f4c420e7d7438cb13ac1afe6e37f2d","type":"text","conversion_output":false,"parent_id":"94200589892b4dde9744970a83a8390e","text":"Per the protocol, a statistically powered analysis based on the","text_display":" Per the protocol, a statistically powered analysis based on the","confidence":1,"confidence_rate":1},{"cnt":[[1379,784],[2173,784],[2173,821],[1379,821]],"region":{"top_left_x":1378,"top_left_y":784,"width":796,"height":38},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"cfdc52c91d514d4ba03238bbc894be7c","type":"text","conversion_output":false,"parent_id":"94200589892b4dde9744970a83a8390e","text":"combined main and extended trial cohorts (full cohort, \\(N =250\\) )","text_display":" combined main and extended trial cohorts (full cohort, \\(N =250\\) )","confidence":0.99951171875,"confidence_rate":0.9999933096045984},{"cnt":[[1379,819],[2169,819],[2169,856],[1379,856]],"region":{"top_left_x":1378,"top_left_y":819,"width":792,"height":37},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"651b12b074674cc7bf89047dc245b2dc","type":"text","conversion_output":false,"parent_id":"94200589892b4dde9744970a83a8390e","text":"was performed for the primary safety endpoint (mortality at 30","text_display":" was performed for the primary safety endpoint (mortality at 30","confidence":1,"confidence_rate":1},{"cnt":[[1379,856],[2199,856],[2199,891],[1379,891]],"region":{"top_left_x":1378,"top_left_y":855,"width":822,"height":36},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8868a9edf3c54796b83a161f1d664184","type":"text","conversion_output":false,"parent_id":"94200589892b4dde9744970a83a8390e","text":"days). The primary safety endpoint was analyzed on an intent-to-","text_display":" days). The primary safety endpoint was analyzed on an intent-to","confidence":1,"confidence_rate":1},{"cnt":[[1379,893],[2191,893],[2191,930],[1379,930]],"region":{"top_left_x":1378,"top_left_y":892,"width":813,"height":38},"line":39,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6dd062dcf2e845399fe327ae6a267e40","type":"text","conversion_output":false,"parent_id":"94200589892b4dde9744970a83a8390e","text":"treat basis (all subjects enrolled, whether or not a study device is","text_display":"treat basis (all subjects enrolled, whether or not a study device is","confidence":1,"confidence_rate":1},{"cnt":[[1379,927],[2165,927],[2165,964],[1379,964]],"region":{"top_left_x":1378,"top_left_y":927,"width":787,"height":38},"line":40,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ca2a8360e138456bba18c177559566b2","type":"text","conversion_output":false,"parent_id":"94200589892b4dde9744970a83a8390e","text":"implanted). A one-sample \\(z\\) test was used to test the one-sided","text_display":" implanted). A one-sample \\(z\\) test was used to test the one-sided","confidence":0.45894670486450195,"confidence_rate":0.9889356482605707},{"cnt":[[1379,962],[2100,962],[2100,999],[1379,999]],"region":{"top_left_x":1378,"top_left_y":962,"width":722,"height":37},"line":41,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"87868fe5ae6f460895897492deb6f02a","type":"text","conversion_output":false,"parent_id":"94200589892b4dde9744970a83a8390e","text":"hypothesis that 30 day all-cause mortality is less than the","text_display":" hypothesis that 30 day all-cause mortality is less than the","confidence":0.99853515625,"confidence_rate":0.9999781208709562},{"cnt":[[1379,1001],[2191,1001],[2191,1038],[1379,1038]],"region":{"top_left_x":1378,"top_left_y":1001,"width":813,"height":37},"line":42,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f35ddb72ab8142fc98941dc5b380af19","type":"text","conversion_output":false,"parent_id":"94200589892b4dde9744970a83a8390e","text":"prespecified PG of 16\\% (based on an expected rate of 9.8\\% plus","text_display":" prespecified PG of 16\\% (based on an expected rate of 9.8\\% plus","confidence":0.9990234375,"confidence_rate":0.9999854174250159},{"cnt":[[1379,1036],[1710,1036],[1710,1072],[1379,1072]],"region":{"top_left_x":1378,"top_left_y":1035,"width":333,"height":38},"line":43,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"076fc5546be143f1b11267906adff871","type":"text","conversion_output":false,"parent_id":"94200589892b4dde9744970a83a8390e","text":"a testing margin of 6.2\\%).","text_display":" a testing margin of 6.2\\%).","confidence":0.81982421875,"confidence_rate":0.9936119320156048},{"cnt":[[1379,1081],[2104,1081],[2104,1118],[1379,1118]],"region":{"top_left_x":1378,"top_left_y":1081,"width":727,"height":37},"line":44,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7cd89b80915d4fbf9e776660fd46152a","type":"text","conversion_output":false,"parent_id":"94200589892b4dde9744970a83a8390e","text":"Table 4.14 shows device performance endpoints, clinical","text_display":"\nTable 4.14 shows device performance endpoints, clinical","confidence":0.99951171875,"confidence_rate":0.9999922476411908},{"cnt":[[1379,1118],[2186,1118],[2186,1153],[1379,1153]],"region":{"top_left_x":1378,"top_left_y":1117,"width":809,"height":36},"line":45,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"443706a0ab094bb7ab1e0ac5a43275dd","type":"text","conversion_output":false,"parent_id":"94200589892b4dde9744970a83a8390e","text":"outcomes, and echocardiographic outcomes through 30 days for","text_display":" outcomes, and echocardiographic outcomes through 30 days for","confidence":1,"confidence_rate":1},{"cnt":[[1379,1148],[2126,1148],[2126,1189],[1379,1189]],"region":{"top_left_x":1378,"top_left_y":1148,"width":748,"height":42},"line":46,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e396dc23198c47689bd19e0a9e0d58d8","type":"text","conversion_output":false,"parent_id":"94200589892b4dde9744970a83a8390e","text":"the full cohort \\(( N =250)^{96}\\). Outcomes in the full cohort were","text_display":" the full cohort \\(( N =250)^{96}\\). Outcomes in the full cohort were","confidence":0.9990236759185791,"confidence_rate":0.9999874769887185},{"cnt":[[1379,1187],[2199,1187],[2199,1226],[1379,1226]],"region":{"top_left_x":1378,"top_left_y":1187,"width":822,"height":40},"line":47,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5d386b45816f4a198be45307fb956d89","type":"text","conversion_output":false,"parent_id":"94200589892b4dde9744970a83a8390e","text":"similar to that reported for the main cohort (see Table 4.1 2) with","text_display":" similar to that reported for the main cohort (see Table 4.1 2) with","confidence":0.9858465194702148,"confidence_rate":0.9998099567770048},{"cnt":[[1379,1226],[2206,1226],[2206,1263],[1379,1263]],"region":{"top_left_x":1378,"top_left_y":1226,"width":828,"height":38},"line":48,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"966b110adc494d2bace9cd0d24036425","type":"text","conversion_output":false,"parent_id":"94200589892b4dde9744970a83a8390e","text":"a mean aortic valve gradient of \\(11.70 \\pm 6.77 mmHg\\). Mortality was","text_display":" a mean aortic valve gradient of \\(11.70 \\pm 6.77 mmHg\\). Mortality was","confidence":1,"confidence_rate":1},{"cnt":[[1379,1261],[2134,1261],[2134,1298],[1379,1298]],"region":{"top_left_x":1378,"top_left_y":1260,"width":757,"height":38},"line":49,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2ebc8f99afb7414ab27bda57f956f835","type":"text","conversion_output":false,"parent_id":"94200589892b4dde9744970a83a8390e","text":"\\(4.4 \\%\\) and the disabling stroke rate was \\(3.3 \\%\\). The new PPM","text_display":" \\(4.4 \\%\\) and the disabling stroke rate was \\(3.3 \\%\\). The new PPM","confidence":0.5201034997589886,"confidence_rate":0.9898374993529924},{"cnt":[[1379,1296],[2139,1296],[2139,1332],[1379,1332]],"region":{"top_left_x":1378,"top_left_y":1295,"width":761,"height":38},"line":50,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f13f1c5fcffb46dea2e2f074d70885aa","type":"text","conversion_output":false,"parent_id":"94200589892b4dde9744970a83a8390e","text":"implant rate was \\(29.6 \\%\\). Reported rates for early conduction","text_display":" implant rate was \\(29.6 \\%\\). Reported rates for early conduction","confidence":0.9990234375,"confidence_rate":0.9999856318731074},{"cnt":[[1379,1330],[2160,1330],[2160,1371],[1379,1371]],"region":{"top_left_x":1378,"top_left_y":1330,"width":783,"height":42},"line":51,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"832f0a5b54664dc29c868c35c1edd65a","type":"text","conversion_output":false,"parent_id":"94200589892b4dde9744970a83a8390e","text":"abnormalities and the need for PPM implantation after TAVR","text_display":" abnormalities and the need for PPM implantation after TAVR","confidence":1,"confidence_rate":1},{"cnt":[[1379,1369],[2195,1369],[2195,1406],[1379,1406]],"region":{"top_left_x":1378,"top_left_y":1369,"width":818,"height":37},"line":52,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0cc660cd7c2c42968154fa5c9ca6a359","type":"text","conversion_output":false,"parent_id":"94200589892b4dde9744970a83a8390e","text":"have ranged from 3\\% to 8\\% with SAPIEN and 14\\% to 40\\% with","text_display":" have ranged from 3\\% to 8\\% with SAPIEN and 14\\% to 40\\% with","confidence":0.9800705909729004,"confidence_rate":0.999675364345776},{"cnt":[[1379,1399],[2204,1399],[2204,1441],[1379,1441]],"region":{"top_left_x":1378,"top_left_y":1399,"width":826,"height":42},"line":53,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"eb3355a36ba94c63b3ec55915fd42121","type":"text","conversion_output":false,"parent_id":"94200589892b4dde9744970a83a8390e","text":"CoreValve \\({ }^{97}\\). In a recent report, 12-month clinical outcomes were","text_display":" CoreValve \\({ }^{97}\\). In a recent report, 12-month clinical outcomes were","confidence":0.5078125,"confidence_rate":0.9916689343940801},{"cnt":[[1379,1434],[2182,1434],[2182,1480],[1379,1480]],"region":{"top_left_x":1378,"top_left_y":1434,"width":805,"height":46},"line":54,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"fe9ceddc196f40569f51086fecb49eb9","type":"text","conversion_output":false,"parent_id":"94200589892b4dde9744970a83a8390e","text":"similar among subjects with and without periprocedural \\(PPM ^{98}\\).","text_display":" similar among subjects with and without periprocedural \\(PPM ^{98}\\).","confidence":0.943359375,"confidence_rate":0.9992714159040454},{"cnt":[[1379,1477],[2147,1477],[2147,1514],[1379,1514]],"region":{"top_left_x":1378,"top_left_y":1477,"width":770,"height":38},"line":55,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d89a5855d1234a93b166cdfbb3617313","type":"text","conversion_output":false,"parent_id":"94200589892b4dde9744970a83a8390e","text":"Another study (mean follow-up of \\(22 \\pm 17\\) months) found that","text_display":" Another study (mean follow-up of \\(22 \\pm 17\\) months) found that","confidence":1,"confidence_rate":1},{"cnt":[[1379,1512],[2121,1512],[2121,1549],[1379,1549]],"region":{"top_left_x":1378,"top_left_y":1512,"width":744,"height":37},"line":56,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c183e436f7454accb5b1face213f2e20","type":"text","conversion_output":false,"parent_id":"94200589892b4dde9744970a83a8390e","text":"PPM implantation post TAVR had a negative effect on left","text_display":" PPM implantation post TAVR had a negative effect on left","confidence":1,"confidence_rate":1},{"cnt":[[1379,1547],[2180,1547],[2180,1584],[1379,1584]],"region":{"top_left_x":1378,"top_left_y":1546,"width":802,"height":38},"line":57,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4a585bdd93314384a2ff3381e9ebc420","type":"text","conversion_output":false,"parent_id":"94200589892b4dde9744970a83a8390e","text":"ventricular function but was not associated with any increase in","text_display":" ventricular function but was not associated with any increase in","confidence":1,"confidence_rate":1},{"cnt":[[1379,1584],[2139,1584],[2139,1623],[1379,1623]],"region":{"top_left_x":1378,"top_left_y":1583,"width":761,"height":40},"line":58,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"38190060c7d94a65b801c1bc8c33ddf2","type":"text","conversion_output":false,"parent_id":"94200589892b4dde9744970a83a8390e","text":"overall or cardiovascular death or rehospitalization for heart","text_display":" overall or cardiovascular death or rehospitalization for heart","confidence":1,"confidence_rate":1},{"cnt":[[1379,1620],[2178,1620],[2178,1657],[1379,1657]],"region":{"top_left_x":1378,"top_left_y":1620,"width":800,"height":38},"line":59,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8cdb7b5cabd847c9bfe7d443e313c9ee","type":"text","conversion_output":false,"parent_id":"94200589892b4dde9744970a83a8390e","text":"failure and was a protective factor for the occurrence of sudden","text_display":" failure and was a protective factor for the occurrence of sudden","confidence":1,"confidence_rate":1},{"cnt":[[1379,1651],[2128,1651],[2128,1692],[1379,1692]],"region":{"top_left_x":1378,"top_left_y":1650,"width":750,"height":42},"line":60,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"10ad80a62b8e4ba996b8407bc874ee05","type":"text","conversion_output":false,"parent_id":"94200589892b4dde9744970a83a8390e","text":"or unknown death \\(( P =0.023)^{99}\\). Implantation of a new PPM","text_display":" or unknown death \\(( P =0.023)^{99}\\). Implantation of a new PPM","confidence":0.8840122222900391,"confidence_rate":0.9983353817418255},{"cnt":[[1379,1690],[2182,1690],[2182,1729],[1379,1729]],"region":{"top_left_x":1378,"top_left_y":1689,"width":805,"height":40},"line":61,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5349d82215ce429781233e06f9429808","type":"text","conversion_output":false,"parent_id":"94200589892b4dde9744970a83a8390e","text":"following TAVR with SAPIEN (retrospective analysis from the","text_display":" following TAVR with SAPIEN (retrospective analysis from the","confidence":1,"confidence_rate":1},{"cnt":[[1379,1729],[2171,1729],[2171,1765],[1379,1765]],"region":{"top_left_x":1378,"top_left_y":1728,"width":794,"height":38},"line":62,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"54939e2989be4bddadba19d2dbc8d948","type":"text","conversion_output":false,"parent_id":"94200589892b4dde9744970a83a8390e","text":"combined PARTNER trial and NRCA registry) was associated","text_display":" combined PARTNER trial and NRCA registry) was associated","confidence":1,"confidence_rate":1},{"cnt":[[1379,1763],[2186,1763],[2186,1800],[1379,1800]],"region":{"top_left_x":1378,"top_left_y":1763,"width":809,"height":38},"line":63,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c02c337e9abf405392e412082d3c9fd4","type":"text","conversion_output":false,"parent_id":"94200589892b4dde9744970a83a8390e","text":"with a higher rate of repeat hospitalization at 30 days and 1 year","text_display":" with a higher rate of repeat hospitalization at 30 days and 1 year","confidence":0.986328125,"confidence_rate":0.9998212342173363},{"cnt":[[103,2028],[312,2028],[312,2065],[103,2065]],"region":{"top_left_x":103,"top_left_y":2028,"width":209,"height":37},"line":64,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9f5d2f61d51249c6b46ec28bfa36f6fc","type":"page_info","conversion_output":false,"text":"Released","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1143,2032],[1605,2032],[1605,2065],[1143,2065]],"region":{"top_left_x":1142,"top_left_y":2032,"width":463,"height":33},"line":65,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c21f465d04754f0fb0a040a1394726ff","type":"page_info","conversion_output":false,"text":"REPRISE III Protocol","text_display":"","confidence":0.9990236759185791,"confidence_rate":0.9999609287234535},{"cnt":[[2282,2028],[2606,2028],[2606,2065],[2282,2065]],"region":{"top_left_x":2281,"top_left_y":2028,"width":326,"height":37},"line":66,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ce086b9a70cd45adbb0241af75f416c8","type":"page_info","conversion_output":false,"text":"90899936 AK. 4","text_display":"","confidence":0.9990234375,"confidence_rate":0.9999425287310763},{"cnt":[[799,2071],[1981,2071],[1981,2108],[799,2108]],"region":{"top_left_x":799,"top_left_y":2071,"width":1182,"height":37},"line":67,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5b566ac2df4f4408b0332ecae9ce2a90","type":"page_info","conversion_output":false,"text":"Boston Scientific Confidential. 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\\(23.9 \\%\\) vs. 18.2\\%, \\(P =0.05\\) at 1 year) but not mortality (7.5\\% vs. 5.8\\%, \\(P =0.40\\) at 30 days; \\(26.3 \\%\\) vs. \\(20.8 \\%, P =0.08\\) at 1 year) \\({ }^{100}\\). There was no severe paravalvular regurgitation and trace/trivial or no paravalvular regurgitation in \\(85.8 \\%\\) of REPRISE II subjects. Reported moderate or severe aortic regurgitation after TAVR has ranged from \\(6 \\%\\) to \\(21 \\%^{101}\\) and has been associated with increased mortality in several longitudinal registries \\({ }^{45,59,85,86}\\). \\\\\nIn summary, the observed clinical results are consistent with other TAVR studies and the PVR rates are lower... \\\\\nTable 4.14 was added.\n\\end{tabular} & \\\\\n\\hline 5. Device Description & ...both the test and the control device approved for use and commercially available at... & ...both the test and the control device. The control device in the planned size must be approved for use and commercially available at... & \\multirow[t]{3}{*}{Updated for clarity} \\\\\n\\hline 5.2 CoreValve... System (Control) & \\begin{tabular}{l}\nThe control device is the self-expanding CoreValve \\({ }^{\\circledR}\\) Transcatheter Aortic Valve Replacement System (CoreValve), which is an unapproved medical device available to Authorized Prescribers in Australia. It is introduced... \\\\\nNote 1: Every subject... both the test (Lotus) and the control (CoreValve) valve available to Authorized Prescribers at the investigational center where... \\\\\nNote 2: A center…size matrix if it is available, but…\n\\end{tabular} & \\begin{tabular}{l}\nThe control device is the commercially available self-expanding CoreValve \\({ }^{\\text {® }}\\) Transcatheter Aortic Valve Replacement System (CoreValve) that is introduced... \\\\\nNote1: Every subject... both the test (Lotus) device and the control (CoreValve) device. The CoreValve device in the planned size must be approved for use and commercially available at the investigational center where... \\\\\nNote 2: A center... size matrix if it is approved and commercially available, but...\n\\end{tabular} & \\\\\n\\hline 5.3.2 Control Device & Information is provided in the IFU supplied with the CoreValve... & Information is provided in the IFU supplied with the commercially available CoreValve... & \\\\\n\\hline 7.2 Additional Measurements & \\begin{tabular}{l}\n- Neurological status... by the following: ◯ Neurological physical exam by a neurologist or neurology fellow at discharge and 1 year \\\\\nNote 7: For subjects diagnosed with a neurological event ... a neurological physical exam (conducted by a neurologist or neurology fellow), NIHSS assessment... \\\\\n...If a subject who has not received a study device... within the first 30 days after the index...\n\\end{tabular} & \\begin{tabular}{l}\n- Neurological status... by the following: - Neurological physical exam by a neurologist, neurology fellow, neurology physician assistant, or neurology nurse practitioner at discharge and 1 year \\\\\nNote 7: For subjects diagnosed with a neurological event ... a neurological physical exam (conducted by a neurologist, neurology fellow, neurology physician assistant, or neurology nurse practitioner), NIHSS assessment...\n\\end{tabular} & Updated for clarity and a correction \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Table 27.1-3: Table of Changes for REPRISE III Protocol Version AD (Compared to REPRISE III Protocol Version AC)}\n\\begin{tabular}{|l|l|l|l|}\n\\hline Section Modified & Text as Written in REPRISE III Protocol Version AC & Text as Written in REPRISE III Protocol Version AD & Justification for Modification \\\\\n\\hline & & \\begin{tabular}{l}\n(10.6\\% vs. 5.9\\%, \\(P =0.02\\) at 30 days; \\(23.9 \\%\\) vs. 18.2\\%, \\(P =0.05\\) at 1 year) but not mortality (7.5\\% vs. 5.8\\%, \\(P =0.40\\) at 30 days; \\(26.3 \\%\\) vs. \\(20.8 \\%, P =0.08\\) at 1 year) \\({ }^{100}\\). There was no severe paravalvular regurgitation and trace/trivial or no paravalvular regurgitation in \\(85.8 \\%\\) of REPRISE II subjects. Reported moderate or severe aortic regurgitation after TAVR has ranged from \\(6 \\%\\) to \\(21 \\%^{101}\\) and has been associated with increased mortality in several longitudinal registries \\({ }^{45,59,85,86}\\). \\\\\nIn summary, the observed clinical results are consistent with other TAVR studies and the PVR rates are lower... \\\\\nTable 4.14 was added.\n\\end{tabular} & \\\\\n\\hline 5. Device Description & ...both the test and the control device approved for use and commercially available at... & ...both the test and the control device. The control device in the planned size must be approved for use and commercially available at... & \\multirow[t]{3}{*}{Updated for clarity} \\\\\n\\hline 5.2 CoreValve... System (Control) & \\begin{tabular}{l}\nThe control device is the self-expanding CoreValve \\({ }^{\\circledR}\\) Transcatheter Aortic Valve Replacement System (CoreValve), which is an unapproved medical device available to Authorized Prescribers in Australia. It is introduced... \\\\\nNote 1: Every subject... both the test (Lotus) and the control (CoreValve) valve available to Authorized Prescribers at the investigational center where... \\\\\nNote 2: A center…size matrix if it is available, but…\n\\end{tabular} & \\begin{tabular}{l}\nThe control device is the commercially available self-expanding CoreValve \\({ }^{\\text {® }}\\) Transcatheter Aortic Valve Replacement System (CoreValve) that is introduced... \\\\\nNote1: Every subject... both the test (Lotus) device and the control (CoreValve) device. The CoreValve device in the planned size must be approved for use and commercially available at the investigational center where... \\\\\nNote 2: A center... size matrix if it is approved and commercially available, but...\n\\end{tabular} & \\\\\n\\hline 5.3.2 Control Device & Information is provided in the IFU supplied with the CoreValve... & Information is provided in the IFU supplied with the commercially available CoreValve... & \\\\\n\\hline 7.2 Additional Measurements & \\begin{tabular}{l}\n- Neurological status... by the following: ◯ Neurological physical exam by a neurologist or neurology fellow at discharge and 1 year \\\\\nNote 7: For subjects diagnosed with a neurological event ... a neurological physical exam (conducted by a neurologist or neurology fellow), NIHSS assessment... \\\\\n...If a subject who has not received a study device... within the first 30 days after the index...\n\\end{tabular} & \\begin{tabular}{l}\n- Neurological status... by the following: - 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Section Modified & Text as Written in REPRISE III Protocol Version AC & Text as Written in REPRISE III Protocol Version AD & Justification for Modification \\\\\n\\hline & & ...If a subject who has not received a study device... within the first 1 year after the index… & \\\\\n\\hline 8.2 Treatment Assignment & Eligible subjects… or the self-expanding CoreValve \\({ }^{\\circledR}\\) Transcatheter Aortic Valve Replacement System (control). & Eligible subjects... or a commercially available self-expanding CoreValve \\({ }^{\\text {® }}\\) Transcatheter Aortic Valve Replacement System (control). & \\multirow[t]{2}{*}{Updated for clarity} \\\\\n\\hline 8.2.1 Treatment & The control device is the CoreValve.... & The control device is the commercially available CoreValve... & \\\\\n\\hline \\multirow[t]{2}{*}{Table 9.2-1} & IC1. Subject has... an initial AVA of \\(\\leq 1.0 cm^{2}\\) (or AVA index of \\(<0.6 cm^{2} / m ^{2}\\) ) and a mean pressure gradient \\(>40 mmHg\\) or jet velocity \\(>4.0 m / s \\ldots\\) echocardiography... & IC1. Subject has... an initial AVA of \\(\\leq 1.0 cm^{2}\\) (or AVA index of \\(\\leq 0.6 cm^{2} / m ^{2}\\) ) and a mean pressure gradient \\(\\geq 40 mmHg\\) or jet velocity \\(\\geq 4.0 m / s \\ldots\\) echocardiography and/or invasive hemodynamics. & To be consistent with approved control (CoreValve) Instructions For Use \\\\\n\\hline & IC4. • If STS <8, subject has... & \\begin{tabular}{l}\nIC4. • If STS <8, subject has... \\\\\n◯ Age \\(\\geq 90\\) years \\\\\n(Added text)\n\\end{tabular} & \\begin{tabular}{l}\nIn-hospital mortality rate of heart valve surgery in patients \\(\\geq 90\\) years is \\(>10 \\%^{*}\\), which is above the 8\\% risk set for study inclusion. \\\\\n*Assmann A. Interactive CardioVascular Thor Surg 2013;17:340. \\\\\nSpeziale G. J Thorac Cardiovasc Surg 2011;141:725. \\\\\nBridges C. J Am Coll Surg 2003:197:347.\n\\end{tabular} \\\\\n\\hline Table 9.3-1 & \\begin{tabular}{l}\nEC6. Subject has severe ( \\(\\geq 3+\\) ) aortic… \\\\\nEC11. Subject is being treated with chronic anticoagulation therapy other than warfarin. Subject requires chronic anticoagulation therapy (warfarin) and cannot tolerate concomitant therapy with either aspirin or clopidogrel.\n\\end{tabular} & \\begin{tabular}{l}\nEC6. Subject has severe (4+) aortic... \\\\\nEC11. Subject requires chronic anticoagulation therapy after the implant procedure and cannot be treated with warfarin (other anticoagulants are not permitted in the first month) for at least 1 month concomitant with either aspirin or clopidogrel. \\\\\nNote: Subjects who require chronic anticoagulation with warfarin\n\\end{tabular} & Updated for clarity \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Table 27.1-3: Table of Changes for REPRISE III Protocol Version AD (Compared to REPRISE III Protocol Version AC)}\n\\begin{tabular}{|l|l|l|l|}\n\\hline Section Modified & Text as Written in REPRISE III Protocol Version AC & Text as Written in REPRISE III Protocol Version AD & Justification for Modification \\\\\n\\hline & & ...If a subject who has not received a study device... within the first 1 year after the index… & \\\\\n\\hline 8.2 Treatment Assignment & Eligible subjects… or the self-expanding CoreValve \\({ }^{\\circledR}\\) Transcatheter Aortic Valve Replacement System (control). & Eligible subjects... or a commercially available self-expanding CoreValve \\({ }^{\\text {® }}\\) Transcatheter Aortic Valve Replacement System (control). & \\multirow[t]{2}{*}{Updated for clarity} \\\\\n\\hline 8.2.1 Treatment & The control device is the CoreValve.... & The control device is the commercially available CoreValve... & \\\\\n\\hline \\multirow[t]{2}{*}{Table 9.2-1} & IC1. Subject has... an initial AVA of \\(\\leq 1.0 cm^{2}\\) (or AVA index of \\(<0.6 cm^{2} / m ^{2}\\) ) and a mean pressure gradient \\(>40 mmHg\\) or jet velocity \\(>4.0 m / s \\ldots\\) echocardiography... & IC1. Subject has... an initial AVA of \\(\\leq 1.0 cm^{2}\\) (or AVA index of \\(\\leq 0.6 cm^{2} / m ^{2}\\) ) and a mean pressure gradient \\(\\geq 40 mmHg\\) or jet velocity \\(\\geq 4.0 m / s \\ldots\\) echocardiography and/or invasive hemodynamics. & To be consistent with approved control (CoreValve) Instructions For Use \\\\\n\\hline & IC4. • If STS <8, subject has... & \\begin{tabular}{l}\nIC4. • If STS <8, subject has... \\\\\n◯ Age \\(\\geq 90\\) years \\\\\n(Added text)\n\\end{tabular} & \\begin{tabular}{l}\nIn-hospital mortality rate of heart valve surgery in patients \\(\\geq 90\\) years is \\(>10 \\%^{*}\\), which is above the 8\\% risk set for study inclusion. \\\\\n*Assmann A. Interactive CardioVascular Thor Surg 2013;17:340. \\\\\nSpeziale G. 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Section Modified & Text as Written in REPRISE III Protocol Version AC & Text as Written in REPRISE III Protocol Version AD & Justification for Modification \\\\\n\\hline \\multirow{4}{*}{} & Note: Subjects who require chronic anticoagulation with warfarin must be able to be treated additionally with either aspirin or clopidogrel. & must be able to be treated additionally with either aspirin or elopidogrel. (text removed) & \\\\\n\\hline & EC9. Subject has echocardiographic evidence of new intracardiac mass, thrombus or vegetation or one requiring treatment. & EC9. Subject has echocardiographic evidence of new intracardiac vegetation or intraventricular or paravalvular thrombus. & Some intra-cardiac masses increase risk of TAVR complications whereas others do not; this update clarifies which should be exclusion criteria. \\\\\n\\hline & EC12. Subject has active peptic ulcer disease or gastrointestinal bleed... clinically significant bleeding diathesis or coagulopathy or will refuse transfusions. & EC12. Subject has gastrointestinal bleed... clinically significant bleeding diathesis or coagulopathy that would preclude treatment with required antiplatelet regimen, or will refuse transfusions. & Definition of active peptic ulcer disease is considered ambiguous by some centers (i.e., are subjects who are well controlled on medical therapy considered to have the active disease). 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Section Modified & Text as Written in REPRISE III Protocol Version AC & Text as Written in REPRISE III Protocol Version AD & Justification for Modification \\\\\n\\hline \\multirow[t]{3}{*}{Table 11.1-1} & \\begin{tabular}{l}\nb: All follow-up dates will be calculated from the date of the index procedure. Visits... \\\\\nd: Neurological physical exam... neurologist or neurology fellow. NIHSS...performed by certified personnel... \\\\\n...If a subject who has not received a study device... within the first 30 days after the index...\n\\end{tabular} & \\begin{tabular}{l}\nb: All follow-up dates will be calculated from the date of the (attempted) index procedure (or randomization in randomized subjects where no implant is attempted). Visits... \\\\\nd: Neurological physical exam... neurologist, neurology fellow, neurology physician assistant, or neurology nurse practitioner. NIHSS...performed by a neurology professional or certified personnel... \\\\\n...If a subject who has not received a study device... within the first 1 year after the index...\n\\end{tabular} & Updated for clarity and a correction \\\\\n\\hline & \\begin{tabular}{l}\ne: All baseline and post-procedure 12-lead ...Lotus Valve insertion. \\\\\nBaseline column of the 12-lead \\(ECG ^{ e }\\) row has the following: X Procedure column of the 12-lead ECG \\({ }^{ e }\\) row has the following: \\(X ^{ e }\\)\n\\end{tabular} & \\begin{tabular}{l}\ne: All screening and post-procedure 12-lead ...study valve insertion (12-lead ECG is not required during the procedure). \\\\\nRemoved from the Baseline column of the 12-lead \\(ECG ^{ e }\\) row the following: X \\\\\nRemoved from the Procedure column of the 12-lead ECG \\({ }^{\\text {e }}\\) row the following: \\(X ^{ e }\\) \\\\\nAdded a new row labeled \"Heart rhythm strip \\({ }^{\\text {e\" }}\\) which has the following in the Procedure column: \\(X ^{ e }\\)\n\\end{tabular} & Updated for clarity \\\\\n\\hline & \\begin{tabular}{l}\ng: Consists of STS score (v2.73), euroSCORE II... \\\\\ni: ...on the pre-BAV echocardiographic data.\n\\end{tabular} & \\begin{tabular}{l}\ng: Consists of STS score (v2.73), euroSCORE II... 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Visits... \\\\\nd: Neurological physical exam... neurologist or neurology fellow. NIHSS...performed by certified personnel... \\\\\n...If a subject who has not received a study device... within the first 30 days after the index...\n\\end{tabular} & \\begin{tabular}{l}\nb: All follow-up dates will be calculated from the date of the (attempted) index procedure (or randomization in randomized subjects where no implant is attempted). Visits... \\\\\nd: Neurological physical exam... neurologist, neurology fellow, neurology physician assistant, or neurology nurse practitioner. 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(removed version number) \\\\\ni: ...on the pre-BAV echocardiographic data. In such cases, the most recent echocardiogram done prior to the index procedure (even if after BAV) must be submitted to the Echocardiography Core Laboratory to be included in the baseline data.\n\\end{tabular} & \\begin{tabular}{l}\ng: To allow for updated STS score calculator \\\\\ni: Updated for clarity\n\\end{tabular} \\\\\n\\hline 11.4 Screening Assessments & \\begin{tabular}{l}\n- 12-lead electrocardiogram (ECG) at screening and/or baseline must... \\\\\n◯ Risk assessments: STS Score (2.73), euroSCORE II...\n\\end{tabular} & \\begin{tabular}{l}\n◯ 12-lead electrocardiogram (ECG) at screening must... \\\\\n◯ Risk assessments: STS Score (2.73), euroSCORE II... (removed version number)\n\\end{tabular} & \\multirow[t]{2}{*}{Updated for clarity} \\\\\n\\hline & \\begin{tabular}{l}\n- Frailty, disability, and comorbidity assessments (collected prospectively) \\\\\nO Nutritional assessment \\\\\n□ Albumin \\\\\nO Body Mass Index...\n\\end{tabular} & \\begin{tabular}{l}\n- Frailty, disability, and comorbidity assessments (collected prospectively) \\\\\nO Nutritional assessment(removed the 2 bullets) \\\\\nAlbumin \\\\\nO Body Mass Index...\n\\end{tabular} & \\\\\n\\hline\n\\end{tabular}\n\\end{table}","confidence":0.41245090268512286,"confidence_rate":0.9988266365096897},{"cnt":[[255,399],[474,399],[474,1783],[255,1783]],"region":{"top_left_x":254,"top_left_y":399,"width":220,"height":1384},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"85dc2b3f803843ab843b463510cf7438","type":"table_column","conversion_output":false,"parent_id":"08e3b15a0db648a3b13ca482f13646f7","text":"","text_display":""},{"cnt":[[504,399],[1348,399],[1348,1783],[504,1783]],"region":{"top_left_x":503,"top_left_y":399,"width":846,"height":1384},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"68c9f59cb6e34c648cadd9c7f796ee02","type":"table_column","conversion_output":false,"parent_id":"08e3b15a0db648a3b13ca482f13646f7","text":"","text_display":""},{"cnt":[[1363,399],[2210,398],[2212,1783],[1365,1784]],"region":{"top_left_x":1362,"top_left_y":397,"width":851,"height":1388},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9eff76e80c554d8db95be03620c82dee","type":"table_column","conversion_output":false,"parent_id":"08e3b15a0db648a3b13ca482f13646f7","text":"","text_display":""},{"cnt":[[2228,399],[2524,399],[2524,1783],[2228,1783]],"region":{"top_left_x":2227,"top_left_y":399,"width":298,"height":1384},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"dc0cf8e287ea49a1928646595cdab173","type":"table_column","conversion_output":false,"parent_id":"08e3b15a0db648a3b13ca482f13646f7","text":"","text_display":""},{"cnt":[[244,403],[2544,403],[2544,488],[244,488]],"region":{"top_left_x":244,"top_left_y":403,"width":2300,"height":85},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ea5aead3d835436cbb55ce994609075d","type":"table_row","conversion_output":false,"parent_id":"08e3b15a0db648a3b13ca482f13646f7","text":"","text_display":""},{"cnt":[[244,492],[2542,492],[2542,841],[244,841]],"region":{"top_left_x":244,"top_left_y":492,"width":2298,"height":349},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6e9ac09444e04418a65496c968d92af4","type":"table_row","conversion_output":false,"parent_id":"08e3b15a0db648a3b13ca482f13646f7","text":"","text_display":""},{"cnt":[[244,841],[2542,841],[2542,1174],[244,1174]],"region":{"top_left_x":244,"top_left_y":840,"width":2298,"height":335},"line":15,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3c83b39fb3f9424f97a413d8bee23a0c","type":"table_row","conversion_output":false,"parent_id":"08e3b15a0db648a3b13ca482f13646f7","text":"","text_display":""},{"cnt":[[244,1179],[2542,1179],[2542,1417],[244,1417]],"region":{"top_left_x":244,"top_left_y":1178,"width":2298,"height":239},"line":16,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f9432865456249cbb98322399dbd08e7","type":"table_row","conversion_output":false,"parent_id":"08e3b15a0db648a3b13ca482f13646f7","text":"","text_display":""},{"cnt":[[244,1421],[2542,1421],[2542,1551],[244,1551]],"region":{"top_left_x":244,"top_left_y":1421,"width":2298,"height":131},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3566b3789faf4c9ba1d394754e560326","type":"table_row","conversion_output":false,"parent_id":"08e3b15a0db648a3b13ca482f13646f7","text":"","text_display":""},{"cnt":[[244,1553],[2542,1553],[2542,1783],[244,1783]],"region":{"top_left_x":244,"top_left_y":1553,"width":2298,"height":230},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5047f5194a314d73a3a938db1a52c5dc","type":"table_row","conversion_output":false,"parent_id":"08e3b15a0db648a3b13ca482f13646f7","text":"","text_display":""},{"cnt":[[263,412],[396,412],[396,479],[263,479]],"region":{"top_left_x":263,"top_left_y":411,"width":133,"height":69},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"44772b255a2f43a5aebd393a8a6ee89a","type":"complex_cell","conversion_output":false,"parent_id":"08e3b15a0db648a3b13ca482f13646f7","children_ids":["4f7ab61c1f00462d92fa0aef78ae6494","ff8302199b66497fb202cc5cf9fcc615"],"text":"Section 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(including recommended rotational angiography of the valve frame) must be performed... \\\\\n- Heart rhythm… recorded\n\\end{tabular} & \\begin{tabular}{l}\n8) A final ... (including recommended rotational angiography of the valve frame, required only for Lotus) must be performed... \\\\\n- Heart rhythm… recorded (12-lead ECG is not required)\n\\end{tabular} & The rotational angiography is required for Lotus to allow comparison with required annual assessment; updated heart rhythm bullet for clarity. \\\\\n\\hline 11.8 PostProcedure & - If a subject requires chronic anticoagulation with warfarin (other anticoagulants are not permitted), either clopidogrel or aspirin is required after the implant procedure in addition to the anticoagulant therapy (but both aspirin and clopidogrel are not required). Subjects treated with warfarin should not be treated with a \\(P 2 Y _{12}\\) inhibitor other than clopidogrel. & - If a subject requires chronic anticoagulation, either clopidogrel or aspirin is required after the implant procedure in addition to the anticoagulant therapy (but both aspirin and clopidogrel are not required). The subject must be treated with warfarin (other anticoagulants are not permitted in the first month) and either clopidogrel (other \\(P 2 Y _{12}\\) inhibitors are not permitted in combination with warfarin) or aspirin for at least 1 month. After 1 month, subjects requiring chronic anticoagulation may be switched from warfarin to a new oral anticoagulant (NOAC) at the discretion of the treating physician. 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\\multicolumn{4}{|l|}{Table 27.1-4: Table of Changes for REPRISE III Protocol Version AE (Compared to REPRISE III Protocol Version AD)} \\\\\n\\hline Section Modified & Text as Written in REPRISE III Protocol Version AD & Text as Written in REPRISE III Protocol Version AE & Justification for Modification \\\\\n\\hline Page 2 & Current Version: 23-Apr-2015 & Current Version: 19-Aug-2015 Updated Table of Revision History & Updated for clarity \\\\\n\\hline 2. Protocol Synopsis, Test Devices and Sizes & The Lotus Valve System consisting of two... Devices sizes include \\(23 mm, 25 mm\\), and 27 mm diameter. & The Lotus Valve System consisting of two... Devices sizes include \\(21 mm, 23 mm, 25 mm\\), and 27 mm diameter. & \\multirow[t]{2}{*}{Addition of the 21 mm Lotus Valve to the test matrix and the 23 mm CoreValve Evolut to the control matrix} \\\\\n\\hline 2. 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\\multicolumn{4}{|l|}{Table 27.1-4: Table of Changes for REPRISE III Protocol Version AE (Compared to REPRISE III Protocol Version AD)} \\\\\n\\hline Section Modified & Text as Written in REPRISE III Protocol Version AD & Text as Written in REPRISE III Protocol Version AE & Justification for Modification \\\\\n\\hline 5.1 Lotus Valve System... (Test) & Device sizes include \\(23 mm, 25 mm\\), and 27 mm diameter. & Device sizes include \\(21 mm, 23 mm, 25 mm\\), and 27 mm diameter. & \\multirow[t]{5}{*}{Addition of the 21 mm Lotus Valve to the test matrix and the 23 mm CoreValve Evolut to the control matrix} \\\\\n\\hline 5.1.1 Lotus Valve & The device is designed to produce a final diameter of 23 mm , 25 mm , or \\(27 mm . .\\). The frame height of all valve sizes in the deployed state is approximately 19 mm . & The device is designed to produce a final diameter of 21 mm , \\(23 mm, 25 mm\\), or \\(27 mm \\ldots\\) In the deployed state, the frame height of the 21 mm valve is approximately 15 mm ; the frame height of the three larger valve sizes is approximately 19 mm . & \\\\\n\\hline 5.1.3 Lotus Introducer Set & The Lotus Introducer is suitable for use in subjects requiring the 23 mm valve with femoral artery lumen diameter \\(\\geq 6.0 mm\\) or... & The Lotus Introducer is suitable for use in subjects requiring the 21 mm or 23 mm valve with femoral artery lumen diameter \\(\\geq 6.0 mm\\) or... & \\\\\n\\hline 5.2 CoreValve ...System (Control) & Devices sizes include \\(26 mm, 29 mm\\), and 31 mm diameter. & Devices sizes include the CoreValve \\({ }^{\\circledR}\\) Evolut \\({ }^{\\text {TM }} 23 mm\\) diameter and the CoreValve \\(26 mm, 29 mm\\), and 31 mm diameter. & \\\\\n\\hline 5.3.2 Control Device & Information is provided in the IFU supplied with the commercially available CoreValve... & Information is provided in the IFU supplied with the commercially available CoreValve and CoreValve \\({ }^{\\circledR}\\) Evolut \\({ }^{ TM } 23 mm . .\\). & \\\\\n\\hline Table 9.2-1 & IC2. Subject has a documented aortic annulus size of \\(\\geq 20 mm\\) and \\(\\leq 27 mm\\)... & IC2. Subject has a documented aortic annulus size of \\(\\geq 18 mm\\) and \\(\\leq 27 mm\\)... & Smaller valve size can be used with smaller annulus sizes \\\\\n\\hline 11.7.2.2 Preparing... & - Device size ( \\(23 mm, 25 mm\\), or 27 mm ) and model & - Device size ( \\(21 mm, 23 mm, 25 mm\\), or 27 mm ) and model & Addition of the 21 mm Lotus Valve to the test matrix \\\\\n\\hline 27 Appendices & - & Added Section 27.1-4 and Table 27.1-4 & List changes made. \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|l|l|}\n\\hline \\multicolumn{4}{|l|}{Table 27.1-4: Table of Changes for REPRISE III Protocol Version AE (Compared to REPRISE III Protocol Version AD)} \\\\\n\\hline Section Modified & Text as Written in REPRISE III Protocol Version AD & Text as Written in REPRISE III Protocol Version AE & Justification for Modification \\\\\n\\hline 5.1 Lotus Valve System... (Test) & Device sizes include \\(23 mm, 25 mm\\), and 27 mm diameter. & Device sizes include \\(21 mm, 23 mm, 25 mm\\), and 27 mm diameter. & \\multirow[t]{5}{*}{Addition of the 21 mm Lotus Valve to the test matrix and the 23 mm CoreValve Evolut to the control matrix} \\\\\n\\hline 5.1.1 Lotus Valve & The device is designed to produce a final diameter of 23 mm , 25 mm , or \\(27 mm . .\\). The frame height of all valve sizes in the deployed state is approximately 19 mm . & The device is designed to produce a final diameter of 21 mm , \\(23 mm, 25 mm\\), or \\(27 mm \\ldots\\) In the deployed state, the frame height of the 21 mm valve is approximately 15 mm ; the frame height of the three larger valve sizes is approximately 19 mm . & \\\\\n\\hline 5.1.3 Lotus Introducer Set & The Lotus Introducer is suitable for use in subjects requiring the 23 mm valve with femoral artery lumen diameter \\(\\geq 6.0 mm\\) or... & The Lotus Introducer is suitable for use in subjects requiring the 21 mm or 23 mm valve with femoral artery lumen diameter \\(\\geq 6.0 mm\\) or... & \\\\\n\\hline 5.2 CoreValve ...System (Control) & Devices sizes include \\(26 mm, 29 mm\\), and 31 mm diameter. & Devices sizes include the CoreValve \\({ }^{\\circledR}\\) Evolut \\({ }^{\\text {TM }} 23 mm\\) diameter and the CoreValve \\(26 mm, 29 mm\\), and 31 mm diameter. & \\\\\n\\hline 5.3.2 Control Device & Information is provided in the IFU supplied with the commercially available CoreValve... & Information is provided in the IFU supplied with the commercially available CoreValve and CoreValve \\({ }^{\\circledR}\\) Evolut \\({ }^{ TM } 23 mm . .\\). & \\\\\n\\hline Table 9.2-1 & IC2. 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\\multicolumn{4}{|l|}{Table 27.1-5: Table of Changes for REPRISE III Protocol Version AF (Compared to REPRISE III Protocol Version AE)} \\\\\n\\hline Section Modified & Text as Written in REPRISE III Protocol Version AE & Text as Written in REPRISE III Protocol Version AF & Justification for Modification \\\\\n\\hline & \\begin{tabular}{l}\nEuropean Headquarters, Paris \\\\\n55 Av. des Champs Pierreux, TSA 51101 \\\\\n92729 Nanterre Cedex, France\n\\end{tabular} & \\begin{tabular}{l}\nBallybrit Business Park \\\\\nGalway, Ireland\n\\end{tabular} & \\\\\n\\hline Page 2 & Current Version: 19-Aug-2015 & \\begin{tabular}{l}\nCurrent Version: 07-Dec-2015 \\\\\nUpdated Table of Revision History\n\\end{tabular} & \\multirow{2}{*}{Updated for clarity} \\\\\n\\hline 2. 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There will be up to 1032 subjects in REPRISE III... and randomized. & Subjects will be enrolled at up to 60 centers in the United States, Canada, Western Europe, and Australia. There will be up to 1052 subjects in REPRISE III... and randomized. Up to 20 subjects will be enrolled in the Lotus 21 mm Nested Registry. & \\\\\n\\hline 2. Protocol Synopsis Primary & \\begin{tabular}{l}\nPrimary Safety Endpoint: ... at 30 days. \\\\\nPrimary Effectiveness Endpoint:... at 1 year\n\\end{tabular} & \\begin{tabular}{l}\nPrimary Safety Endpoint: ... at 30 days. \\\\\nPrimary Effectiveness Endpoint:... at 1 year \\\\\nPowered statistical analyses for the primary safety endpoint and\n\\end{tabular} & Updated for clarity \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|l|l|}\n\\hline \\multicolumn{4}{|l|}{Table 27.1-5: Table of Changes for REPRISE III Protocol Version AF (Compared to REPRISE III Protocol Version AE)} \\\\\n\\hline Section Modified & Text as Written in REPRISE III Protocol Version AE & Text as Written in REPRISE III Protocol Version AF & Justification for Modification \\\\\n\\hline & \\begin{tabular}{l}\nEuropean Headquarters, Paris \\\\\n55 Av. des Champs Pierreux, TSA 51101 \\\\\n92729 Nanterre Cedex, France\n\\end{tabular} & \\begin{tabular}{l}\nBallybrit Business Park \\\\\nGalway, Ireland\n\\end{tabular} & \\\\\n\\hline Page 2 & Current Version: 19-Aug-2015 & \\begin{tabular}{l}\nCurrent Version: 07-Dec-2015 \\\\\nUpdated Table of Revision History\n\\end{tabular} & \\multirow{2}{*}{Updated for clarity} \\\\\n\\hline 2. 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Protocol Synopsis Secondary Endpoint & Moderate or greater paravalvular aortic regurgitation (based on core lab assessment) at 1 year & \\begin{tabular}{l}\nModerate or greater paravalvular aortic regurgitation (based on core lab assessment) at 1 year \\\\\nPowered statistical analysis for the secondary endpoint will be carried out on the randomized cohort.\n\\end{tabular} & \\\\\n\\hline 2. Protocol Synopsis Inclusion... & IC2. Subject... and is deemed treatable with an available size of both test and control device. & IC2. Subject... and, for the randomized cohort, is deemed treatable with an available size of both test and control device. & \\\\\n\\hline 2. Protocol Synopsis Analysis Sets & \\begin{tabular}{l}\nAs-Treated: This population... \\\\\nFor all analysis sets... first valve received.\n\\end{tabular} & \\begin{tabular}{l}\nAnalysis sets for the randomized cohort are listed below. As-Treated: This population... \\\\\nFor all randomized cohort analysis sets... first valve received. Among the roll-in and the Lotus 21 mm Nested Registry cohorts, for ITT analyses all subjects who sign an Informed Consent Form and are enrolled in the study will be included in the analysis sample, regardless of whether the study device was implanted. The As-Treated population is the same as the Implanted population for these two cohorts and includes all subjects who sign an Informed Consent Form and are implanted with the Lotus valve.\n\\end{tabular} & Updated for clarity and to include the Lotus 21 mm Nested Registry cohort. \\\\\n\\hline 4.0 Introduction & Additional device information can be found in found in Section 5. & Additional device information can be found in Section 5. Study subjects will be entered into the roll-in cohort, randomized (test versus control) cohort, or a single-arm, non-randomized, nested registry cohort of subjects who receive the 21 mm Lotus Valve (Lotus 21 mm Nested Registry). Additional information on study design can be found in Section 8. & Updated for clarity \\\\\n\\hline 4.1.2 REPRISE I Study & To date, data are available through 2 years... There were no additional MACCE events beyond the primary endpoint. The 2year… was \\(3 / 11 \\ldots\\) resolved… While… baseline and 2 years… The mean… at 2 years. Paravalvular… at 2 years… & To date, data are available through 3 years... There were no additional MACCE events beyond the primary endpoint through 2 years and 1 noncardiovascular death in the interval between 2 and 3 years. The 3 -year… was \\(4 / 11 \\ldots\\) resolved, and there was 1 noncardiovascular death due to uncontrolled sepsis. ... 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Study subjects will be entered into the roll-in cohort, randomized (test versus control) cohort, or a single-arm, non-randomized, nested registry cohort of subjects who receive the 21 mm Lotus Valve (Lotus 21 mm Nested Registry). Additional information on study design can be found in Section 8. & Updated for clarity \\\\\n\\hline 4.1.2 REPRISE I Study & To date, data are available through 2 years... There were no additional MACCE events beyond the primary endpoint. The 2year… was \\(3 / 11 \\ldots\\) resolved… While… baseline and 2 years… The mean… at 2 years. Paravalvular… at 2 years… & To date, data are available through 3 years... There were no additional MACCE events beyond the primary endpoint through 2 years and 1 noncardiovascular death in the interval between 2 and 3 years. The 3 -year… was \\(4 / 11 \\ldots\\) resolved, and there was 1 noncardiovascular death due to uncontrolled sepsis. ... 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As-Treated: This population... \\\\\nFor all randomized cohort analysis sets... first valve received. Among the roll-in and the Lotus 21 mm Nested Registry cohorts, for ITT analyses all subjects who sign an Informed Consent Form and are enrolled in the study will be included in the analysis sample, regardless of whether the study device was implanted. The As-Treated population is the same as the Implanted population for these two cohorts and includes all subjects who sign an Informed Consent Form and are implanted with the Lotus valve.\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nAnalysis sets for the randomized cohort are listed below. As-Treated: This population... \\\\\nFor all randomized cohort analysis sets... first valve received. Among the roll-in and the Lotus 21 mm Nested Registry cohorts, for ITT analyses all subjects who sign an Informed Consent Form and are enrolled in the study will be included in the analysis sample, regardless of whether the study device was implanted. The As-Treated population is the same as the Implanted population for these two cohorts and includes all subjects who sign an Informed Consent Form and are implanted with the Lotus valve.\n\\end{tabular}","cell_row":5,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":0.96240234375,"confidence_rate":0.9999412272801731},{"cnt":[[1379,863],[2095,863],[2095,904],[1379,904]],"region":{"top_left_x":1378,"top_left_y":863,"width":718,"height":42},"line":70,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6ee695624cf0468588a3f3047ca1a894","type":"text","conversion_output":false,"parent_id":"613c0fc7464b479795b69bd763a880b6","text":"Analysis sets for the randomized cohort are listed below.","text_display":"Analysis sets for the randomized cohort are listed 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regardless of whether the study device was implanted.","text_display":" sample, regardless of whether the study device was implanted.","confidence":1,"confidence_rate":1},{"cnt":[[1379,1127],[2087,1127],[2087,1164],[1379,1164]],"region":{"top_left_x":1378,"top_left_y":1127,"width":709,"height":38},"line":77,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2a3a1e1fc3114811978dd6507794fc71","type":"text","conversion_output":false,"parent_id":"613c0fc7464b479795b69bd763a880b6","text":"The As-Treated population is the same as the Implanted","text_display":" The As-Treated population is the same as the Implanted","confidence":1,"confidence_rate":1},{"cnt":[[1379,1164],[2165,1164],[2165,1203],[1379,1203]],"region":{"top_left_x":1378,"top_left_y":1164,"width":787,"height":40},"line":78,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0be9994e07f84366ba4da3b9f67d2dbb","type":"text","conversion_output":false,"parent_id":"613c0fc7464b479795b69bd763a880b6","text":"population for these two cohorts and includes all subjects who","text_display":" population for these two cohorts and includes all subjects who","confidence":0.99951171875,"confidence_rate":0.9999927104668955},{"cnt":[[1379,1201],[2204,1201],[2204,1238],[1379,1238]],"region":{"top_left_x":1378,"top_left_y":1200,"width":826,"height":38},"line":79,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5a11267b83cd491a873083d8921c036a","type":"text","conversion_output":false,"parent_id":"613c0fc7464b479795b69bd763a880b6","text":"sign an Informed Consent Form and are implanted with the 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information can be found in found in Section 5.","text_display":"Additional device information can be found in found in Section 5.","cell_row":6,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[515,1279],[1316,1279],[1316,1316],[515,1316]],"region":{"top_left_x":514,"top_left_y":1278,"width":802,"height":38},"line":88,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2f01fb21d44040cb926c1e9a2a935e6f","type":"text","conversion_output":false,"parent_id":"e6abef9699934306a532e17fee32767e","text":"Additional device information can be found in found in Section","text_display":"Additional device information can be found in found in 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Study subjects will be entered into the roll-in cohort, randomized (test versus control) cohort, or a single-arm, non-randomized, nested registry cohort of subjects who receive the 21 mm Lotus Valve (Lotus 21 mm Nested Registry). Additional information on study design can be found in Section 8.","text_display":"Additional device information can be found in Section 5. Study subjects will be entered into the roll-in cohort, randomized (test versus control) cohort, or a single-arm, non-randomized, nested registry cohort of subjects who receive the 21 mm Lotus Valve (Lotus 21 mm Nested Registry). 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30 day mean aortic valve pressure gradient was... Table 4.1-3 shows 6-month and 1-year clinical... \\\\\nAt 1 year, mortality was \\(11.0 \\%\\) and the disabling stroke rate was \\(3.5 \\%\\). The low paravalvular aortic regurgitation rate observed at 30 days was maintained at 1 year as most subjects ( \\(86 \\%\\) ) had none/trivial paravalvular aortic regurgitation; there was no severe paravalvular regurgitation.. \\\\\nTable 4.1-3 with 6-month and 1-year data for the REPRISE II main cohort \\(( N =120)\\). \\\\\nThe REPRISE II study was subsequently expanded... plus a testing margin of \\(6.2 \\%\\) ). \\\\\nTable 4.14 shows device performance endpoints, clinical outcomes, and echocardiographic outcomes through 30 days for the full cohort \\(( N =250)\\). Outcomes in the full cohort ...several longitudinal registries. \\\\\nTable 4.1-4 with 30-day data for the REPRISE II full cohort \\(( N =250)\\).\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nThe 30 day mean aortic valve pressure gradient was... Table 4.1-3 shows 6-month and 1-year clinical... \\\\\nAt 1 year, mortality was \\(11.0 \\%\\) and the disabling stroke rate was \\(3.5 \\%\\). The low paravalvular aortic regurgitation rate observed at 30 days was maintained at 1 year as most subjects ( \\(86 \\%\\) ) had none/trivial paravalvular aortic regurgitation; there was no severe paravalvular regurgitation.. \\\\\nTable 4.1-3 with 6-month and 1-year data for the REPRISE II main cohort \\(( N =120)\\). \\\\\nThe REPRISE II study was subsequently expanded... plus a testing margin of \\(6.2 \\%\\) ). \\\\\nTable 4.14 shows device performance endpoints, clinical outcomes, and echocardiographic outcomes through 30 days for the full cohort \\(( N =250)\\). Outcomes in the full cohort ...several longitudinal registries. \\\\\nTable 4.1-4 with 30-day data for the REPRISE II full cohort \\(( N =250)\\).\n\\end{tabular}","cell_row":3,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.7099609375,"confidence_rate":0.9994359407121872},{"cnt":[[515,582],[1203,582],[1203,618],[515,618]],"region":{"top_left_x":514,"top_left_y":581,"width":690,"height":38},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8729b3fc3e60438d8cea42d0557df535","type":"text","conversion_output":false,"parent_id":"b59ed67605c146809ea41593c8a4cecd","text":"The 30 day mean aortic valve pressure gradient was...","text_display":"The 30 day mean aortic valve pressure gradient was...","confidence":0.99267578125,"confidence_rate":0.9998794962360626},{"cnt":[[517,616],[1136,616],[1136,653],[517,653]],"region":{"top_left_x":516,"top_left_y":616,"width":621,"height":37},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9235b78e279444c78c482b999926099d","type":"text","conversion_output":false,"parent_id":"b59ed67605c146809ea41593c8a4cecd","text":"Table 4.1-3 shows 6-month and 1-year clinical...","text_display":" Table 4.1-3 shows 6-month and 1-year clinical...","confidence":0.9453389644622803,"confidence_rate":0.9989399636839613},{"cnt":[[515,655],[1329,655],[1329,696],[515,696]],"region":{"top_left_x":514,"top_left_y":655,"width":815,"height":42},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"803fa8ac91f645959a6f327d4ab1238e","type":"text","conversion_output":false,"parent_id":"b59ed67605c146809ea41593c8a4cecd","text":"At 1 year, mortality was \\(11.0 \\%\\) and the disabling stroke rate was","text_display":"\nAt 1 year, mortality was \\(11.0 \\%\\) and the disabling stroke rate was","confidence":1,"confidence_rate":1},{"cnt":[[515,690],[1327,690],[1327,731],[515,731]],"region":{"top_left_x":514,"top_left_y":689,"width":813,"height":42},"line":39,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f658791b571e4aa58021a5470999096e","type":"text","conversion_output":false,"parent_id":"b59ed67605c146809ea41593c8a4cecd","text":"\\(3.5 \\%\\). The low paravalvular aortic regurgitation rate observed at","text_display":" \\(3.5 \\%\\). The low paravalvular aortic regurgitation rate observed at","confidence":1,"confidence_rate":1},{"cnt":[[517,729],[1290,729],[1290,766],[517,766]],"region":{"top_left_x":516,"top_left_y":728,"width":774,"height":38},"line":40,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8169ecb2620c4871a3b918f9147de675","type":"text","conversion_output":false,"parent_id":"b59ed67605c146809ea41593c8a4cecd","text":"30 days was maintained at 1 year as most subjects ( \\(86 \\%\\) ) had","text_display":" 30 days was maintained at 1 year as most subjects ( \\(86 \\%\\) ) had","confidence":0.99853515625,"confidence_rate":0.9999793534852197},{"cnt":[[517,763],[1342,763],[1342,802],[517,802]],"region":{"top_left_x":516,"top_left_y":763,"width":826,"height":40},"line":41,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bb34f68a857349a38ca38e0f96019950","type":"text","conversion_output":false,"parent_id":"b59ed67605c146809ea41593c8a4cecd","text":"none/trivial paravalvular aortic regurgitation; there was no severe","text_display":" none/trivial paravalvular aortic regurgitation; there was no severe","confidence":1,"confidence_rate":1},{"cnt":[[515,800],[863,800],[863,839],[515,839]],"region":{"top_left_x":514,"top_left_y":800,"width":350,"height":40},"line":42,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c2a5dac4fb254cd5a28ebfa9c1fdf9b0","type":"text","conversion_output":false,"parent_id":"b59ed67605c146809ea41593c8a4cecd","text":"paravalvular regurgitation..","text_display":" paravalvular regurgitation..","confidence":1,"confidence_rate":1},{"cnt":[[515,878],[1299,878],[1299,917],[515,917]],"region":{"top_left_x":514,"top_left_y":878,"width":785,"height":40},"line":43,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5a245f02d944419c912c5c65e2bfa49b","type":"text","conversion_output":false,"parent_id":"b59ed67605c146809ea41593c8a4cecd","text":"Table 4.1-3 with 6-month and 1-year data for the REPRISE II","text_display":"\nTable 4.1-3 with 6-month and 1-year data for the REPRISE II","confidence":0.9287455081939697,"confidence_rate":0.9988456586501205},{"cnt":[[517,915],[796,915],[796,952],[517,952]],"region":{"top_left_x":516,"top_left_y":915,"width":281,"height":37},"line":44,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4a0bc7bb1145409e8904b6bc9200b18a","type":"text","conversion_output":false,"parent_id":"b59ed67605c146809ea41593c8a4cecd","text":"main cohort \\(( N =120)\\).","text_display":" main cohort \\(( N =120)\\).","confidence":0.9819836616516113,"confidence_rate":0.9994320173446462},{"cnt":[[515,993],[1279,993],[1279,1030],[515,1030]],"region":{"top_left_x":514,"top_left_y":992,"width":766,"height":38},"line":45,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"beb9553651e6442c858b5f5ed5ebb3e5","type":"text","conversion_output":false,"parent_id":"b59ed67605c146809ea41593c8a4cecd","text":"The REPRISE II study was subsequently expanded... plus a","text_display":"\nThe REPRISE II study was subsequently expanded... plus a","confidence":0.7099609375,"confidence_rate":0.9944002402512723},{"cnt":[[517,1028],[827,1028],[827,1069],[517,1069]],"region":{"top_left_x":516,"top_left_y":1027,"width":311,"height":42},"line":46,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"657c8ddc903742a08ab5b908ae1fde05","type":"text","conversion_output":false,"parent_id":"b59ed67605c146809ea41593c8a4cecd","text":"testing margin of \\(6.2 \\%\\) ).","text_display":" testing margin of \\(6.2 \\%\\) ).","confidence":0.9990234375,"confidence_rate":0.9999703931762353},{"cnt":[[517,1106],[1242,1106],[1242,1147],[517,1147]],"region":{"top_left_x":516,"top_left_y":1105,"width":727,"height":42},"line":47,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"521dd75226d049b188964085e89821c6","type":"text","conversion_output":false,"parent_id":"b59ed67605c146809ea41593c8a4cecd","text":"Table 4.14 shows device performance endpoints, clinical","text_display":"\nTable 4.14 shows device performance endpoints, clinical","confidence":0.99951171875,"confidence_rate":0.9999922476411908},{"cnt":[[517,1145],[1325,1145],[1325,1181],[517,1181]],"region":{"top_left_x":516,"top_left_y":1144,"width":809,"height":38},"line":48,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6f46ac67dcdb41c2b22a6e38209452b4","type":"text","conversion_output":false,"parent_id":"b59ed67605c146809ea41593c8a4cecd","text":"outcomes, and echocardiographic outcomes through 30 days for","text_display":" outcomes, and echocardiographic outcomes through 30 days for","confidence":1,"confidence_rate":1},{"cnt":[[515,1179],[1303,1179],[1303,1216],[515,1216]],"region":{"top_left_x":514,"top_left_y":1179,"width":789,"height":38},"line":49,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3669f75de6934cb9b7ee8cf505864ae1","type":"text","conversion_output":false,"parent_id":"b59ed67605c146809ea41593c8a4cecd","text":"the full cohort \\(( N =250)\\). Outcomes in the full cohort ...several","text_display":" the full cohort \\(( N =250)\\). Outcomes in the full cohort ...several","confidence":0.9805466165141752,"confidence_rate":0.9997380997570414},{"cnt":[[517,1216],[805,1216],[805,1255],[517,1255]],"region":{"top_left_x":516,"top_left_y":1216,"width":289,"height":39},"line":50,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"48d312f6ece1479bb168e0cdaa782f01","type":"text","conversion_output":false,"parent_id":"b59ed67605c146809ea41593c8a4cecd","text":"longitudinal registries.","text_display":" longitudinal registries.","confidence":1,"confidence_rate":1},{"cnt":[[515,1331],[1277,1331],[1277,1372],[515,1372]],"region":{"top_left_x":514,"top_left_y":1330,"width":763,"height":42},"line":51,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e96d42d15a0a42ca9dd994624ac81f37","type":"text","conversion_output":false,"parent_id":"b59ed67605c146809ea41593c8a4cecd","text":"Table 4.1-4 with 30-day data for the REPRISE II full cohort","text_display":"\nTable 4.1-4 with 30-day data for the REPRISE II full cohort","confidence":0.9990234375,"confidence_rate":0.9999847338720312},{"cnt":[[517,1370],[638,1370],[638,1407],[517,1407]],"region":{"top_left_x":516,"top_left_y":1369,"width":123,"height":38},"line":52,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"19abe98a7d8541d9a82d0ae5d4536204","type":"text","conversion_output":false,"parent_id":"b59ed67605c146809ea41593c8a4cecd","text":"\\(( N =250)\\).","text_display":" \\(( N =250)\\).","confidence":0.98828125,"confidence_rate":0.9992635240971027},{"cnt":[[1372,577],[2210,577],[2210,1697],[1372,1697]],"region":{"top_left_x":1372,"top_left_y":577,"width":839,"height":1120},"line":53,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ff96fd4bdff740a197a02a9dbe1c795a","type":"complex_cell","conversion_output":false,"parent_id":"22cb446abf664f9997cebb9b34ffa3c5","children_ids":["e1399308666e4bd59cc69936925ca037","2f7bf4218b874a08bd67059ce6669057","4db88ee0f47c463d98cb5f20b6608cb1","da42c17e0ffe40bcb66b5d75a1766005","47998e31b83a44bd884af48cdc2d693a","bf4e4f6bac6041d0a6c3d435a35a97df","ac0ac992e58041b58830f7087e23bdc1","b956611a29cd42e9b4f1f89b845364bb","1271b762efa04510a724545e8422c2f8","6a979d1530b04c5aae6c543274194de1","4ac768f5b9cf4437bcd5015c863b45f1","aca93bdfeafc40389ad3afc2395462ae","42d57ffd2aec4fedbb330edbc83bda1e","6bca1ff1b6504a6c98bb3554c0911699","b955e652131b45e4b23c7118a57230bf","7c576e389f034085a3a8e0ef362cc82f","07ada7c495f9435cb58e94c787b52b03","83e2d89e12784f8da90228047f002739","0293649ab8fb4ad0b8ac980fcafc2fbf","95189155343e4f54ba44f63e25aead5f","e5d00e5ce2384efda095d37566544af7","cebc4775eb8647ebaf7af2f0af2be0fb","ee4dfd5990ef4284b3cd50cad723d37a","d004bca815604b56aba7e598bd88df77","49d075eb028541988a96445c0d8bbd2a","4c065247675041ffa87b2f0ee9c70387"],"text":"\\begin{tabular}{l}\nThe 30 day mean aortic valve pressure gradient was... \\\\\nTable 4.1-3 shows 1-year and 2-year clinical... \\\\\nAt 2 years, mortality was \\(17 \\%\\) and the disabling stroke rate was \\(3.5 \\%\\). The low paravalvular aortic regurgitation rate observed at 30 days was maintained at 2 years as most subjects ( \\(91 \\%\\) ) had none/trivial paravalvular aortic regurgitation and there was no moderate or severe paravalvular regurgitation... \\\\\nTable 4.1-3 updated to show 1-year and 2-year data for the REPRISE II main cohort \\(( N =120)\\). \\\\\nThe REPRISE II study was subsequently expanded... plus a testing margin of \\(6.2 \\%\\) ). \\%). All-cause mortality at 30 days was 4.4\\% with an upper confidence bound of 6.97\\% and the primary safety endpoint was met... \\\\\nTable 4.14 shows device performance endpoints, clinical outcomes, and echocardiographic outcomes through 30 days and 1 year for the full cohort ( \\(N =250\\). Outcomes at 30 days in the full cohort... several longitudinal registries. Through 1 year, mortality was \\(12 \\%\\) and the disabling stroke rate was \\(3.6 \\%\\). Valve endocarditis \\(( N =2)\\) and thrombosis \\(( N =3)\\) were successfully resolved with antibiotics and anticoagulant therapy, respectively, without sequelae. The low paravalvular aortic regurgitation rate observed at 30 days was maintained at 1 year as most subjects (91\\%) had none/trivial paravalvular aortic regurgitation and there was no moderate or severe paravalvular regurgitation. \\\\\nTable 4.1-4 updated to include 1-year data for the REPRISE II full cohort \\(( N =250)\\).\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nThe 30 day mean aortic valve pressure gradient was... \\\\\nTable 4.1-3 shows 1-year and 2-year clinical... \\\\\nAt 2 years, mortality was \\(17 \\%\\) and the disabling stroke rate was \\(3.5 \\%\\). The low paravalvular aortic regurgitation rate observed at 30 days was maintained at 2 years as most subjects ( \\(91 \\%\\) ) had none/trivial paravalvular aortic regurgitation and there was no moderate or severe paravalvular regurgitation... \\\\\nTable 4.1-3 updated to show 1-year and 2-year data for the REPRISE II main cohort \\(( N =120)\\). \\\\\nThe REPRISE II study was subsequently expanded... plus a testing margin of \\(6.2 \\%\\) ). \\%). All-cause mortality at 30 days was 4.4\\% with an upper confidence bound of 6.97\\% and the primary safety endpoint was met... \\\\\nTable 4.14 shows device performance endpoints, clinical outcomes, and echocardiographic outcomes through 30 days and 1 year for the full cohort ( \\(N =250\\). Outcomes at 30 days in the full cohort... several longitudinal registries. Through 1 year, mortality was \\(12 \\%\\) and the disabling stroke rate was \\(3.6 \\%\\). 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The low paravalvular aortic regurgitation rate","text_display":" without sequelae. The low paravalvular aortic regurgitation rate","confidence":1,"confidence_rate":1},{"cnt":[[1379,1469],[2163,1469],[2163,1511],[1379,1511]],"region":{"top_left_x":1378,"top_left_y":1469,"width":785,"height":42},"line":75,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"cebc4775eb8647ebaf7af2f0af2be0fb","type":"text","conversion_output":false,"parent_id":"ff96fd4bdff740a197a02a9dbe1c795a","text":"observed at 30 days was maintained at 1 year as most subjects","text_display":" observed at 30 days was maintained at 1 year as most subjects","confidence":1,"confidence_rate":1},{"cnt":[[1379,1504],[2204,1504],[2204,1545],[1379,1545]],"region":{"top_left_x":1378,"top_left_y":1504,"width":826,"height":42},"line":76,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ee4dfd5990ef4284b3cd50cad723d37a","type":"text","conversion_output":false,"parent_id":"ff96fd4bdff740a197a02a9dbe1c795a","text":"(91\\%) had none/trivial paravalvular aortic regurgitation and there","text_display":" (91\\%) had none/trivial paravalvular aortic regurgitation and there","confidence":0.9414346218109131,"confidence_rate":0.9991503558880306},{"cnt":[[1379,1543],[2061,1543],[2061,1580],[1379,1580]],"region":{"top_left_x":1378,"top_left_y":1542,"width":683,"height":38},"line":77,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d004bca815604b56aba7e598bd88df77","type":"text","conversion_output":false,"parent_id":"ff96fd4bdff740a197a02a9dbe1c795a","text":"was no moderate or severe paravalvular regurgitation.","text_display":" was no moderate or severe paravalvular 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\\multicolumn{4}{|l|}{Table 27.1-5: Table of Changes for REPRISE III Protocol Version AF (Compared to REPRISE III Protocol Version AE)} \\\\\n\\hline Section Modified & Text as Written in REPRISE III Protocol Version AE & Text as Written in REPRISE III Protocol Version AF & Justification for Modification \\\\\n\\hline 5.1 Lotus Valve System... & ... Device sizes include \\(21 mm, 23 mm, 25 mm\\), and 27 mm diameter. More detailed... & ... Device sizes used in the randomized cohort include 23 mm , 25 mm , and 27 mm diameter. Devices in the Lotus 21 mm Nested Registry cohort are 21 mm in diameter. More detailed... & Updated to include the Lotus 21 mm Nested Registry \\\\\n\\hline 5.2 CoreValve Transcatheter... & \\begin{tabular}{l}\nDevices sizes include the CoreValve \\({ }^{\\circledR}\\) Evolut \\({ }^{\\text {TM }} 23 mm\\) diameter and the CoreValve \\(26 mm . .\\). \\\\\nNote 1: Every subject must be deemed treatable...\n\\end{tabular} & \\begin{tabular}{l}\nDevices sizes include the CoreValve \\(26 mm . .\\). \\\\\nNote 1: Every subject in the randomized cohort must be deemed treatable...\n\\end{tabular} & \\multirow[t]{2}{*}{Updated for clarity; no CoreValve 23 mm device is used.} \\\\\n\\hline 5.3.2 Control Device & Information... available CoreValve \\({ }^{\\circledR}\\) and CoreValve \\({ }^{\\circledR}\\) Evolut \\({ }^{ TM }\\) 23 mm diameter or... & Information... available CoreValve \\({ }^{\\circledR}\\) or... & \\\\\n\\hline 7. Endpoints & Outcomes will be assessed... The ITT analysis population includes…first valve received. Endpoint definitions... & Outcomes will be assessed... The ITT analysis population of the randomized cohort includes ...first valve received. Among the roll-in and Lotus 21 mm Nested Registry cohorts, for ITT analyses, all subjects who sign the IRB/IEC-approved study ICF and are enrolled in the trial will be included in the analysis sample, regardless of whether the study device was implanted. For these two cohorts, the as-treated population includes all subjects implanted with the Lotus valve. Endpoint definitions... & Clarify analysis populations for rollin, randomized, and Lotus 21 mm Nested Registry cohorts. \\\\\n\\hline 8.1 Scale and Duration & The REPRISE III clinical study includes a prospective, multicenter, randomized controlled trial ... previous experience implanting the Lotus Valve. & The REPRISE III clinical study includes a prospective, multicenter, randomized controlled trial ... previous experience implanting the Lotus Valve. There will also be a single-arm, nonrandomized nested registry cohort of subjects who receive the 21 mm Lotus Valve to assess safety and effectiveness (Lotus 21 mm Nested Registry); participating centers will be centers that have enrolled subjects in REPRISE III. & \\multirow[t]{3}{*}{Clarification of overall study design.} \\\\\n\\hline 8.2 Treatment Assignment & \\begin{tabular}{l}\nEligible subjects will be randomized... \\\\\nNote: There will be... numbers.\n\\end{tabular} & \\begin{tabular}{l}\nFor the randomized cohort, eligible subjects will be randomized... \\\\\nNote: There will be... numbers. Subjects receiving the 21 mm Lotus Valve will be enrolled in a non-randomized, nested registry cohort to assess safety and effectiveness.\n\\end{tabular} & \\\\\n\\hline 8.3 Study Design Justification & There will be up to 1032 subjects in REPRISE III. In order to support... 912 subjects will be randomized and enrolled. Up to 60... & There will be up to 1052 subjects in REPRISE III. In order to support... 912 subjects will be randomized and enrolled, and up to 20 subjects will be enrolled in the Lotus 21 mm Nested Registry. Up to 60... & \\\\\n\\hline 9.2 Inclusion Criteria & IC2. Subject... and is deemed... & IC2. Subject ... and, for the randomized cohort, is deemed... & Updated for clarity \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|l|l|}\n\\hline \\multicolumn{4}{|l|}{Table 27.1-5: Table of Changes for REPRISE III Protocol Version AF (Compared to REPRISE III Protocol Version AE)} \\\\\n\\hline Section Modified & Text as Written in REPRISE III Protocol Version AE & Text as Written in REPRISE III Protocol Version AF & Justification for Modification \\\\\n\\hline 5.1 Lotus Valve System... & ... Device sizes include \\(21 mm, 23 mm, 25 mm\\), and 27 mm diameter. More detailed... & ... Device sizes used in the randomized cohort include 23 mm , 25 mm , and 27 mm diameter. 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There will also be a single-arm, nonrandomized nested registry cohort of subjects who receive the 21 mm Lotus Valve to assess safety and effectiveness (Lotus 21 mm Nested Registry); participating centers will be centers that have enrolled subjects in REPRISE III. & \\multirow[t]{3}{*}{Clarification of overall study design.} \\\\\n\\hline 8.2 Treatment Assignment & \\begin{tabular}{l}\nEligible subjects will be randomized... \\\\\nNote: There will be... numbers.\n\\end{tabular} & \\begin{tabular}{l}\nFor the randomized cohort, eligible subjects will be randomized... \\\\\nNote: There will be... numbers. Subjects receiving the 21 mm Lotus Valve will be enrolled in a non-randomized, nested registry cohort to assess safety and effectiveness.\n\\end{tabular} & \\\\\n\\hline 8.3 Study Design Justification & There will be up to 1032 subjects in REPRISE III. In order to support... 912 subjects will be randomized and enrolled. Up to 60... & There will be up to 1052 subjects in REPRISE III. 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\\multicolumn{4}{|l|}{Table 27.1-5: Table of Changes for REPRISE III Protocol Version AF (Compared to REPRISE III Protocol Version AE)} \\\\\n\\hline Section Modified & Text as Written in REPRISE III Protocol Version AE & Text as Written in REPRISE III Protocol Version AF & Justification for Modification \\\\\n\\hline 10.1.3 Lotus 21 mm Nested Registry Subjects & - & For the Lotus 21 mm Nested Registry cohort, subjects confirmed eligible for the study by the CRC (see Section 22.2) and who provided written informed consent are considered enrolled in the study as soon as an attempt is made to insert the Lotus Valve System into the subject's femoral artery. & New section added to clarify point of enrollment for the Lotus 21 mm Nested Registry cohort. \\\\\n\\hline 11.1 Data Collection & Figure 11.1-1 REPRISE III Study Design & Updated Figure 11.1-1 REPRISE III Study Design to include the 21 mm Nested Registry & Clarify that there will be up to 20 additional subjects enrolled in the study. \\\\\n\\hline 11.4 Screening Assessments & The following screening… subject eligibility. Only after CRC approval... & The following screening... subject eligibility. For the randomized cohort, only after CRC approval... & Updated for clarity \\\\\n\\hline 12.1 Endpoints & \\begin{tabular}{l}\nData from roll-in subjects (up to 120 subjects) will be summarized separately from the randomized population. Roll-in subjects will not be included in the endpoint analyses. Testing of endpoints... \\\\\n12.1.4 Baseline Comparability Baseline data will be summarized… and separately for the roll-in subjects. ... No formal statistical testing will be done for the rollin subjects. \\\\\n12.1.5 Post-procedure Measurements ... No formal statistical testing will be done for the roll-in subjects.\n\\end{tabular} & \\begin{tabular}{l}\nData will be summarized separately from subjects in the roll-in (up to 120 subjects), randomized, and Lotus 21 mm Nested Registry populations. 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\\multicolumn{4}{|l|}{Table 27.1-5: Table of Changes for REPRISE III Protocol Version AF (Compared to REPRISE III Protocol Version AE)} \\\\\n\\hline Section Modified & Text as Written in REPRISE III Protocol Version AE & Text as Written in REPRISE III Protocol Version AF & Justification for Modification \\\\\n\\hline & & \\begin{tabular}{l}\nsubjects implanted with the Lotus Valve. The As-Treated and Implanted analysis sets are the same for these two cohorts. \\\\\nFor the randomized cohort, the primary safety endpoint...\n\\end{tabular} & \\\\\n\\hline 12.2.4 Reporting Events & For all roll-in subjects, all events... For all randomized... & For all subjects in the roll-in and Lotus 21 mm Nested Registry cohorts, all events... For all randomized... & Updated for clarity \\\\\n\\hline 12.3.2 Interim Analyses & ... after these 300 patients have completed their 30-day follow-up visits. & \\begin{tabular}{l}\n... after these 300 subjects have completed their 30-day followup visits. \\\\\nAn administrative analysis of 30-day data for subjects in the Lotus 21 mm Nested Registry will be performed for regulatory agency review after these subjects have completed their 30-day follow-up visits.\n\\end{tabular} & Clarification of interim analyses \\\\\n\\hline 19. Potential Risks... & Risks… review of relevant literature, most recently… and the CoreValve High Risk Study. & Risks… review of relevant literature, most recently... the CoreValve High Risk Study \\({ }^{66}\\), and the PORTICO IDE randomized trial/RESOLVE registry/SAVORY registry. & Additional literature reference \\\\\n\\hline 21.1 Definitions and Classification & \\begin{tabular}{l}\n- If complications... protocol-specified definitions. \\\\\nAny AE experienced by the study subject beginning from the time of randomization must be recorded in the eCRF.\n\\end{tabular} & \\begin{tabular}{l}\n- If complications... protocol-specified definitions. \\\\\nFor the randomized cohort, event reporting (eCRF) is required beginning from the time of randomization. \\\\\nFor the roll-in cohort and the Lotus 21 mm Nested Registry cohort, event reporting (eCRF) is required beginning from the time an attempt is made to insert the Lotus Valve System into the subject's femoral artery.\n\\end{tabular} & Clarify timing for the different cohorts. \\\\\n\\hline 21.2 Relationship... & The Investigator must assess the relationship of the AE to the study device... & The Investigator must assess the relationship of the AE/SAE to the study device... & Updated for clarity \\\\\n\\hline 27.1.5 Protocol Version AE to Version AF & - & Table 27.1-5 lists changes between protocol versions AE and AF . New Table 27.1-5. & Provide list of changes between version AE and version AF . \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|l|l|}\n\\hline \\multicolumn{4}{|l|}{Table 27.1-5: Table of Changes for REPRISE III Protocol Version AF (Compared to REPRISE III Protocol Version AE)} \\\\\n\\hline Section Modified & Text as Written in REPRISE III Protocol Version AE & Text as Written in REPRISE III Protocol Version AF & Justification for Modification \\\\\n\\hline & & \\begin{tabular}{l}\nsubjects implanted with the Lotus Valve. The As-Treated and Implanted analysis sets are the same for these two cohorts. \\\\\nFor the randomized cohort, the primary safety endpoint...\n\\end{tabular} & \\\\\n\\hline 12.2.4 Reporting Events & For all roll-in subjects, all events... For all randomized... & For all subjects in the roll-in and Lotus 21 mm Nested Registry cohorts, all events... 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\\multicolumn{4}{|l|}{Table 27.1-6: Table of Changes for REPRISE III Protocol Version AG (Compared to REPRISE III Protocol Version AF)} \\\\\n\\hline Section Modified & Text as Written in REPRISE III Protocol Version AF & Text as Written in REPRISE III Protocol Version AG & Justification for Modification \\\\\n\\hline Page 2 & Current Version: 07-Dec-2015 & \\begin{tabular}{l}\nCurrent Version: 22-Dec-2015 \\\\\nUpdated Table of Revision History\n\\end{tabular} & Updated for clarity \\\\\n\\hline 2. Protocol Synopsis Study Design & - & - An additional cohort of subjects who will receive the Lotus Valve ( \\(23 mm, 25 mm\\), and 27 mm valve sizes) beginning after enrollment of the randomized cohort is completed (U.S. Continued Access Study cohort). This cohort will be used to further assess performance and safety. Participating centers will be United States centers that have enrolled subjects in REPRISE III. & \\multirow[t]{2}{*}{Updated to include the U.S. Continued Access study} \\\\\n\\hline 2. Protocol Synopsis Planned Subjects/... & Subjects will be enrolled at up to 60 centers in the United States, Canada, Western Europe, and Australia. There will be up to 1032 subjects in REPRISE III... Nested Registry. & Subjects will be enrolled at up to 60 centers in the United States, Canada, Western Europe, and Australia. There will be up to 2052 subjects in REPRISE III... Nested Registry. After enrollment in the randomized cohort is completed, up to 1000 subjects will be enrolled in the U.S. Continued Access Study cohort to receive the Lotus Valve ( \\(23 mm, 25 mm\\), and 27 mm valve sizes); participating centers will be United States centers that have enrolled subjects in REPRISE III. & \\\\\n\\hline 2. Protocol Synopsis Inclusion... & IC2. Subject... control device. & IC2. Subject... control device. For the U.S. Continued Access Study cohort the acceptable aortic annulus size is \\(\\geq 20 mm\\) and \\(\\leq 27 mm\\). & Updated for clarity, the U.S. Continued Access study \\\\\n\\hline 2. Protocol Synopsis Analysis Sets & Among the roll-in and the Lotus 21 mm Nested Registry cohorts, for ITT analyses... & Among the roll-in, Lotus 21 mm Nested Registry, and U.S. Continued Access Study cohorts, for ITT analyses... & \\multirow[t]{2}{*}{Updated to include the U.S. Continued Access study cohort} \\\\\n\\hline 4.0 Introduction & ...Valve (Lotus 21 mm Nested Registry). Additional... & ...Valve (Lotus 21 mm Nested Registry), or the U.S. Continued Access Study cohort. Additional... & \\\\\n\\hline 5.2 CoreValve Transcatheter... & \\begin{tabular}{l}\nDevices sizes include the CoreValve \\({ }^{\\circledR}\\) Evolut \\({ }^{\\text {TM }} 23 mm\\) diameter and the CoreValve \\(26 mm . .\\). \\\\\nNote 1: Every subject must be deemed treatable...\n\\end{tabular} & \\begin{tabular}{l}\nDevices sizes include the CoreValve \\(26 mm . .\\). \\\\\nNote 1: Every subject in the randomized cohort must be deemed treatable...\n\\end{tabular} & \\multirow[t]{2}{*}{Updated for clarity; no CoreValve 23 mm device is used.} \\\\\n\\hline 5.3.2 Control Device & Information... available CoreValve \\({ }^{\\circledR}\\) and CoreValve \\({ }^{\\circledR}\\) Evolut \\({ }^{\\text {TM }}\\) 23 mm diameter or... & Information... available CoreValve \\({ }^{\\circledR}\\) or... & \\\\\n\\hline 7. Endpoints & Outcomes will be assessed... The ITT analysis population includes…first valve received. Endpoint definitions... & Outcomes will be assessed... The ITT analysis population of the randomized cohort includes ...first valve received. Among the roll-in and Lotus 21 mm Nested Registry cohorts, for ITT analyses, all subjects who sign the IRB/IEC-approved study ICF & Clarify analysis populations for rollin, randomized, and Lotus 21 mm Nested \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|l|l|}\n\\hline \\multicolumn{4}{|l|}{Table 27.1-6: Table of Changes for REPRISE III Protocol Version AG (Compared to REPRISE III Protocol Version AF)} \\\\\n\\hline Section Modified & Text as Written in REPRISE III Protocol Version AF & Text as Written in REPRISE III Protocol Version AG & Justification for Modification \\\\\n\\hline Page 2 & Current Version: 07-Dec-2015 & \\begin{tabular}{l}\nCurrent Version: 22-Dec-2015 \\\\\nUpdated Table of Revision History\n\\end{tabular} & Updated for clarity \\\\\n\\hline 2. Protocol Synopsis Study Design & - & - An additional cohort of subjects who will receive the Lotus Valve ( \\(23 mm, 25 mm\\), and 27 mm valve sizes) beginning after enrollment of the randomized cohort is completed (U.S. Continued Access Study cohort). This cohort will be used to further assess performance and safety. Participating centers will be United States centers that have enrolled subjects in REPRISE III. & \\multirow[t]{2}{*}{Updated to include the U.S. Continued Access study} \\\\\n\\hline 2. Protocol Synopsis Planned Subjects/... & Subjects will be enrolled at up to 60 centers in the United States, Canada, Western Europe, and Australia. There will be up to 1032 subjects in REPRISE III... Nested Registry. & Subjects will be enrolled at up to 60 centers in the United States, Canada, Western Europe, and Australia. There will be up to 2052 subjects in REPRISE III... Nested Registry. After enrollment in the randomized cohort is completed, up to 1000 subjects will be enrolled in the U.S. Continued Access Study cohort to receive the Lotus Valve ( \\(23 mm, 25 mm\\), and 27 mm valve sizes); participating centers will be United States centers that have enrolled subjects in REPRISE III. & \\\\\n\\hline 2. Protocol Synopsis Inclusion... & IC2. Subject... control device. & IC2. Subject... control device. For the U.S. Continued Access Study cohort the acceptable aortic annulus size is \\(\\geq 20 mm\\) and \\(\\leq 27 mm\\). & Updated for clarity, the U.S. Continued Access study \\\\\n\\hline 2. Protocol Synopsis Analysis Sets & Among the roll-in and the Lotus 21 mm Nested Registry cohorts, for ITT analyses... & Among the roll-in, Lotus 21 mm Nested Registry, and U.S. Continued Access Study cohorts, for ITT analyses... & \\multirow[t]{2}{*}{Updated to include the U.S. Continued Access study cohort} \\\\\n\\hline 4.0 Introduction & ...Valve (Lotus 21 mm Nested Registry). Additional... & ...Valve (Lotus 21 mm Nested Registry), or the U.S. Continued Access Study cohort. Additional... & \\\\\n\\hline 5.2 CoreValve Transcatheter... & \\begin{tabular}{l}\nDevices sizes include the CoreValve \\({ }^{\\circledR}\\) Evolut \\({ }^{\\text {TM }} 23 mm\\) diameter and the CoreValve \\(26 mm . .\\). \\\\\nNote 1: Every subject must be deemed treatable...\n\\end{tabular} & \\begin{tabular}{l}\nDevices sizes include the CoreValve \\(26 mm . .\\). \\\\\nNote 1: Every subject in the randomized cohort must be deemed treatable...\n\\end{tabular} & \\multirow[t]{2}{*}{Updated for clarity; no CoreValve 23 mm device is used.} \\\\\n\\hline 5.3.2 Control Device & Information... available CoreValve \\({ }^{\\circledR}\\) and CoreValve \\({ }^{\\circledR}\\) Evolut \\({ }^{\\text {TM }}\\) 23 mm diameter or... & Information... available CoreValve \\({ }^{\\circledR}\\) or... & \\\\\n\\hline 7. Endpoints & Outcomes will be assessed... 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For these two cohorts, the as-treated population includes all subjects implanted with the Lotus valve. Endpoint definitions... & Registry cohorts. \\\\\n\\hline 8.1 Scale and Duration & ... that have enrolled subjects in REPRISE III. & ... that have enrolled subjects in REPRISE III. After enrollment of the randomized cohort is completed, an additional cohort of subjects will be enrolled in a U.S. Continued Access Study cohort with the Lotus Valve ( 23 mm , 25 mm , and 27 mm valve sizes) to further assess performance and safety. & \\multirow[t]{3}{*}{Updated to include the U.S. Continued Access study cohort} \\\\\n\\hline 8.2 Treatment Assignment & Note: There will be… to assess safety and effectiveness. & Note: There will be... to assess safety and effectiveness. After enrollment of the randomized cohort is completed, subjects will be enrolled in a U.S. Continued Access Study cohort with the Lotus Valve ( \\(23 mm, 25 mm\\), and 27 mm valve sizes) to further assess performance and safety. & \\\\\n\\hline 8.3 Study Design Justification & There will be up to 1052 subjects in REPRISE III... Nested Registry. Up to 60... in the study. Safety... & There will be up to 2052 subjects in REPRISE III... Nested Registry, and up to 1000 subjects will be enrolled in the U.S. Continued Access Study cohort. Up to \\(60 \\ldots\\) in the study. Centers in the United States that enrolled subjects in the randomized cohort will be eligible to enroll subjects in the U.S. Continued Access Study cohort. Safety... & \\\\\n\\hline 9.2 Inclusion Criteria & IC2. Subject... control device. & IC2. Subject ... control device. For the U.S. Continued Access Study cohort the acceptable aortic annulus size is \\(\\geq 20 mm\\) and \\(\\leq 27 mm\\). & U.S. Continued Access Study includes only 23 mm , 25 mm , and 27 mm Lotus Valve sizes. \\\\\n\\hline 10.1.4 U.S. Continued Access Subjects & - & For the U.S. Continued Access Study cohort, subjects confirmed eligible for the study by the CRC (see Section 22.2) and who provided written informed consent are considered enrolled in the study as soon as an attempt is made to insert the Lotus Valve System into the subject's femoral artery. & New section added to clarify point of enrollment for the U.S. Continued Access Study cohort. \\\\\n\\hline 11.1 Data Collection & Figure 11.1-1 REPRISE III Study Design & Updated Figure 11.1-1 REPRISE III Study Design to include the U.S. Continued Access Study. & Clarify that there will be up to 1000 additional subjects \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Table 27.1-6: Table of Changes for REPRISE III Protocol Version AG (Compared to REPRISE III Protocol Version AF)}\n\\begin{tabular}{|l|l|l|l|}\n\\hline Section Modified & Text as Written in REPRISE III Protocol Version AF & Text as Written in REPRISE III Protocol Version AG & Justification for Modification \\\\\n\\hline & & and are enrolled in the trial will be included in the analysis sample, regardless of whether the study device was implanted. For these two cohorts, the as-treated population includes all subjects implanted with the Lotus valve. Endpoint definitions... & Registry cohorts. \\\\\n\\hline 8.1 Scale and Duration & ... that have enrolled subjects in REPRISE III. & ... that have enrolled subjects in REPRISE III. After enrollment of the randomized cohort is completed, an additional cohort of subjects will be enrolled in a U.S. Continued Access Study cohort with the Lotus Valve ( 23 mm , 25 mm , and 27 mm valve sizes) to further assess performance and safety. & \\multirow[t]{3}{*}{Updated to include the U.S. Continued Access study cohort} \\\\\n\\hline 8.2 Treatment Assignment & Note: There will be… to assess safety and effectiveness. & Note: There will be... to assess safety and effectiveness. 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perform a separate CT scan if clinically indicated.","text_display":" instead should perform a separate CT scan if clinically indicated.","confidence":1,"confidence_rate":1},{"cnt":[[1379,1062],[2178,1062],[2178,1099],[1379,1099]],"region":{"top_left_x":1378,"top_left_y":1062,"width":800,"height":38},"line":47,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4eb13834d1b9436c98972145c833e8a0","type":"text","conversion_output":false,"parent_id":"2182a06137214170993631599aa0e88b","text":"If an additional CT scan is performed for clinical indications, it","text_display":" If an additional CT scan is performed for clinical indications, 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Section Modified & Text as Written in REPRISE III Protocol Version AH & Text as Written in REPRISE III Protocol Version AI & Justification for Modification \\\\\n\\hline Page 2 & Current Version: 05-May-2016 & \\begin{tabular}{l}\nCurrent Version: 19-Jan-2017 \\\\\nUpdated Table of Revision History\n\\end{tabular} & \\multirow[t]{4}{*}{\\begin{tabular}{l}\nUpdated to include the 29 mm LOTUS \\\\\nEdge Nested Registry\n\\end{tabular}} \\\\\n\\hline 2. Protocol Synopsis, Objective & To evaluate the safety and effectiveness of the Lotus \\({ }^{\\text {TM }}\\) Valve System for transcatheter... & To evaluate the safety and effectiveness of the Lotus \\({ }^{\\text {TM }}\\) Valve System and LOTUS Edge \\({ }^{\\text {TM }}\\) Valve System for transcatheter... & \\\\\n\\hline 2. Protocol Synopsis, Intended Use & The Lotus Valve System is intended... & The Lotus Valve System and LOTUS Edge Valve System are intended... & \\\\\n\\hline 2. Protocol Synopsis, Test Devices and... & \\begin{tabular}{l}\nThe Lotus Valve System consisting of two main components: \\\\\n- a bioprosthetic bovine pericardial aortic valve, and \\\\\n- a delivery system. \\\\\nDevices sizes include \\(21 mm, 23 mm, 25 mm\\), and 27 mm diameter.\n\\end{tabular} & \\begin{tabular}{l}\nThe Lotus Valve System and LOTUS Edge Valve System consisting of two main components: \\\\\n- a bioprosthetic bovine pericardial aortic valve, and \\\\\n- a delivery system. \\\\\nDevices sizes for the Lotus Valve System include 21 mm , \\(23 mm, 25 mm\\), and 27 mm diameter. \\\\\nDevice size for the LOTUS Edge Valve System is 29 mm diameter. \\\\\nNote: LOTUS Edge is a design iteration of the Lotus Valve System. 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Protocol Synopsis, Objective & To evaluate the safety and effectiveness of the Lotus \\({ }^{\\text {TM }}\\) Valve System for transcatheter... & To evaluate the safety and effectiveness of the Lotus \\({ }^{\\text {TM }}\\) Valve System and LOTUS Edge \\({ }^{\\text {TM }}\\) Valve System for transcatheter... & \\\\\n\\hline 2. Protocol Synopsis, Intended Use & The Lotus Valve System is intended... & The Lotus Valve System and LOTUS Edge Valve System are intended... & \\\\\n\\hline 2. 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Protocol Synopsis, Analysis Sets... & Among the roll-in, Lotus 21 mm Nested Registry, and… & Among the roll-in (initial cohort with the \\(23 mm, 25 mm\\), and 27 mm Lotus), Lotus 21 mm Nested Registry, roll-in with the 29 mm LOTUS Edge, LOTUS Edge 29 mm Nested Registry, and... & \\multirow{3}{*}{} \\\\\n\\hline 4. Introduction & ...evaluation of the Lotus \\({ }^{\\text {TM }}\\) Valve System, a transfemoral aortic valve replacement device designed and manufactured by Boston Scientific Structural Heart a Division of Boston Scientific Corporation (BSC). The Lotus Valve System consists of a preloaded... paravalvular leakage. ... study subjects... cohort). Additional... & ...evaluation of the Lotus \\({ }^{\\text {TM }}\\) Valve System and LOTUS Edge \\({ }^{\\text {TM }}\\) Valve System, transfemoral aortic valve replacement devices designed and manufactured by Boston Scientific Structural Heart a Division of Boston Scientific Corporation (BSC). 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Controlled mechanical expansion and early leaflet functioning allow for precise positioning. If needed, minor repositioning is accomplished through partial valve recapture; full recapture facilitates removal of the valve if a different size or valve is required. 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The Lotus Valve System is under study in the ongoing REPRISE I (ClinicalTrials.gov Identifier NCT01383720), REPRISE II (NCT01627691), and REPRISE Japan (NCT02491255) singlearm trials; the REPRISE III (NCT02202434) randomized controlled trial; and the RESPOND (NCT02031302) postmarket safety surveillance study. The LOTUS Edge Valve System (23 \\(mm , 25 mm\\) and 27 mm valve sizes) is currently under study in the REPRISE NG DS (NCT02329496) and the REPRISE EDGE (NCT02854319) single-arm trials. The REPRISE NG DS study recently completed enrollment in Australia, while the REPRISE Edge study is currently enrolling in Europe. The REPRISE EDGE 29 mm EU study is intended to evaluate performance and safety of the 29 mm LOTUS Edge Valve System among centers in Europe. & \\\\\n\\hline 4.1.3 REPRISE II & \\begin{tabular}{l}\nThe low paravalvular aortic regurgitation rate observed at 30 days was maintained at 1 year as most subjects ( \\(91 \\%\\) ) had none/trivial... \\\\\nTable 4.1-4\n\\begin{tabular}{|l|c|c|}\n\\hline Outcomes & \\begin{tabular}{l} \nREPRISE II \\\\\n\\(( 3 0 ~ D a y s )\\)\n\\end{tabular} & \\begin{tabular}{l} \nREPRISE II \\\\\n\\(( 1 ~ Y e a r )\\)\n\\end{tabular} \\\\\n\\hline None & \\(80.2 \\%(142 / 177)\\) & \\(83.4 \\%(136 / 163)\\) \\\\\n\\hline Trace/Trivial & \\(5.6 \\%(10 / 177)\\) & \\(8.0 \\%(13 / 163)\\) \\\\\n\\hline Mild & \\(13.6 \\%(24 / 177)\\) & \\(8.6 \\%(14 / 163)\\) \\\\\n\\hline\n\\end{tabular}\n\\end{tabular} & \\begin{tabular}{l}\nThe low paravalvular aortic regurgitation rate observed at 30 days was maintained at 1 year as most subjects ( \\(85 \\%\\) ) had none/trivial... \\\\\nTable 4.1-4\n\\begin{tabular}{|l|c|c|}\n\\hline Outcomes & \\begin{tabular}{l} \nREPRISE II \\\\\n\\(( 3 0 ~ D a y s )\\)\n\\end{tabular} & \\begin{tabular}{l} \nREPRISE II \\\\\n\\(( 1\\) Year)\n\\end{tabular} \\\\\n\\hline None & \\(80.2 \\%(142 / 177)\\) & \\(82.2 \\%(134 / 163)\\) \\\\\n\\hline Trace/Trivial & \\(5.6 \\%(10 / 177)\\) & \\(3.1 \\%(5 / 163)\\) \\\\\n\\hline Mild & \\(13.6 \\%(24 / 177)\\) & \\(14.7 \\%(24 / 163)\\) \\\\\n\\hline\n\\end{tabular}\n\\end{tabular} & Updated data \\\\\n\\hline 4.1.4 REPRISE NG DS Study & - & \\begin{tabular}{l}\n4.1.4 REPRISE NG DS Study \\\\\nThe LOTUS Edge Valve System with a modified iteration of the delivery system studied in REPRISE I and REPRISE II was evaluated in the REpositionable Percutaneous Replacement of Stenotic Aortic Valve through Implantation of LotuS ValvE with the Next Generation Delivery System (REPRISE NG DS) first-human-use trial. In Cohort A of this prospective single-arm study, 10 subjects were enrolled at 2 investigative centers in Australia; the device was introduced into the body using the Lotus Introducer Set. In Cohort B, an additional 7 subjects were\n\\end{tabular} & New data to support inclusion of the 29 mm LOTUS Edge Nested Registry. \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Table 27.1-8: Table of Changes for REPRISE III Protocol Version AI (Compared to REPRISE III Protocol Version AH)}\n\\begin{tabular}{|l|l|l|l|}\n\\hline Section Modified & Text as Written in REPRISE III Protocol Version AH & Text as Written in REPRISE III Protocol Version AI & Justification for Modification \\\\\n\\hline & & program (see Section 4.1.2 through Section 4.1.4). The Lotus Valve System is under study in the ongoing REPRISE I (ClinicalTrials.gov Identifier NCT01383720), REPRISE II (NCT01627691), and REPRISE Japan (NCT02491255) singlearm trials; the REPRISE III (NCT02202434) randomized controlled trial; and the RESPOND (NCT02031302) postmarket safety surveillance study. The LOTUS Edge Valve System (23 \\(mm , 25 mm\\) and 27 mm valve sizes) is currently under study in the REPRISE NG DS (NCT02329496) and the REPRISE EDGE (NCT02854319) single-arm trials. The REPRISE NG DS study recently completed enrollment in Australia, while the REPRISE Edge study is currently enrolling in Europe. 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In Cohort A of this prospective single-arm study, 10 subjects were enrolled at 2 investigative centers in Australia; the device was introduced into the body using the Lotus Introducer Set. In Cohort B, an additional 7 subjects were\n\\end{tabular} & New data to support inclusion of the 29 mm LOTUS Edge Nested Registry. 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The Lotus Valve System is under study in the ongoing REPRISE I (ClinicalTrials.gov Identifier NCT01383720), REPRISE II (NCT01627691), and REPRISE Japan (NCT02491255) singlearm trials; the REPRISE III (NCT02202434) randomized controlled trial; and the RESPOND (NCT02031302) postmarket safety surveillance study. The LOTUS Edge Valve System (23 \\(mm , 25 mm\\) and 27 mm valve sizes) is currently under study in the REPRISE NG DS (NCT02329496) and the REPRISE EDGE (NCT02854319) single-arm trials. The REPRISE NG DS study recently completed enrollment in Australia, while the REPRISE Edge study is currently enrolling in Europe. The REPRISE EDGE 29 mm EU study is intended to evaluate performance and safety of the 29 mm LOTUS Edge Valve System among centers in Europe.","text_display":"program (see Section 4.1.2 through Section 4.1.4). The Lotus Valve System is under study in the ongoing REPRISE I (ClinicalTrials.gov Identifier NCT01383720), REPRISE II (NCT01627691), and REPRISE Japan (NCT02491255) singlearm trials; the REPRISE III (NCT02202434) randomized controlled trial; and the RESPOND (NCT02031302) postmarket safety surveillance study. The LOTUS Edge Valve System (23 \\(mm , 25 mm\\) and 27 mm valve sizes) is currently under study in the REPRISE NG DS (NCT02329496) and the REPRISE EDGE (NCT02854319) single-arm trials. The REPRISE NG DS study recently completed enrollment in Australia, while the REPRISE Edge study is currently enrolling in Europe. The REPRISE EDGE 29 mm EU study is intended to evaluate performance and safety of the 29 mm LOTUS Edge Valve System among centers in Europe.","cell_row":1,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":0.71875,"confidence_rate":0.9994518681790936},{"cnt":[[1379,503],[2152,503],[2152,540],[1379,540]],"region":{"top_left_x":1378,"top_left_y":502,"width":774,"height":38},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"630b1d69da884fac88c09b6033c4927b","type":"text","conversion_output":false,"parent_id":"38290f1f3dc64b3587329984568783d1","text":"program (see Section 4.1.2 through Section 4.1.4). The Lotus","text_display":"program (see Section 4.1.2 through Section 4.1.4). The Lotus","confidence":1,"confidence_rate":1},{"cnt":[[1379,538],[2083,538],[2083,574],[1379,574]],"region":{"top_left_x":1378,"top_left_y":537,"width":705,"height":38},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4102dde1ceed405dab537d319e78814a","type":"text","conversion_output":false,"parent_id":"38290f1f3dc64b3587329984568783d1","text":"Valve System is under study in the ongoing REPRISE I","text_display":" Valve System is under study in the ongoing REPRISE I","confidence":1,"confidence_rate":1},{"cnt":[[1379,572],[2121,572],[2121,611],[1379,611]],"region":{"top_left_x":1378,"top_left_y":572,"width":744,"height":40},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b56eaff077f246d3868ee4fee0a8f1ff","type":"text","conversion_output":false,"parent_id":"38290f1f3dc64b3587329984568783d1","text":"(ClinicalTrials.gov Identifier NCT01383720), REPRISE II","text_display":" (ClinicalTrials.gov Identifier NCT01383720), REPRISE II","confidence":1,"confidence_rate":1},{"cnt":[[1379,609],[2178,609],[2178,648],[1379,648]],"region":{"top_left_x":1378,"top_left_y":609,"width":800,"height":40},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"10ad1d38691e4105893a972f8a6e910d","type":"text","conversion_output":false,"parent_id":"38290f1f3dc64b3587329984568783d1","text":"(NCT01627691), and REPRISE Japan (NCT02491255) single-","text_display":" (NCT01627691), and REPRISE Japan (NCT02491255) single","confidence":1,"confidence_rate":1},{"cnt":[[1379,646],[2104,646],[2104,683],[1379,683]],"region":{"top_left_x":1378,"top_left_y":645,"width":727,"height":38},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d0fdcabe7c4c4152bc1e0d2733383883","type":"text","conversion_output":false,"parent_id":"38290f1f3dc64b3587329984568783d1","text":"arm trials; the REPRISE III (NCT02202434) randomized","text_display":"arm trials; the REPRISE III (NCT02202434) randomized","confidence":1,"confidence_rate":1},{"cnt":[[1379,681],[2191,681],[2191,717],[1379,717]],"region":{"top_left_x":1378,"top_left_y":680,"width":813,"height":38},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"178a071ce8ff463dafc1c835b34bf043","type":"text","conversion_output":false,"parent_id":"38290f1f3dc64b3587329984568783d1","text":"controlled trial; and the RESPOND (NCT02031302) postmarket","text_display":" controlled trial; and the RESPOND (NCT02031302) postmarket","confidence":1,"confidence_rate":1},{"cnt":[[1379,717],[2169,717],[2169,756],[1379,756]],"region":{"top_left_x":1378,"top_left_y":717,"width":792,"height":40},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"751091361e794ea39494d7faa7420d64","type":"text","conversion_output":false,"parent_id":"38290f1f3dc64b3587329984568783d1","text":"safety surveillance study. The LOTUS Edge Valve System (23","text_display":" safety surveillance study. The LOTUS Edge Valve System (23","confidence":0.81982421875,"confidence_rate":0.9968515488781904},{"cnt":[[1379,754],[2176,754],[2176,791],[1379,791]],"region":{"top_left_x":1378,"top_left_y":754,"width":798,"height":37},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"014fa69115bd4e0b91c1d317cc63d678","type":"text","conversion_output":false,"parent_id":"38290f1f3dc64b3587329984568783d1","text":"\\(mm , 25 mm\\) and 27 mm valve sizes) is currently under study in","text_display":" \\(mm , 25 mm\\) and 27 mm valve sizes) is currently under study in","confidence":0.990234375,"confidence_rate":0.9998655758652087},{"cnt":[[1379,789],[2195,789],[2195,826],[1379,826]],"region":{"top_left_x":1378,"top_left_y":788,"width":818,"height":38},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6dc171c46ec343348acac8e8e256dcb6","type":"text","conversion_output":false,"parent_id":"38290f1f3dc64b3587329984568783d1","text":"the REPRISE NG DS (NCT02329496) and the REPRISE EDGE","text_display":" the REPRISE NG DS (NCT02329496) and the REPRISE EDGE","confidence":1,"confidence_rate":1},{"cnt":[[1379,823],[2178,823],[2178,862],[1379,862]],"region":{"top_left_x":1378,"top_left_y":823,"width":800,"height":40},"line":39,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"be16121cda3c4250a5ab1377a54deccb","type":"text","conversion_output":false,"parent_id":"38290f1f3dc64b3587329984568783d1","text":"(NCT02854319) single-arm trials. The REPRISE NG DS study","text_display":" (NCT02854319) single-arm trials. The REPRISE NG DS study","confidence":1,"confidence_rate":1},{"cnt":[[1379,862],[2186,862],[2186,899],[1379,899]],"region":{"top_left_x":1378,"top_left_y":862,"width":809,"height":38},"line":40,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"071c2b7929db41e0b942627c8aa35ae7","type":"text","conversion_output":false,"parent_id":"38290f1f3dc64b3587329984568783d1","text":"recently completed enrollment in Australia, while the REPRISE","text_display":" recently completed enrollment in Australia, while the REPRISE","confidence":0.99951171875,"confidence_rate":0.9999926000198329},{"cnt":[[1379,897],[2121,897],[2121,934],[1379,934]],"region":{"top_left_x":1378,"top_left_y":897,"width":744,"height":37},"line":41,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"23faa1f52d794be9a2047aad0931a7ca","type":"text","conversion_output":false,"parent_id":"38290f1f3dc64b3587329984568783d1","text":"Edge study is currently enrolling in Europe. The REPRISE","text_display":" Edge study is currently enrolling in Europe. The REPRISE","confidence":1,"confidence_rate":1},{"cnt":[[1379,932],[2195,932],[2195,969],[1379,969]],"region":{"top_left_x":1378,"top_left_y":931,"width":818,"height":38},"line":42,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"98d98fd431744b90ac76b292f356fc4b","type":"text","conversion_output":false,"parent_id":"38290f1f3dc64b3587329984568783d1","text":"EDGE 29 mm EU study is intended to evaluate performance and","text_display":" EDGE 29 mm EU study is intended to evaluate performance and","confidence":1,"confidence_rate":1},{"cnt":[[1379,966],[2186,966],[2186,1008],[1379,1008]],"region":{"top_left_x":1378,"top_left_y":966,"width":809,"height":42},"line":43,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e0cccf5bbbb1429eaf4a946e4f0cf561","type":"text","conversion_output":false,"parent_id":"38290f1f3dc64b3587329984568783d1","text":"safety of the 29 mm LOTUS Edge Valve System among centers","text_display":" safety of the 29 mm LOTUS Edge Valve System among centers","confidence":0.71875,"confidence_rate":0.9950831470892746},{"cnt":[[1379,1005],[1515,1005],[1515,1042],[1379,1042]],"region":{"top_left_x":1378,"top_left_y":1005,"width":138,"height":38},"line":44,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5a9517544176428cb67ced80e0eef97e","type":"text","conversion_output":false,"parent_id":"38290f1f3dc64b3587329984568783d1","text":"in Europe.","text_display":" in Europe.","confidence":1,"confidence_rate":1},{"cnt":[[257,1044],[432,1044],[432,1120],[257,1120]],"region":{"top_left_x":256,"top_left_y":1044,"width":177,"height":77},"line":45,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bb9547fabe404bfb93874e564bb73cf6","type":"complex_cell","conversion_output":false,"parent_id":"55977ee34f4d40c69e52bd29105db143","children_ids":["74a6ea0db91f49839b2157c56ca9dd4b","b51ceb47ca96427bafb400f4afb53615"],"text":"4.1.3 REPRISE II","text_display":"4.1.3 REPRISE II","cell_row":2,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[266,1049],[335,1049],[335,1083],[266,1083]],"region":{"top_left_x":265,"top_left_y":1048,"width":70,"height":36},"line":46,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"74a6ea0db91f49839b2157c56ca9dd4b","type":"text","conversion_output":false,"parent_id":"bb9547fabe404bfb93874e564bb73cf6","text":"4.1.3","text_display":"4.1.3","confidence":1,"confidence_rate":1},{"cnt":[[266,1085],[428,1085],[428,1116],[266,1116]],"region":{"top_left_x":265,"top_left_y":1085,"width":164,"height":31},"line":47,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b51ceb47ca96427bafb400f4afb53615","type":"text","conversion_output":false,"parent_id":"bb9547fabe404bfb93874e564bb73cf6","text":"REPRISE II","text_display":" REPRISE II","confidence":1,"confidence_rate":1},{"cnt":[[510,1044],[1348,1044],[1348,1417],[510,1417]],"region":{"top_left_x":510,"top_left_y":1044,"width":839,"height":373},"line":48,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"93ca43173d2848c8a46e8f7ebe0bb898","type":"complex_cell","conversion_output":false,"parent_id":"55977ee34f4d40c69e52bd29105db143","children_ids":["9e89e85f1543402eb18a396f2b6dbf1a","12ac37b13efe41f2889ca4a3659e4b28","e57b92e9f82f47de8cc2ba280a524aeb","6ba06b6cc6a246e2b4c7d153a5e3aa39","0d973518a1ad45adbc0ca03dd750e5a4"],"text":"\\begin{tabular}{l}\nThe low paravalvular aortic regurgitation rate observed at 30 days was maintained at 1 year as most subjects ( \\(91 \\%\\) ) had none/trivial... \\\\\nTable 4.1-4\n\\begin{tabular}{|l|c|c|}\n\\hline Outcomes & \\begin{tabular}{l} \nREPRISE II \\\\\n\\(( 3 0 ~ D a y s )\\)\n\\end{tabular} & \\begin{tabular}{l} \nREPRISE II \\\\\n\\(( 1 ~ Y e a r )\\)\n\\end{tabular} \\\\\n\\hline None & \\(80.2 \\%(142 / 177)\\) & \\(83.4 \\%(136 / 163)\\) \\\\\n\\hline Trace/Trivial & \\(5.6 \\%(10 / 177)\\) & \\(8.0 \\%(13 / 163)\\) \\\\\n\\hline Mild & \\(13.6 \\%(24 / 177)\\) & \\(8.6 \\%(14 / 163)\\) \\\\\n\\hline\n\\end{tabular}\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nThe low paravalvular aortic regurgitation rate observed at 30 days was maintained at 1 year as most subjects ( \\(91 \\%\\) ) had none/trivial... \\\\\nTable 4.1-4\n\\begin{tabular}{|l|c|c|}\n\\hline Outcomes & \\begin{tabular}{l} \nREPRISE II \\\\\n\\(( 3 0 ~ D a y s )\\)\n\\end{tabular} & \\begin{tabular}{l} \nREPRISE II \\\\\n\\(( 1 ~ Y e a r )\\)\n\\end{tabular} \\\\\n\\hline None & \\(80.2 \\%(142 / 177)\\) & \\(83.4 \\%(136 / 163)\\) \\\\\n\\hline Trace/Trivial & \\(5.6 \\%(10 / 177)\\) & \\(8.0 \\%(13 / 163)\\) \\\\\n\\hline Mild & \\(13.6 \\%(24 / 177)\\) & \\(8.6 \\%(14 / 163)\\) \\\\\n\\hline\n\\end{tabular}\n\\end{tabular}","cell_row":2,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.19667505694911774,"confidence_rate":0.9987053888430247},{"cnt":[[517,1049],[1286,1049],[1286,1085],[517,1085]],"region":{"top_left_x":516,"top_left_y":1048,"width":770,"height":38},"line":49,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9e89e85f1543402eb18a396f2b6dbf1a","type":"text","conversion_output":false,"parent_id":"93ca43173d2848c8a46e8f7ebe0bb898","text":"The low paravalvular aortic regurgitation rate observed at 30","text_display":"The low paravalvular aortic regurgitation rate observed at 30","confidence":1,"confidence_rate":1},{"cnt":[[517,1085],[1251,1085],[1251,1122],[517,1122]],"region":{"top_left_x":516,"top_left_y":1085,"width":735,"height":38},"line":50,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"12ac37b13efe41f2889ca4a3659e4b28","type":"text","conversion_output":false,"parent_id":"93ca43173d2848c8a46e8f7ebe0bb898","text":"days was maintained at 1 year as most subjects ( \\(91 \\%\\) ) had","text_display":" days was maintained at 1 year as most subjects ( \\(91 \\%\\) ) had","confidence":0.9965853681787848,"confidence_rate":0.9999504291274917},{"cnt":[[517,1122],[697,1122],[697,1155],[517,1155]],"region":{"top_left_x":516,"top_left_y":1122,"width":181,"height":33},"line":51,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e57b92e9f82f47de8cc2ba280a524aeb","type":"text","conversion_output":false,"parent_id":"93ca43173d2848c8a46e8f7ebe0bb898","text":"none/trivial...","text_display":" none/trivial...","confidence":1,"confidence_rate":1},{"cnt":[[517,1161],[673,1161],[673,1194],[517,1194]],"region":{"top_left_x":516,"top_left_y":1161,"width":157,"height":33},"line":52,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6ba06b6cc6a246e2b4c7d153a5e3aa39","type":"text","conversion_output":false,"parent_id":"93ca43173d2848c8a46e8f7ebe0bb898","text":"Table 4.1-4","text_display":"\nTable 4.1-4","confidence":1,"confidence_rate":1},{"cnt":[[513,1192],[1346,1192],[1346,1417],[513,1417]],"region":{"top_left_x":512,"top_left_y":1191,"width":835,"height":226},"line":53,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0d973518a1ad45adbc0ca03dd750e5a4","type":"table","conversion_output":false,"parent_id":"93ca43173d2848c8a46e8f7ebe0bb898","text":"\\begin{tabular}{|l|c|c|}\n\\hline Outcomes & \\begin{tabular}{l} \nREPRISE II \\\\\n\\(( 3 0 ~ D a y s )\\)\n\\end{tabular} & \\begin{tabular}{l} \nREPRISE II \\\\\n\\(( 1 ~ Y e a r )\\)\n\\end{tabular} \\\\\n\\hline None & \\(80.2 \\%(142 / 177)\\) & \\(83.4 \\%(136 / 163)\\) \\\\\n\\hline Trace/Trivial & \\(5.6 \\%(10 / 177)\\) & \\(8.0 \\%(13 / 163)\\) \\\\\n\\hline Mild & \\(13.6 \\%(24 / 177)\\) & \\(8.6 \\%(14 / 163)\\) \\\\\n\\hline\n\\end{tabular}","text_display":"\n\\begin{tabular}{|l|c|c|}\n\\hline Outcomes & \\begin{tabular}{l} \nREPRISE II \\\\\n\\(( 3 0 ~ D a y s )\\)\n\\end{tabular} & \\begin{tabular}{l} \nREPRISE II \\\\\n\\(( 1 ~ Y e a r )\\)\n\\end{tabular} \\\\\n\\hline None & \\(80.2 \\%(142 / 177)\\) & \\(83.4 \\%(136 / 163)\\) \\\\\n\\hline Trace/Trivial & \\(5.6 \\%(10 / 177)\\) & \\(8.0 \\%(13 / 163)\\) \\\\\n\\hline Mild & \\(13.6 \\%(24 / 177)\\) & \\(8.6 \\%(14 / 163)\\) \\\\\n\\hline\n\\end{tabular}","confidence":0.19667505694911774,"confidence_rate":0.9935929359804807},{"cnt":[[1374,1044],[2212,1044],[2212,1415],[1374,1415]],"region":{"top_left_x":1374,"top_left_y":1044,"width":839,"height":371},"line":54,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5f5ddf26272a433598ad0fed4138c7bc","type":"complex_cell","conversion_output":false,"parent_id":"55977ee34f4d40c69e52bd29105db143","children_ids":["21197deb14684d10b5480dad7bb0009c","ac9219cd636346969cb2b1670e3d87e5","68a497d5dba140ddbca964b30eff81a6","30e6255db6af4424a3807ced6a93c751","92a9c1e9fd06420b8136dbbbc47f79e4"],"text":"\\begin{tabular}{l}\nThe low paravalvular aortic regurgitation rate observed at 30 days was maintained at 1 year as most subjects ( \\(85 \\%\\) ) had none/trivial... \\\\\nTable 4.1-4\n\\begin{tabular}{|l|c|c|}\n\\hline Outcomes & \\begin{tabular}{l} \nREPRISE II \\\\\n\\(( 3 0 ~ D a y s )\\)\n\\end{tabular} & \\begin{tabular}{l} \nREPRISE II \\\\\n\\(( 1\\) Year)\n\\end{tabular} \\\\\n\\hline None & \\(80.2 \\%(142 / 177)\\) & \\(82.2 \\%(134 / 163)\\) \\\\\n\\hline Trace/Trivial & \\(5.6 \\%(10 / 177)\\) & \\(3.1 \\%(5 / 163)\\) \\\\\n\\hline Mild & \\(13.6 \\%(24 / 177)\\) & \\(14.7 \\%(24 / 163)\\) \\\\\n\\hline\n\\end{tabular}\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nThe low paravalvular aortic regurgitation rate observed at 30 days was maintained at 1 year as most subjects ( \\(85 \\%\\) ) had none/trivial... \\\\\nTable 4.1-4\n\\begin{tabular}{|l|c|c|}\n\\hline Outcomes & \\begin{tabular}{l} \nREPRISE II \\\\\n\\(( 3 0 ~ D a y s )\\)\n\\end{tabular} & \\begin{tabular}{l} \nREPRISE II \\\\\n\\(( 1\\) Year)\n\\end{tabular} \\\\\n\\hline None & \\(80.2 \\%(142 / 177)\\) & \\(82.2 \\%(134 / 163)\\) \\\\\n\\hline Trace/Trivial & \\(5.6 \\%(10 / 177)\\) & \\(3.1 \\%(5 / 163)\\) \\\\\n\\hline Mild & \\(13.6 \\%(24 / 177)\\) & \\(14.7 \\%(24 / 163)\\) \\\\\n\\hline\n\\end{tabular}\n\\end{tabular}","cell_row":2,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":0.28177799187720176,"confidence_rate":0.9985282006062267},{"cnt":[[1379,1049],[2145,1049],[2145,1085],[1379,1085]],"region":{"top_left_x":1378,"top_left_y":1048,"width":768,"height":38},"line":55,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"21197deb14684d10b5480dad7bb0009c","type":"text","conversion_output":false,"parent_id":"5f5ddf26272a433598ad0fed4138c7bc","text":"The low paravalvular aortic regurgitation rate observed at 30","text_display":"The low paravalvular aortic regurgitation rate observed at 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Cohort B also assessed the acute performance and safety of an early iteration of the iSleeve Introducer Set and its compatibility with the LOTUS Edge device. Device sizes evaluated included the \\(23 mm, 25 mm\\) and 27 mm . The primary endpoint of the study was technical success, defined as follows: successful vascular access, delivery and deployment of the Lotus valve and successful retrieval with the LOTUS Edge delivery system; correct positioning of the Lotus valve in the proper anatomical location; and only one Lotus valve implanted in the proper anatomical location. Other measurements incorporated data collection and endpoints recommended and defined by the VARC 172 and VARC 273 guidelines. Clinical follow-up will extend through 1 year. \\\\\nThe primary endpoint was achieved in 10/10 subjects in Cohort A108 and 5/7 in Cohort B (in 1 subject a valve was not implanted and in 1 subject a valve was implanted using the current Lotus Valve System). Table 4.15 shows core lab analyses of prosthetic valve performance as assessed by TTE for the 2 cohorts. In both cohorts, mean aortic valve area and mean gradient improved at discharge and remained improved at 30 days. There were no cases of moderate or severe PVR at discharge or 30 days in either cohort. Table 4.16 shows rates of CEC-adjudicated VARCdefined events during the index procedure, through discharge/7 days, and to 30 days. In Cohort A, one subject experienced the majority of events and subsequently died on day 13 post implant. In Cohort B, events were minimal. In summary, acute and 30-day outcomes in the REPRISE NG DS study demonstrate acceptable performance and safety of the LOTUS Edge System. \\\\\nAdded new Table 4.1-5 and new Table 4.1-6.\n\\end{tabular} & \\\\\n\\hline 4.2 Justification for the Study & As noted above, the Lotus Valve System potentially provides a number... The anticipated risks and benefits associated both with the Lotus Valve System and with participation... The conclusion of this risk-benefit analysis demonstrates that the known risks & As noted above, the Lotus Valve System and LOTUS Edge Valve System potentially provide a number... The anticipated risks and benefits associated both with the Lotus Valve System/LOTUS Edge Valve System and with participation... & Updated to include the 29 mm LOTUS Edge Nested Registry \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Table 27.1-8: Table of Changes for REPRISE III Protocol Version AI (Compared to REPRISE III Protocol Version AH)}\n\\begin{tabular}{|l|l|l|l|}\n\\hline Section Modified & Text as Written in REPRISE III Protocol Version AH & Text as Written in REPRISE III Protocol Version AI & Justification for Modification \\\\\n\\hline & & \\begin{tabular}{l}\nenrolled at the same centers to evaluate acute performance and safety of a further optimized version of the LOTUS Edge device (including radiopaque markers on the valve locking assembly). Cohort B also assessed the acute performance and safety of an early iteration of the iSleeve Introducer Set and its compatibility with the LOTUS Edge device. Device sizes evaluated included the \\(23 mm, 25 mm\\) and 27 mm . The primary endpoint of the study was technical success, defined as follows: successful vascular access, delivery and deployment of the Lotus valve and successful retrieval with the LOTUS Edge delivery system; correct positioning of the Lotus valve in the proper anatomical location; and only one Lotus valve implanted in the proper anatomical location. Other measurements incorporated data collection and endpoints recommended and defined by the VARC 172 and VARC 273 guidelines. Clinical follow-up will extend through 1 year. \\\\\nThe primary endpoint was achieved in 10/10 subjects in Cohort A108 and 5/7 in Cohort B (in 1 subject a valve was not implanted and in 1 subject a valve was implanted using the current Lotus Valve System). Table 4.15 shows core lab analyses of prosthetic valve performance as assessed by TTE for the 2 cohorts. In both cohorts, mean aortic valve area and mean gradient improved at discharge and remained improved at 30 days. There were no cases of moderate or severe PVR at discharge or 30 days in either cohort. Table 4.16 shows rates of CEC-adjudicated VARCdefined events during the index procedure, through discharge/7 days, and to 30 days. In Cohort A, one subject experienced the majority of events and subsequently died on day 13 post implant. In Cohort B, events were minimal. In summary, acute and 30-day outcomes in the REPRISE NG DS study demonstrate acceptable performance and safety of the LOTUS Edge System. \\\\\nAdded new Table 4.1-5 and new Table 4.1-6.\n\\end{tabular} & \\\\\n\\hline 4.2 Justification for the Study & As noted above, the Lotus Valve System potentially provides a number... The anticipated risks and benefits associated both with the Lotus Valve System and with participation... The conclusion of this risk-benefit analysis demonstrates that the known risks & As noted above, the Lotus Valve System and LOTUS Edge Valve System potentially provide a number... The anticipated risks and benefits associated both with the Lotus Valve System/LOTUS Edge Valve System and with participation... & Updated to include the 29 mm LOTUS Edge Nested Registry 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Modification","confidence":1,"confidence_rate":1},{"cnt":[[1374,499],[2212,499],[2212,1657],[1374,1657]],"region":{"top_left_x":1374,"top_left_y":498,"width":839,"height":1160},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3a26e442a085438fbabb906adfab28ea","type":"complex_cell","conversion_output":false,"parent_id":"4745ec721c8b4521a4b2411644f70c7b","children_ids":["065541f45d1e4287b809d6dd89a62228","9e5d5f2fad0a4604bf4ba73a188cfb06","640fb765002a4a82b7babeb0cf7374fd","1db57b99b3bb4340b505b03f851c0110","40be0774617c4f7e80c7ceba2aca92a7","6d07b1d5fd0643bba05ccd70b0133c0c","765a6fede1e34692a2566b285164de82","a9eb2520b7204c3da02a28e8ded5be6d","bb4a13e957684666b9700862084b2330","96a59fb0dd2d462d83fd727bfd16755b","81587213d8ab4493a9e43a12fa9121a6","a24f9bd23ec74ee2b4f8af9cde6d8327","4d525b1ac157420b9a54dae26e2a2e4a","a2248ab95ec14329bf4192fec53302a8","4d99b4fe9f7e4b4aab862deccd4609a3","79bd27f4fde146ab9362c933a8b6bd5b","a4bcc1b3af314634ac49fc6893308926","6350f8687eca48e19695a1db4a8a6a87","fc07d47fd7bd4c69badb67131b73056b","1a0c9268102748fe9f0588fe71de3e73","d8fe55eb56944c9c9bc74f14bef9d6ca","0cc735a027f64290823569e1d6f011bd","838e0dd823c847f6996eae1c5f879c47","31c918d61a48423299f4e457d70c21f3","2d0d352e7d7a45a4bddc256e7b2de663","8adbb74ad13c433191429ffe2240bdf3","6740ce6453944b8fb2a09acbbb39e338","86c87f1a24c74b96b9a07294fcc96441","28986eec5929404590618f46d7b49ec7","c03924365a4242c383ec7af6396f8a31","c7b3d454e2b7452bb13ae003603c97a3","65071c3a0d8e4ba195e37a9953e37dda"],"text":"\\begin{tabular}{l}\nenrolled at the same centers to evaluate acute performance and safety of a further optimized version of the LOTUS Edge device (including radiopaque markers on the valve locking assembly). Cohort B also assessed the acute performance and safety of an early iteration of the iSleeve Introducer Set and its compatibility with the LOTUS Edge device. Device sizes evaluated included the \\(23 mm, 25 mm\\) and 27 mm . The primary endpoint of the study was technical success, defined as follows: successful vascular access, delivery and deployment of the Lotus valve and successful retrieval with the LOTUS Edge delivery system; correct positioning of the Lotus valve in the proper anatomical location; and only one Lotus valve implanted in the proper anatomical location. Other measurements incorporated data collection and endpoints recommended and defined by the VARC 172 and VARC 273 guidelines. Clinical follow-up will extend through 1 year. \\\\\nThe primary endpoint was achieved in 10/10 subjects in Cohort A108 and 5/7 in Cohort B (in 1 subject a valve was not implanted and in 1 subject a valve was implanted using the current Lotus Valve System). Table 4.15 shows core lab analyses of prosthetic valve performance as assessed by TTE for the 2 cohorts. In both cohorts, mean aortic valve area and mean gradient improved at discharge and remained improved at 30 days. There were no cases of moderate or severe PVR at discharge or 30 days in either cohort. Table 4.16 shows rates of CEC-adjudicated VARCdefined events during the index procedure, through discharge/7 days, and to 30 days. In Cohort A, one subject experienced the majority of events and subsequently died on day 13 post implant. In Cohort B, events were minimal. In summary, acute and 30-day outcomes in the REPRISE NG DS study demonstrate acceptable performance and safety of the LOTUS Edge System. \\\\\nAdded new Table 4.1-5 and new Table 4.1-6.\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nenrolled at the same centers to evaluate acute performance and safety of a further optimized version of the LOTUS Edge device (including radiopaque markers on the valve locking assembly). Cohort B also assessed the acute performance and safety of an early iteration of the iSleeve Introducer Set and its compatibility with the LOTUS Edge device. Device sizes evaluated included the \\(23 mm, 25 mm\\) and 27 mm . The primary endpoint of the study was technical success, defined as follows: successful vascular access, delivery and deployment of the Lotus valve and successful retrieval with the LOTUS Edge delivery system; correct positioning of the Lotus valve in the proper anatomical location; and only one Lotus valve implanted in the proper anatomical location. Other measurements incorporated data collection and endpoints recommended and defined by the VARC 172 and VARC 273 guidelines. Clinical follow-up will extend through 1 year. \\\\\nThe primary endpoint was achieved in 10/10 subjects in Cohort A108 and 5/7 in Cohort B (in 1 subject a valve was not implanted and in 1 subject a valve was implanted using the current Lotus Valve System). Table 4.15 shows core lab analyses of prosthetic valve performance as assessed by TTE for the 2 cohorts. In both cohorts, mean aortic valve area and mean gradient improved at discharge and remained improved at 30 days. There were no cases of moderate or severe PVR at discharge or 30 days in either cohort. Table 4.16 shows rates of CEC-adjudicated VARCdefined events during the index procedure, through discharge/7 days, and to 30 days. In Cohort A, one subject experienced the majority of events and subsequently died on day 13 post implant. In Cohort B, events were minimal. In summary, acute and 30-day outcomes in the REPRISE NG DS study demonstrate acceptable performance and safety of the LOTUS Edge System. \\\\\nAdded new Table 4.1-5 and new Table 4.1-6.\n\\end{tabular}","cell_row":1,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":0.87255859375,"confidence_rate":0.9999327288013291},{"cnt":[[1379,503],[2169,503],[2169,540],[1379,540]],"region":{"top_left_x":1378,"top_left_y":502,"width":792,"height":38},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"065541f45d1e4287b809d6dd89a62228","type":"text","conversion_output":false,"parent_id":"3a26e442a085438fbabb906adfab28ea","text":"enrolled at the same centers to evaluate acute performance and","text_display":"enrolled at the same centers to evaluate acute performance and","confidence":1,"confidence_rate":1},{"cnt":[[1379,538],[2191,538],[2191,574],[1379,574]],"region":{"top_left_x":1378,"top_left_y":537,"width":813,"height":38},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9e5d5f2fad0a4604bf4ba73a188cfb06","type":"text","conversion_output":false,"parent_id":"3a26e442a085438fbabb906adfab28ea","text":"safety of a further optimized version of the LOTUS Edge device","text_display":" safety of a further optimized version of the LOTUS Edge device","confidence":1,"confidence_rate":1},{"cnt":[[1379,572],[2169,572],[2169,611],[1379,611]],"region":{"top_left_x":1378,"top_left_y":572,"width":792,"height":40},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"640fb765002a4a82b7babeb0cf7374fd","type":"text","conversion_output":false,"parent_id":"3a26e442a085438fbabb906adfab28ea","text":"(including radiopaque markers on the valve locking assembly).","text_display":" (including radiopaque markers on the valve locking assembly).","confidence":1,"confidence_rate":1},{"cnt":[[1379,611],[2165,611],[2165,648],[1379,648]],"region":{"top_left_x":1378,"top_left_y":611,"width":787,"height":38},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1db57b99b3bb4340b505b03f851c0110","type":"text","conversion_output":false,"parent_id":"3a26e442a085438fbabb906adfab28ea","text":"Cohort B also assessed the acute performance and safety of an","text_display":" Cohort B also assessed the acute performance and safety of an","confidence":1,"confidence_rate":1},{"cnt":[[1379,646],[2191,646],[2191,683],[1379,683]],"region":{"top_left_x":1378,"top_left_y":645,"width":813,"height":38},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"40be0774617c4f7e80c7ceba2aca92a7","type":"text","conversion_output":false,"parent_id":"3a26e442a085438fbabb906adfab28ea","text":"early iteration of the iSleeve Introducer Set and its compatibility","text_display":" early iteration of the iSleeve Introducer Set and its compatibility","confidence":1,"confidence_rate":1},{"cnt":[[1379,681],[2173,681],[2173,717],[1379,717]],"region":{"top_left_x":1378,"top_left_y":680,"width":796,"height":38},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6d07b1d5fd0643bba05ccd70b0133c0c","type":"text","conversion_output":false,"parent_id":"3a26e442a085438fbabb906adfab28ea","text":"with the LOTUS Edge device. Device sizes evaluated included","text_display":" with the LOTUS Edge device. Device sizes evaluated included","confidence":1,"confidence_rate":1},{"cnt":[[1379,717],[2191,717],[2191,756],[1379,756]],"region":{"top_left_x":1378,"top_left_y":717,"width":813,"height":40},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"765a6fede1e34692a2566b285164de82","type":"text","conversion_output":false,"parent_id":"3a26e442a085438fbabb906adfab28ea","text":"the \\(23 mm, 25 mm\\) and 27 mm . The primary endpoint of the study","text_display":" the \\(23 mm, 25 mm\\) and 27 mm . The primary endpoint of the study","confidence":1,"confidence_rate":1},{"cnt":[[1379,754],[2160,754],[2160,791],[1379,791]],"region":{"top_left_x":1378,"top_left_y":754,"width":783,"height":37},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a9eb2520b7204c3da02a28e8ded5be6d","type":"text","conversion_output":false,"parent_id":"3a26e442a085438fbabb906adfab28ea","text":"was technical success, defined as follows: successful vascular","text_display":" was technical success, defined as follows: successful vascular","confidence":1,"confidence_rate":1},{"cnt":[[1379,789],[2078,789],[2078,826],[1379,826]],"region":{"top_left_x":1378,"top_left_y":788,"width":701,"height":38},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bb4a13e957684666b9700862084b2330","type":"text","conversion_output":false,"parent_id":"3a26e442a085438fbabb906adfab28ea","text":"access, delivery and deployment of the Lotus valve and","text_display":" access, delivery and deployment of the Lotus valve and","confidence":1,"confidence_rate":1},{"cnt":[[1379,826],[2128,826],[2128,862],[1379,862]],"region":{"top_left_x":1378,"top_left_y":825,"width":750,"height":38},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"96a59fb0dd2d462d83fd727bfd16755b","type":"text","conversion_output":false,"parent_id":"3a26e442a085438fbabb906adfab28ea","text":"successful retrieval with the LOTUS Edge delivery system;","text_display":" successful retrieval with the LOTUS Edge delivery system;","confidence":1,"confidence_rate":1},{"cnt":[[1379,862],[2169,862],[2169,899],[1379,899]],"region":{"top_left_x":1378,"top_left_y":862,"width":792,"height":38},"line":39,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"81587213d8ab4493a9e43a12fa9121a6","type":"text","conversion_output":false,"parent_id":"3a26e442a085438fbabb906adfab28ea","text":"correct positioning of the Lotus valve in the proper anatomical","text_display":" correct positioning of the Lotus valve in the proper anatomical","confidence":1,"confidence_rate":1},{"cnt":[[1379,897],[2121,897],[2121,934],[1379,934]],"region":{"top_left_x":1378,"top_left_y":897,"width":744,"height":37},"line":40,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a24f9bd23ec74ee2b4f8af9cde6d8327","type":"text","conversion_output":false,"parent_id":"3a26e442a085438fbabb906adfab28ea","text":"location; and only one Lotus valve implanted in the proper","text_display":" location; and only one Lotus valve implanted in the proper","confidence":0.99951171875,"confidence_rate":0.9999922476411908},{"cnt":[[1379,932],[2130,932],[2130,969],[1379,969]],"region":{"top_left_x":1378,"top_left_y":931,"width":753,"height":38},"line":41,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4d525b1ac157420b9a54dae26e2a2e4a","type":"text","conversion_output":false,"parent_id":"3a26e442a085438fbabb906adfab28ea","text":"anatomical location. Other measurements incorporated data","text_display":" anatomical location. Other measurements incorporated data","confidence":1,"confidence_rate":1},{"cnt":[[1379,971],[2117,971],[2117,1008],[1379,1008]],"region":{"top_left_x":1378,"top_left_y":970,"width":740,"height":38},"line":42,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a2248ab95ec14329bf4192fec53302a8","type":"text","conversion_output":false,"parent_id":"3a26e442a085438fbabb906adfab28ea","text":"collection and endpoints recommended and defined by the","text_display":" collection and endpoints recommended and defined by the","confidence":1,"confidence_rate":1},{"cnt":[[1379,1005],[2169,1005],[2169,1042],[1379,1042]],"region":{"top_left_x":1378,"top_left_y":1005,"width":792,"height":38},"line":43,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4d99b4fe9f7e4b4aab862deccd4609a3","type":"text","conversion_output":false,"parent_id":"3a26e442a085438fbabb906adfab28ea","text":"VARC 172 and VARC 273 guidelines. Clinical follow-up will","text_display":" VARC 172 and VARC 273 guidelines. Clinical follow-up will","confidence":1,"confidence_rate":1},{"cnt":[[1379,1040],[1667,1040],[1667,1077],[1379,1077]],"region":{"top_left_x":1378,"top_left_y":1039,"width":289,"height":38},"line":44,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"79bd27f4fde146ab9362c933a8b6bd5b","type":"text","conversion_output":false,"parent_id":"3a26e442a085438fbabb906adfab28ea","text":"extend through 1 year.","text_display":" extend through 1 year.","confidence":1,"confidence_rate":1},{"cnt":[[1379,1079],[2182,1079],[2182,1118],[1379,1118]],"region":{"top_left_x":1378,"top_left_y":1078,"width":805,"height":40},"line":45,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a4bcc1b3af314634ac49fc6893308926","type":"text","conversion_output":false,"parent_id":"3a26e442a085438fbabb906adfab28ea","text":"The primary endpoint was achieved in 10/10 subjects in Cohort","text_display":"\nThe primary endpoint was achieved in 10/10 subjects in Cohort","confidence":0.998046875,"confidence_rate":0.999970378698783},{"cnt":[[1379,1118],[2208,1118],[2208,1155],[1379,1155]],"region":{"top_left_x":1378,"top_left_y":1117,"width":831,"height":38},"line":46,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6350f8687eca48e19695a1db4a8a6a87","type":"text","conversion_output":false,"parent_id":"3a26e442a085438fbabb906adfab28ea","text":"A108 and 5/7 in Cohort B (in 1 subject a valve was not implanted","text_display":" A108 and 5/7 in Cohort B (in 1 subject a valve was not implanted","confidence":0.9980475902557373,"confidence_rate":0.9999728570603122},{"cnt":[[1379,1153],[2169,1153],[2169,1189],[1379,1189]],"region":{"top_left_x":1378,"top_left_y":1152,"width":792,"height":38},"line":47,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"fc07d47fd7bd4c69badb67131b73056b","type":"text","conversion_output":false,"parent_id":"3a26e442a085438fbabb906adfab28ea","text":"and in 1 subject a valve was implanted using the current Lotus","text_display":" and in 1 subject a valve was implanted using the current Lotus","confidence":1,"confidence_rate":1},{"cnt":[[1379,1187],[2199,1187],[2199,1224],[1379,1224]],"region":{"top_left_x":1378,"top_left_y":1187,"width":822,"height":38},"line":48,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1a0c9268102748fe9f0588fe71de3e73","type":"text","conversion_output":false,"parent_id":"3a26e442a085438fbabb906adfab28ea","text":"Valve System). Table 4.15 shows core lab analyses of prosthetic","text_display":" Valve System). Table 4.15 shows core lab analyses of prosthetic","confidence":1,"confidence_rate":1},{"cnt":[[1379,1224],[2191,1224],[2191,1263],[1379,1263]],"region":{"top_left_x":1378,"top_left_y":1224,"width":813,"height":40},"line":49,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d8fe55eb56944c9c9bc74f14bef9d6ca","type":"text","conversion_output":false,"parent_id":"3a26e442a085438fbabb906adfab28ea","text":"valve performance as assessed by TTE for the 2 cohorts. In both","text_display":" valve performance as assessed by TTE for the 2 cohorts. In both","confidence":1,"confidence_rate":1},{"cnt":[[1379,1261],[2173,1261],[2173,1298],[1379,1298]],"region":{"top_left_x":1378,"top_left_y":1260,"width":796,"height":38},"line":50,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0cc735a027f64290823569e1d6f011bd","type":"text","conversion_output":false,"parent_id":"3a26e442a085438fbabb906adfab28ea","text":"cohorts, mean aortic valve area and mean gradient improved at","text_display":" cohorts, mean aortic valve area and mean gradient improved at","confidence":1,"confidence_rate":1},{"cnt":[[1379,1296],[2139,1296],[2139,1332],[1379,1332]],"region":{"top_left_x":1378,"top_left_y":1295,"width":761,"height":38},"line":51,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"838e0dd823c847f6996eae1c5f879c47","type":"text","conversion_output":false,"parent_id":"3a26e442a085438fbabb906adfab28ea","text":"discharge and remained improved at 30 days. There were no","text_display":" discharge and remained improved at 30 days. There were no","confidence":1,"confidence_rate":1},{"cnt":[[1379,1330],[2208,1330],[2208,1367],[1379,1367]],"region":{"top_left_x":1378,"top_left_y":1330,"width":831,"height":37},"line":52,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"31c918d61a48423299f4e457d70c21f3","type":"text","conversion_output":false,"parent_id":"3a26e442a085438fbabb906adfab28ea","text":"cases of moderate or severe PVR at discharge or 30 days in either","text_display":" cases of moderate or severe PVR at discharge or 30 days in either","confidence":1,"confidence_rate":1},{"cnt":[[1379,1365],[2139,1365],[2139,1406],[1379,1406]],"region":{"top_left_x":1378,"top_left_y":1364,"width":761,"height":42},"line":53,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2d0d352e7d7a45a4bddc256e7b2de663","type":"text","conversion_output":false,"parent_id":"3a26e442a085438fbabb906adfab28ea","text":"cohort. Table 4.16 shows rates of CEC-adjudicated VARC-","text_display":" cohort. Table 4.16 shows rates of CEC-adjudicated VARC","confidence":1,"confidence_rate":1},{"cnt":[[1379,1404],[2178,1404],[2178,1441],[1379,1441]],"region":{"top_left_x":1378,"top_left_y":1403,"width":800,"height":38},"line":54,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8adbb74ad13c433191429ffe2240bdf3","type":"text","conversion_output":false,"parent_id":"3a26e442a085438fbabb906adfab28ea","text":"defined events during the index procedure, through discharge/7","text_display":"defined events during the index procedure, through discharge/7","confidence":0.9990234375,"confidence_rate":0.9999854174250159},{"cnt":[[1379,1438],[2169,1438],[2169,1475],[1379,1475]],"region":{"top_left_x":1378,"top_left_y":1438,"width":792,"height":38},"line":55,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6740ce6453944b8fb2a09acbbb39e338","type":"text","conversion_output":false,"parent_id":"3a26e442a085438fbabb906adfab28ea","text":"days, and to 30 days. In Cohort A, one subject experienced the","text_display":" days, and to 30 days. 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Section Modified & Text as Written in REPRISE III Protocol Version AH & Text as Written in REPRISE III Protocol Version AI & Justification for Modification \\\\\n\\hline & associated with the procedure, and specifically the use of the Lotus Valve System, have been mitigated… out-weigh the risks. & \\begin{tabular}{l}\nThe conclusion of this risk-benefit analysis demonstrates that the known risks associated with the procedure, and specifically the use of the Lotus Valve System/LOTUS Edge Valve System, have been mitigated... out-weigh the risks. \\\\\nNo new hazards/harms are introduced by the 29 mm LOTUS Edge Valve System compared to the \\(21 mm, 23 mm, 25 mm\\) and 27 mm Lotus Valve System when used with the Lotus Introducer Set. Since the overall risk profile of the device has not changed, it can be concluded that the potential benefits of the use of the 29 mm LOTUS Edge Valve System with the Lotus Introducer Set out-weigh the risks.\n\\end{tabular} & \\multirow{3}{*}{} \\\\\n\\hline 5. Device Description & The study devices… replacement. Every subject... The control device in the planned... & The study devices... replacement. Test devices include the Lotus \\({ }^{\\text {TM }}\\) Valve System available in valve sizes of \\(21 mm, 23 mm\\), 25 mm , and 27 mm diameter, and the LOTUS Edge \\({ }^{\\text {TM }}\\) Valve System available in a valve size of 29 mm diameter (Section 5.1). Every subject... The control device (Section 5.2) in the planned... & \\\\\n\\hline 5.1 LOTUS Valve System Investigational Device (Test) & \\begin{tabular}{l}\n5.1 LOTUS Valve System Investigational Device (Test) \\\\\nThe Lotus Valve System (Figure 5.1-1) has two... \\\\\n...into the aortic vessel. Device sizes used in the randomized cohort include \\(23 mm, 25 mm\\), and 27 mm diameter. Devices in the Lotus 21 mm Nested Registry cohort are 21 mm in diameter. More detailed product information is contained in the Investigator Brochure and Instructions For Use (IFU). \\\\\nFigure 5.1 1: Lotus \\({ }^{\\text {TM }}\\) Valve System 5.1.1 Lotus Valve \\\\\nThe Lotus Valve (Figure 5.1 2) consists of... ...locking mechanism.\n\\end{tabular} & \\begin{tabular}{l}\n5.1 LOTUS Valve System and LOTUS Edge Valve System Investigational Devices (Test) \\\\\nThe Lotus Valve System and LOTUS Edge Valve System (Figure 5.1-1) have two... \\\\\n...into the aortic vessel. Lotus Valve System device sizes used in the randomized cohort and the U.S. Continued Access Study cohort include \\(23 mm, 25 mm\\), and 27 mm diameter. Devices in the Lotus 21 mm Nested Registry cohort are 21 mm in diameter. The LOTUS Edge Valve System is a design iteration of the Lotus Valve System. Devices in the LOTUS Edge 29 mm Nested Registry cohort are 29 mm in diameter. More detailed product information is contained in the Investigator Brochure and Instructions For Use (IFU) for both devices. \\\\\nFigure 5.1 1: Lotus \\({ }^{\\text {™ }}\\) Valve System and LOTUS Edge™ Valve System \\\\\n5.1.1 Lotus Valve and LOTUS Edge Valve \\\\\nThe Lotus Valve and LOTUS Edge Valve (Figure 5.1 2) consist\n\\end{tabular} & \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Table 27.1-8: Table of Changes for REPRISE III Protocol Version AI (Compared to REPRISE III Protocol Version AH)}\n\\begin{tabular}{|l|l|l|l|}\n\\hline Section Modified & Text as Written in REPRISE III Protocol Version AH & Text as Written in REPRISE III Protocol Version AI & Justification for Modification \\\\\n\\hline & associated with the procedure, and specifically the use of the Lotus Valve System, have been mitigated… out-weigh the risks. & \\begin{tabular}{l}\nThe conclusion of this risk-benefit analysis demonstrates that the known risks associated with the procedure, and specifically the use of the Lotus Valve System/LOTUS Edge Valve System, have been mitigated... out-weigh the risks. \\\\\nNo new hazards/harms are introduced by the 29 mm LOTUS Edge Valve System compared to the \\(21 mm, 23 mm, 25 mm\\) and 27 mm Lotus Valve System when used with the Lotus Introducer Set. Since the overall risk profile of the device has not changed, it can be concluded that the potential benefits of the use of the 29 mm LOTUS Edge Valve System with the Lotus Introducer Set out-weigh the risks.\n\\end{tabular} & \\multirow{3}{*}{} \\\\\n\\hline 5. Device Description & The study devices… replacement. Every subject... The control device in the planned... & The study devices... replacement. Test devices include the Lotus \\({ }^{\\text {TM }}\\) Valve System available in valve sizes of \\(21 mm, 23 mm\\), 25 mm , and 27 mm diameter, and the LOTUS Edge \\({ }^{\\text {TM }}\\) Valve System available in a valve size of 29 mm diameter (Section 5.1). Every subject... The control device (Section 5.2) in the planned... & \\\\\n\\hline 5.1 LOTUS Valve System Investigational Device (Test) & \\begin{tabular}{l}\n5.1 LOTUS Valve System Investigational Device (Test) \\\\\nThe Lotus Valve System (Figure 5.1-1) has two... \\\\\n...into the aortic vessel. Device sizes used in the randomized cohort include \\(23 mm, 25 mm\\), and 27 mm diameter. Devices in the Lotus 21 mm Nested Registry cohort are 21 mm in diameter. More detailed product information is contained in the Investigator Brochure and Instructions For Use (IFU). \\\\\nFigure 5.1 1: Lotus \\({ }^{\\text {TM }}\\) Valve System 5.1.1 Lotus Valve \\\\\nThe Lotus Valve (Figure 5.1 2) consists of... ...locking mechanism.\n\\end{tabular} & \\begin{tabular}{l}\n5.1 LOTUS Valve System and LOTUS Edge Valve System Investigational Devices (Test) \\\\\nThe Lotus Valve System and LOTUS Edge Valve System (Figure 5.1-1) have two... \\\\\n...into the aortic vessel. Lotus Valve System device sizes used in the randomized cohort and the U.S. Continued Access Study cohort include \\(23 mm, 25 mm\\), and 27 mm diameter. Devices in the Lotus 21 mm Nested Registry cohort are 21 mm in diameter. The LOTUS Edge Valve System is a design iteration of the Lotus Valve System. Devices in the LOTUS Edge 29 mm Nested Registry cohort are 29 mm in diameter. 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The device is designed to produce a final diameter of 21 mm , \\(23 mm, 25 mm\\), or 27 mm (depending on valve size) when the valve is locked. In the deployed state, the frame height of the 21 mm valve is approximately 15 mm ; the frame height of the three larger valve sizes is approximately 19 mm . \\\\\nFigure 5.1 2: Lotus Valve Implant \\\\\n5.1.2 Lotus Delivery System \\\\\nThe Lotus Delivery System is made of the catheter and the Lotus Controller. \\\\\n...inadvertent premature release. \\\\\n5.1.3 Lotus Introducer Set \\\\\nThe Lotus Introducer Set will be used as an accessory to the Lotus Valve System during the procedure.... for use in subjects requiring the 25 mm or 27 mm valve...\n\\end{tabular} & \\begin{tabular}{l}\nof... \\\\\n...locking mechanism. Additionally, the LOTUS Edge Valve has radiopaque tantalum markers on the valve locking assembly (i.e., buckle and post-top components) to aid in visualization of locking under fluoroscopy during the procedure. \\\\\n...The Lotus Valve device is designed to produce a final diameter of \\(21 mm, 23 mm, 25 mm\\), or 27 mm (depending on valve size) when the valve is locked. In the deployed state, the frame height of the 21 mm valve is approximately 15 mm ; the frame height of the three larger valve sizes is approximately 19 mm . The valve component of the 29 mm LOTUS Edge device is scaled from the \\(23 mm, 25 mm\\), and 27 mm valve sizes. Additionally, the LOTUS Edge 29 mm valve has a pad sewn between the braid and buckle to prevent interaction between the two components during sheathing and unsheathing of the valve. The frame height of the 29 mm valve in the deployed state is 21 mm . \\\\\nFigure 5.1 2: Lotus and LOTUS Edge Valve Implant 5.1.2 Lotus and LOTUS Edge Delivery System \\\\\nThe Lotus Valve and LOTUS Edge Valve have a Delivery System comprised of the catheter and the Lotus Controller. ...inadvertent premature release. \\\\\nOverall, the Delivery System for the LOTUS Edge Valve System is similar to that of the Lotus Valve System. Additionally, it has a modified leadscrew component, which results in a slightly decreased rate of retraction of the outer sheath during valve deployment compared to the Lotus Valve System. The multilumen catheter and outer sheath components of LOTUS Edge have been modified to enhance deliverability. \\\\\n5.1.3 Lotus Introducer Set \\\\\nThe Lotus Introducer Set will be used as an accessory to the Lotus Valve and LOTUS Edge Valve Systems during the procedure.... for use in subjects requiring the \\(25 mm, 27 mm\\), or 29 mm valve...\n\\end{tabular} & \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Table 27.1-8: Table of Changes for REPRISE III Protocol Version AI (Compared to REPRISE III Protocol Version AH)}\n\\begin{tabular}{|l|l|l|l|}\n\\hline Section Modified & Text as Written in REPRISE III Protocol Version AH & Text as Written in REPRISE III Protocol Version AI & Justification for Modification \\\\\n\\hline & \\begin{tabular}{l}\n... The device is designed to produce a final diameter of 21 mm , \\(23 mm, 25 mm\\), or 27 mm (depending on valve size) when the valve is locked. In the deployed state, the frame height of the 21 mm valve is approximately 15 mm ; the frame height of the three larger valve sizes is approximately 19 mm . \\\\\nFigure 5.1 2: Lotus Valve Implant \\\\\n5.1.2 Lotus Delivery System \\\\\nThe Lotus Delivery System is made of the catheter and the Lotus Controller. \\\\\n...inadvertent premature release. \\\\\n5.1.3 Lotus Introducer Set \\\\\nThe Lotus Introducer Set will be used as an accessory to the Lotus Valve System during the procedure.... for use in subjects requiring the 25 mm or 27 mm valve...\n\\end{tabular} & \\begin{tabular}{l}\nof... \\\\\n...locking mechanism. 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The frame height of the 29 mm valve in the deployed state is 21 mm . \\\\\nFigure 5.1 2: Lotus and LOTUS Edge Valve Implant 5.1.2 Lotus and LOTUS Edge Delivery System \\\\\nThe Lotus Valve and LOTUS Edge Valve have a Delivery System comprised of the catheter and the Lotus Controller. ...inadvertent premature release. \\\\\nOverall, the Delivery System for the LOTUS Edge Valve System is similar to that of the Lotus Valve System. Additionally, it has a modified leadscrew component, which results in a slightly decreased rate of retraction of the outer sheath during valve deployment compared to the Lotus Valve System. 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The device is designed to produce a final diameter of 21 mm , \\(23 mm, 25 mm\\), or 27 mm (depending on valve size) when the valve is locked. In the deployed state, the frame height of the 21 mm valve is approximately 15 mm ; the frame height of the three larger valve sizes is approximately 19 mm . \\\\\nFigure 5.1 2: Lotus Valve Implant \\\\\n5.1.2 Lotus Delivery System \\\\\nThe Lotus Delivery System is made of the catheter and the Lotus Controller. \\\\\n...inadvertent premature release. \\\\\n5.1.3 Lotus Introducer Set \\\\\nThe Lotus Introducer Set will be used as an accessory to the Lotus Valve System during the procedure.... for use in subjects requiring the 25 mm or 27 mm valve...\n\\end{tabular}","text_display":"\\begin{tabular}{l}\n... The device is designed to produce a final diameter of 21 mm , \\(23 mm, 25 mm\\), or 27 mm (depending on valve size) when the valve is locked. In the deployed state, the frame height of the 21 mm valve is approximately 15 mm ; the frame height of the three larger valve sizes is approximately 19 mm . \\\\\nFigure 5.1 2: Lotus Valve Implant \\\\\n5.1.2 Lotus Delivery System \\\\\nThe Lotus Delivery System is made of the catheter and the Lotus Controller. \\\\\n...inadvertent premature release. \\\\\n5.1.3 Lotus Introducer Set \\\\\nThe Lotus Introducer Set will be used as an accessory to the Lotus Valve System during the procedure.... for use in subjects requiring the 25 mm or 27 mm valve...\n\\end{tabular}","cell_row":1,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.9970703125,"confidence_rate":0.9999919499321053},{"cnt":[[517,548],[1329,548],[1329,587],[517,587]],"region":{"top_left_x":516,"top_left_y":548,"width":813,"height":40},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2968a612a03d41d0a6bc0e8de7c34b84","type":"text","conversion_output":false,"parent_id":"125b53338155411dae1615efd7782318","text":"... The device is designed to produce a final diameter of 21 mm ,","text_display":"... The device is designed to produce a final diameter of 21 mm ,","confidence":0.998046875,"confidence_rate":0.9999739332086006},{"cnt":[[515,583],[1303,583],[1303,622],[515,622]],"region":{"top_left_x":514,"top_left_y":583,"width":789,"height":40},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6645ec72cc364955b22ea9d4ec6f3d38","type":"text","conversion_output":false,"parent_id":"125b53338155411dae1615efd7782318","text":"\\(23 mm, 25 mm\\), or 27 mm (depending on valve size) when the","text_display":" \\(23 mm, 25 mm\\), or 27 mm (depending on valve size) when the","confidence":1,"confidence_rate":1},{"cnt":[[515,620],[1288,620],[1288,657],[515,657]],"region":{"top_left_x":514,"top_left_y":619,"width":774,"height":38},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"cab362e2b50046fb9b923ef3c5377398","type":"text","conversion_output":false,"parent_id":"125b53338155411dae1615efd7782318","text":"valve is locked. In the deployed state, the frame height of the","text_display":" valve is locked. In the deployed state, the frame height of the","confidence":1,"confidence_rate":1},{"cnt":[[515,655],[1292,655],[1292,691],[515,691]],"region":{"top_left_x":514,"top_left_y":654,"width":779,"height":38},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8f1dffba735e4da383d23312627341b9","type":"text","conversion_output":false,"parent_id":"125b53338155411dae1615efd7782318","text":"21 mm valve is approximately 15 mm ; the frame height of the","text_display":" 21 mm valve is approximately 15 mm ; the frame height of the","confidence":0.9970703125,"confidence_rate":0.9999586770871279},{"cnt":[[515,689],[1130,689],[1130,730],[515,730]],"region":{"top_left_x":514,"top_left_y":689,"width":616,"height":42},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e8f4c44e18fa444faccad3806aafa8d5","type":"text","conversion_output":false,"parent_id":"125b53338155411dae1615efd7782318","text":"three larger valve sizes is approximately 19 mm .","text_display":" three larger valve sizes is approximately 19 mm .","confidence":0.9990234375,"confidence_rate":0.9999834401430849},{"cnt":[[517,832],[978,832],[978,869],[517,869]],"region":{"top_left_x":516,"top_left_y":832,"width":463,"height":37},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a45699281a634231b97d09bb84706594","type":"text","conversion_output":false,"parent_id":"125b53338155411dae1615efd7782318","text":"Figure 5.1 2: Lotus Valve Implant","text_display":"\nFigure 5.1 2: Lotus Valve Implant","confidence":1,"confidence_rate":1},{"cnt":[[515,971],[896,971],[896,1008],[515,1008]],"region":{"top_left_x":514,"top_left_y":970,"width":382,"height":38},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"00cccdcca72d4955837f84255dd6198e","type":"text","conversion_output":false,"parent_id":"125b53338155411dae1615efd7782318","text":"5.1.2 Lotus Delivery System","text_display":"\n5.1.2 Lotus Delivery 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\\\\\n...locking mechanism. Additionally, the LOTUS Edge Valve has radiopaque tantalum markers on the valve locking assembly (i.e., buckle and post-top components) to aid in visualization of locking under fluoroscopy during the procedure. \\\\\n...The Lotus Valve device is designed to produce a final diameter of \\(21 mm, 23 mm, 25 mm\\), or 27 mm (depending on valve size) when the valve is locked. In the deployed state, the frame height of the 21 mm valve is approximately 15 mm ; the frame height of the three larger valve sizes is approximately 19 mm . The valve component of the 29 mm LOTUS Edge device is scaled from the \\(23 mm, 25 mm\\), and 27 mm valve sizes. Additionally, the LOTUS Edge 29 mm valve has a pad sewn between the braid and buckle to prevent interaction between the two components during sheathing and unsheathing of the valve. The frame height of the 29 mm valve in the deployed state is 21 mm . \\\\\nFigure 5.1 2: Lotus and LOTUS Edge Valve Implant 5.1.2 Lotus and LOTUS Edge Delivery System \\\\\nThe Lotus Valve and LOTUS Edge Valve have a Delivery System comprised of the catheter and the Lotus Controller. ...inadvertent premature release. \\\\\nOverall, the Delivery System for the LOTUS Edge Valve System is similar to that of the Lotus Valve System. Additionally, it has a modified leadscrew component, which results in a slightly decreased rate of retraction of the outer sheath during valve deployment compared to the Lotus Valve System. The multilumen catheter and outer sheath components of LOTUS Edge have been modified to enhance deliverability. \\\\\n5.1.3 Lotus Introducer Set \\\\\nThe Lotus Introducer Set will be used as an accessory to the Lotus Valve and LOTUS Edge Valve Systems during the procedure.... for use in subjects requiring the \\(25 mm, 27 mm\\), or 29 mm valve...\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nof... \\\\\n...locking mechanism. Additionally, the LOTUS Edge Valve has radiopaque tantalum markers on the valve locking assembly (i.e., buckle and post-top components) to aid in visualization of locking under fluoroscopy during the procedure. \\\\\n...The Lotus Valve device is designed to produce a final diameter of \\(21 mm, 23 mm, 25 mm\\), or 27 mm (depending on valve size) when the valve is locked. In the deployed state, the frame height of the 21 mm valve is approximately 15 mm ; the frame height of the three larger valve sizes is approximately 19 mm . The valve component of the 29 mm LOTUS Edge device is scaled from the \\(23 mm, 25 mm\\), and 27 mm valve sizes. Additionally, the LOTUS Edge 29 mm valve has a pad sewn between the braid and buckle to prevent interaction between the two components during sheathing and unsheathing of the valve. The frame height of the 29 mm valve in the deployed state is 21 mm . \\\\\nFigure 5.1 2: Lotus and LOTUS Edge Valve Implant 5.1.2 Lotus and LOTUS Edge Delivery System \\\\\nThe Lotus Valve and LOTUS Edge Valve have a Delivery System comprised of the catheter and the Lotus Controller. ...inadvertent premature release. \\\\\nOverall, the Delivery System for the LOTUS Edge Valve System is similar to that of the Lotus Valve System. Additionally, it has a modified leadscrew component, which results in a slightly decreased rate of retraction of the outer sheath during valve deployment compared to the Lotus Valve System. The multilumen catheter and outer sheath components of LOTUS Edge have been modified to enhance deliverability. \\\\\n5.1.3 Lotus Introducer Set \\\\\nThe Lotus Introducer Set will be used as an accessory to the Lotus Valve and LOTUS Edge Valve Systems during the procedure.... for use in subjects requiring the \\(25 mm, 27 mm\\), or 29 mm valve...\n\\end{tabular}","cell_row":1,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":0.9878436728891984,"confidence_rate":0.9999923672740388},{"cnt":[[1379,499],[1444,499],[1444,538],[1379,538]],"region":{"top_left_x":1378,"top_left_y":498,"width":66,"height":40},"line":43,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"859bce2e1ea1453ea56012f72bcc0a15","type":"text","conversion_output":false,"parent_id":"48c04fcfeb694ad9af519fa6b6ddfc52","text":"of...","text_display":"of...","confidence":1,"confidence_rate":1},{"cnt":[[1379,546],[2199,546],[2199,585],[1379,585]],"region":{"top_left_x":1378,"top_left_y":546,"width":822,"height":40},"line":44,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5cf6f5fdef3549eeb32c35f1a126b799","type":"text","conversion_output":false,"parent_id":"48c04fcfeb694ad9af519fa6b6ddfc52","text":"...locking mechanism. Additionally, the LOTUS Edge Valve has","text_display":"\n...locking mechanism. Additionally, the LOTUS Edge Valve has","confidence":1,"confidence_rate":1},{"cnt":[[1379,583],[2199,583],[2199,622],[1379,622]],"region":{"top_left_x":1378,"top_left_y":583,"width":822,"height":40},"line":45,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"677b03d599bf46d98215b9f033cc0d09","type":"text","conversion_output":false,"parent_id":"48c04fcfeb694ad9af519fa6b6ddfc52","text":"radiopaque tantalum markers on the valve locking assembly (i.e.,","text_display":" radiopaque tantalum markers on the valve locking assembly (i.e.,","confidence":0.99853515625,"confidence_rate":0.9999787550418731},{"cnt":[[1379,620],[2117,620],[2117,657],[1379,657]],"region":{"top_left_x":1378,"top_left_y":619,"width":740,"height":38},"line":46,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"288ef86b947e4733951df1b064e28262","type":"text","conversion_output":false,"parent_id":"48c04fcfeb694ad9af519fa6b6ddfc52","text":"buckle and post-top components) to aid in visualization of","text_display":" buckle and post-top components) to aid in visualization of","confidence":1,"confidence_rate":1},{"cnt":[[1379,655],[1989,655],[1989,696],[1379,696]],"region":{"top_left_x":1378,"top_left_y":654,"width":612,"height":42},"line":47,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0f1fd83a0d9d41a8bbb6850d139083be","type":"text","conversion_output":false,"parent_id":"48c04fcfeb694ad9af519fa6b6ddfc52","text":"locking under fluoroscopy during the procedure.","text_display":" locking under fluoroscopy during the procedure.","confidence":1,"confidence_rate":1},{"cnt":[[1379,702],[2208,702],[2208,739],[1379,739]],"region":{"top_left_x":1378,"top_left_y":702,"width":831,"height":37},"line":48,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a93bd431c2ae43c7a78507c5807904dc","type":"text","conversion_output":false,"parent_id":"48c04fcfeb694ad9af519fa6b6ddfc52","text":"...The Lotus Valve device is designed to produce a final diameter","text_display":"\n...The Lotus Valve device is designed to produce a final diameter","confidence":0.99951171875,"confidence_rate":0.9999930228743673},{"cnt":[[1379,737],[2180,737],[2180,774],[1379,774]],"region":{"top_left_x":1378,"top_left_y":736,"width":802,"height":38},"line":49,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d730a12d11a64397b59e79ed3ac5b0db","type":"text","conversion_output":false,"parent_id":"48c04fcfeb694ad9af519fa6b6ddfc52","text":"of \\(21 mm, 23 mm, 25 mm\\), or 27 mm (depending on valve size)","text_display":" of \\(21 mm, 23 mm, 25 mm\\), or 27 mm (depending on valve size)","confidence":1,"confidence_rate":1},{"cnt":[[1379,776],[2191,776],[2191,813],[1379,813]],"region":{"top_left_x":1378,"top_left_y":775,"width":813,"height":38},"line":50,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7c822009b36d4f8bba4226f8bae1f291","type":"text","conversion_output":false,"parent_id":"48c04fcfeb694ad9af519fa6b6ddfc52","text":"when the valve is locked. In the deployed state, the frame height","text_display":" when the valve is locked. 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The valve","text_display":" the three larger valve sizes is approximately 19 mm . 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Additionally, it has a","text_display":" is similar to that of the Lotus Valve System. Additionally, it has a","confidence":1,"confidence_rate":1},{"cnt":[[1379,1399],[2117,1399],[2117,1441],[1379,1441]],"region":{"top_left_x":1378,"top_left_y":1399,"width":740,"height":42},"line":66,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"29fe5a3ab60a487eb50814eec71e2e0a","type":"text","conversion_output":false,"parent_id":"48c04fcfeb694ad9af519fa6b6ddfc52","text":"modified leadscrew component, which results in a slightly","text_display":" modified leadscrew component, which results in a slightly","confidence":1,"confidence_rate":1},{"cnt":[[1379,1434],[2130,1434],[2130,1475],[1379,1475]],"region":{"top_left_x":1378,"top_left_y":1434,"width":753,"height":42},"line":67,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bd6397860b294eeebdd13827fe6446ac","type":"text","conversion_output":false,"parent_id":"48c04fcfeb694ad9af519fa6b6ddfc52","text":"decreased rate of retraction of the outer sheath during valve","text_display":" decreased rate of retraction of the outer sheath during valve","confidence":1,"confidence_rate":1},{"cnt":[[1379,1473],[2152,1473],[2152,1510],[1379,1510]],"region":{"top_left_x":1378,"top_left_y":1473,"width":774,"height":37},"line":68,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"60f71081e3cf4c19b6363bf1e5ccb3b6","type":"text","conversion_output":false,"parent_id":"48c04fcfeb694ad9af519fa6b6ddfc52","text":"deployment compared to the Lotus Valve System. 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The multi","confidence":1,"confidence_rate":1},{"cnt":[[1379,1508],[2156,1508],[2156,1547],[1379,1547]],"region":{"top_left_x":1378,"top_left_y":1507,"width":779,"height":40},"line":69,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c235f6de5ec746acb142ff5e528bafd2","type":"text","conversion_output":false,"parent_id":"48c04fcfeb694ad9af519fa6b6ddfc52","text":"lumen catheter and outer sheath components of LOTUS Edge","text_display":"lumen catheter and outer sheath components of LOTUS Edge","confidence":1,"confidence_rate":1},{"cnt":[[1379,1545],[1955,1545],[1955,1584],[1379,1584]],"region":{"top_left_x":1378,"top_left_y":1544,"width":577,"height":40},"line":70,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"07994d1e6081449691577741f95edbc8","type":"text","conversion_output":false,"parent_id":"48c04fcfeb694ad9af519fa6b6ddfc52","text":"have been modified to enhance deliverability.","text_display":" have been modified to enhance 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Section Modified & Text as Written in REPRISE III Protocol Version AH & Text as Written in REPRISE III Protocol Version AI & Justification for Modification \\\\\n\\hline 5.3.1 Test Device & The study Manual of Operations includes the IFU for the Lotus Valve System. Study devices... & The study Manual of Operations includes the IFU for the Lotus Valve System and the IFU for the LOTUS Edge Valve System. Study devices... & \\multirow{7}{*}{} \\\\\n\\hline 6. Objectives & The objective of the REPRISE III trial is to evaluate the safety and effectiveness of the Lotus \\({ }^{\\text {TM }}\\) Valve System for transcatheter... & The objective of the REPRISE III trial is to evaluate the safety and effectiveness of the Lotus \\({ }^{\\text {TM }}\\) Valve System and LOTUS Edge \\({ }^{\\text {TM }}\\) Valve System ( 29 mm valve) for transcatheter... & \\\\\n\\hline 7. Endpoints & Among the roll-in, Lotus 21 mm Nested Registry, and U.S. Continued Access Study cohorts, for ITT analyses... ...implanted with the Lotus valve. & \\begin{tabular}{l}\nAmong the roll-in, (initial cohort with \\(23 mm, 25 mm\\), and 27 mm Lotus Valve System and subsequent cohort with 29 mm LOTUS Edge Valve System), Lotus 21 mm Nested Registry, LOTUS Edge 29 mm Nested Registry, and U.S. Continued Access Study cohorts, for ITT analyses... \\\\\n...implanted with the Lotus/LOTUS Edge valve.\n\\end{tabular} & \\\\\n\\hline 8.1 Scale and Duration & ...who provide consent for participation are enrolled. & ...who provide consent for participation are enrolled. There will also be a non-randomized, roll-in phase with the 29 mm LOTUS Edge Valve for centers that do not have prior experience implanting the LOTUS Edge Valve System, and a nested registry cohort of subjects who will receive the 29 mm LOTUS Edge Valve System (LOTUS Edge 29 mm Nested Registry). Participating centers will be centers that have enrolled subjects in REPRISE III with the Lotus Valve System. & \\\\\n\\hline 8.2 Treatment Assignment & Note: ...to further assess performance and safety. & Note: ...to further assess performance and safety. There will also be a non-randomized, roll-in phase with the 29 mm LOTUS Edge Valve for centers that do not have previous experience implanting the LOTUS Edge Valve System (at least 2 roll-in cases/center), and a nested registry cohort of subjects who will receive the 29 mm LOTUS Edge Valve System (LOTUS Edge 29 mm Nested Registry). & \\\\\n\\hline 8.2.1 Treatment & The test device is the Lotus Valve System, which consists of a... & The test device is the Lotus Valve System or the LOTUS Edge Valve System, both of which consist of a... & \\\\\n\\hline 8.3 Study Design Justification & There will be up to 2052 subjects in REPRISE III. In order... 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Section Modified & Text as Written in REPRISE III Protocol Version AH & Text as Written in REPRISE III Protocol Version AI & Justification for Modification \\\\\n\\hline & & 29 mm Nested Registry. Up to... & \\multirow{7}{*}{} \\\\\n\\hline Table 9.2-1 & IC. \\(2 \\ldots\\) annulus size of \\(\\geq 18 mm\\) and \\(\\leq 27 mm\\)... & IC. 2 ... annulus size of \\(\\geq 18 mm\\) and \\(\\leq 29 mm\\)... & \\\\\n\\hline 10.1.1 Roll-in Subjects & ...insert the Lotus Valve System into the subject's femoral artery. & ...insert the Lotus Valve System (initial cohort with the 23 mm , 25 mm , and 27 mm Lotus Valve) into the subject's femoral artery. & \\\\\n\\hline 10.1.5 LOTUS Edge 29 mm Roll-in and Nested Registry Subjects & - & There will also be a non-randomized, roll-in phase with the 29 mm LOTUS Edge Valve for centers that do not have prior experience implanting the LOTUS Edge Valve System. Participating centers will be centers that have enrolled subjects in REPRISE III with the Lotus Valve System. For the LOTUS Edge 29 mm Roll-in cohort and Nested Registry, subjects confirmed eligible for the study by the CRC (see Section 22.2) and who provided written informed consent are considered enrolled in the study as soon as an attempt is made to insert the LOTUS Edge Valve System into the subject's femoral artery. & \\\\\n\\hline Figure 11.1-1 & - & Updated figure to include 29 mm Nested Registry and 29 mm rollin subjects. & \\\\\n\\hline 11.7.2.1 Valvuloplasty & \\begin{tabular}{l}\n...Prior to introduction of the Lotus Valve System, the subject's... \\\\\nNote: If the subject becomes hemodynamically unstable after the valvuloplasty for reasons unrelated to the aortic valve annulus and/or leaflets, the Lotus Valve implantation should…\n\\end{tabular} & \\begin{tabular}{l}\n...Prior to introduction of the Lotus Valve System or LOTUS Edge Valve System, the subject's... \\\\\nNote: If the subject becomes hemodynamically unstable after the valvuloplasty for reasons unrelated to the aortic valve annulus and/or leaflets, the Lotus Valve implantation (using the Lotus Valve System or the LOTUS Edge Valve System) should...\n\\end{tabular} & \\\\\n\\hline 11.7.2.2 Preparing... LOTUS... or LOTUS Edge Valve System & \\begin{tabular}{l}\nThe Lotus Valve implantation procedure requires... The Lotus Valve System must be prepared in accordance with the IFU. Device preparation should only be performed by persons who have completed appropriate training with the Lotus Valve. \\\\\nPrior to insertion of the Lotus Valve catheter... \\\\\nThe Lotus Valve System IFU should be followed. The following summarizes the Lotus Valve System procedure. \\\\\n1) The Lotus delivery catheter is... \\\\\n2) The Lotus catheter is...\n\\end{tabular} & \\begin{tabular}{l}\nThe Lotus Valve implantation procedure (using the Lotus Valve System or the LOTUS Edge Valve System) requires... The Lotus Valve System/LOTUS Edge Valve System must be prepared in accordance with the applicable IFU. Device preparation should only be performed by persons who have completed appropriate training with the Lotus Valve System or LOTUS Edge Valve System (as applicable). \\\\\nPrior to insertion of the Lotus Valve System/LOTUS Edge Valve System catheter... \\\\\nThe Lotus Valve System or LOTUS Edge Valve System IFU should be followed, as applicable. The following summarizes the\n\\end{tabular} & \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Table 27.1-8: Table of Changes for REPRISE III Protocol Version AI (Compared to REPRISE III Protocol Version AH)}\n\\begin{tabular}{|l|l|l|l|}\n\\hline Section Modified & Text as Written in REPRISE III Protocol Version AH & Text as Written in REPRISE III Protocol Version AI & Justification for Modification \\\\\n\\hline & & 29 mm Nested Registry. Up to... & \\multirow{7}{*}{} \\\\\n\\hline Table 9.2-1 & IC. \\(2 \\ldots\\) annulus size of \\(\\geq 18 mm\\) and \\(\\leq 27 mm\\)... & IC. 2 ... annulus size of \\(\\geq 18 mm\\) and \\(\\leq 29 mm\\)... & \\\\\n\\hline 10.1.1 Roll-in Subjects & ...insert the Lotus Valve System into the subject's femoral artery. & ...insert the Lotus Valve System (initial cohort with the 23 mm , 25 mm , and 27 mm Lotus Valve) into the subject's femoral artery. & \\\\\n\\hline 10.1.5 LOTUS Edge 29 mm Roll-in and Nested Registry Subjects & - & There will also be a non-randomized, roll-in phase with the 29 mm LOTUS Edge Valve for centers that do not have prior experience implanting the LOTUS Edge Valve System. Participating centers will be centers that have enrolled subjects in REPRISE III with the Lotus Valve System. 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Device preparation should only be performed by persons who have completed appropriate training with the Lotus Valve System or LOTUS Edge Valve System (as applicable). \\\\\nPrior to insertion of the Lotus Valve System/LOTUS Edge Valve System catheter... \\\\\nThe Lotus Valve System or LOTUS Edge Valve System IFU should be followed, as applicable. 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Section Modified & Text as Written in REPRISE III Protocol Version AH & Text as Written in REPRISE III Protocol Version AI & Justification for Modification \\\\\n\\hline & \\begin{tabular}{l}\nLabels from the devices used during the procedure (e.g., the Lotus Valve System, Lotus Introducer)... \\\\\nThe following information will be collected during the procedure... \\\\\n- Device size ( \\(21 mm, 23 mm, 25 mm, 27 mm\\) ) and model... \\\\\n- Lotus Valve catheter insertion and removal time... \\\\\n- Device deficiencies assessment (for the Lotus Valve System)\n\\end{tabular} & \\begin{tabular}{l}\nLotus Valve System/ LOTUS Edge Valve System procedure. \\\\\n1) The Lotus/LOTUS Edge delivery catheter is... \\\\\n2) The Lotus/LOTUS Edge catheter is... \\\\\nLabels from the devices used during the procedure (e.g., the Lotus Valve System/LOTUS Edge Valve System, Lotus Introducer)... \\\\\nThe following information will be collected during the procedure... \\\\\n- Device size ( \\(21 mm, 23 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Section Modified & Text as Written in REPRISE III Protocol Version AH & Text as Written in REPRISE III Protocol Version AI & Justification for Modification \\\\\n\\hline procedure Measurements & 21 mm Nested Registry, or... & \\(23 mm, 25 mm\\), or 27 mm Lotus Valve), Lotus 21 mm Nested Registry, roll-in with the 29 mm LOTUS Edge Valve, LOTUS Edge 29 mm Nested Registry, or... & \\multirow{7}{*}{} \\\\\n\\hline 12.2.1 Analysis Sets & ... Among the roll-in, Lotus 21 mm Nested Registry, and U.S. Continued Access Study cohorts, for ITT analyses... For these 3 cohorts, the as-treated population includes all subjects implanted with the Lotus Valve. The as-treated and implanted analysis sets are the same for these 3 cohorts. & ... Among the roll-in (with the \\(23 mm, 25 mm\\), or 27 mm Lotus Valve), Lotus 21 mm Nested Registry, roll-in with the 29 mm LOTUS Edge Valve, LOTUS Edge 29 mm Nested Registry, and U.S. Continued Access Study cohorts, for ITT analyses... For these cohorts, the as-treated population includes all subjects implanted with the Lotus Valve. The as-treated and implanted analysis sets are the same for these cohorts. & \\\\\n\\hline 12.2.4 Reporting Events & For all subjects in the roll-in, Lotus 21 mm Nested Registry, LOTUS Edge 29 mm Nested Registry, and.... & For all subjects in the roll-in, (with the \\(23 mm, 25 mm\\), or 27 mm Lotus Valve), Lotus 21 mm Nested Registry, roll-in with the 29 mm LOTUS Edge Valve, LOTUS Edge 29 mm Nested Registry, and.... & \\\\\n\\hline 12.3.2 Interim Analyses & ...completed their 30-day follow-up visits. & \\begin{tabular}{l}\n...completed their 30-day follow-up visits. \\\\\nThere will be an administrative analysis of 30-day data from implanted subjects receiving the LOTUS Edge 29 mm valve in the REPRISE III and the similarly designed REPRISE Edge 29 mm EU study. This analysis will be performed for regulatory agency review on the first 30 implanted subjects from the combined cohort and will be carried out after these pooled subjects have completed their 30 day follow-up visits.\n\\end{tabular} & \\\\\n\\hline 16.1 Investigational Device & The Lotus Valve System (investigational device)... The Lotus Valve System shall be securely maintained... Device Accountability Logs for the Lotus Valve System will be... & \\begin{tabular}{l}\nThe Lotus Valve System/LOTUS Edge Valve System (investigational device)... \\\\\nThe Lotus Valve System/LOTUS Edge Valve System shall be securely maintained... \\\\\nDevice Accountability Logs for the Lotus Valve System/LOTUS Edge Valve System will be...\n\\end{tabular} & \\\\\n\\hline 17.2 Investigator Responsibilities & - Complete all Lotus Valve (investigational device) training requirements as detailed in the REPRISE III Training Plan (see Section 17.4.1). & - Complete all Lotus Valve (investigational device) training requirements as detailed in the REPRISE III Training Plan (see Section 17.4.1). This includes training on the Lotus Valve System /LOTUS Edge Valve System as applicable. & \\\\\n\\hline 17.4.1 Training with the Lotus & The Sponsor is responsible for providing Investigators with the information and training on the Lotus Valve System they need... & The Sponsor is responsible for providing Investigators with the information and training on the Lotus Valve System/LOTUS & \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Table 27.1-8: Table of Changes for REPRISE III Protocol Version AI (Compared to REPRISE III Protocol Version AH)}\n\\begin{tabular}{|l|l|l|l|}\n\\hline Section Modified & Text as Written in REPRISE III Protocol Version AH & Text as Written in REPRISE III Protocol Version AI & Justification for Modification \\\\\n\\hline procedure Measurements & 21 mm Nested Registry, or... & \\(23 mm, 25 mm\\), or 27 mm Lotus Valve), Lotus 21 mm Nested Registry, roll-in with the 29 mm LOTUS Edge Valve, LOTUS Edge 29 mm Nested Registry, or... & \\multirow{7}{*}{} \\\\\n\\hline 12.2.1 Analysis Sets & ... 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Section Modified & Text as Written in REPRISE III Protocol Version AH & Text as Written in REPRISE III Protocol Version AI & Justification for Modification \\\\\n\\hline Valve System/ LOTUS Edge Valve System & Note: The training requirements listed above apply to centers that do not have previous experience implanting the Lotus Valve. 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For these Lotusexperienced investigators, at least 2 roll-in cases with the 29 mm LOTUS Edge Valve System will be performed before enrollment can commence in the LOTUS Edge 29 mm Nested Registry.\n\\end{tabular} & \\multirow{5}{*}{} \\\\\n\\hline 19.1 Risks... & \\begin{tabular}{l}\n...the use of the Lotus Valve System and/or CoreValve... \\\\\nAs the Lotus Valve is an investigational device...\n\\end{tabular} & \\begin{tabular}{l}\n...the use of the Lotus Valve System/LOTUS Edge Valve System and/or CoreValve... \\\\\nAs the Lotus Valve/LOTUS Edge Valve is an investigational device...\n\\end{tabular} & \\\\\n\\hline 19.2 Risk... & In addition…, the Lotus Valve System provides… & In addition…, the Lotus Valve System/LOTUS Edge Valve System provides... & \\\\\n\\hline \\begin{tabular}{l}\n19.3.2 \\\\\nPotential...\n\\end{tabular} & Potential benefits… use of the Lotus \\({ }^{\\text {TM }}\\) Valve System compared... & Potential benefits... use of the Lotus \\({ }^{\\text {TM }}\\) Valve System/LOTUS Edge \\({ }^{\\text {TM }}\\) Valve System compared... & \\\\\n\\hline 19.4 Risk to Benefit Rationale & ...which has been associated with long term mortality in TAVR. & ...which has been associated with long term mortality in TAVR. No new hazards/harms are introduced by the 29 mm LOTUS Edge Valve System compared to the 21, 23, 25 and 27 mm Lotus Valve System when used with the Lotus Introducer Set. Since and the overall risk profile of the device has not changed, it can be concluded that the potential benefits of the use of the 29 mm LOTUS Edge Valve System with the Lotus Introducer Set out- & \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Table 27.1-8: Table of Changes for REPRISE III Protocol Version AI (Compared to REPRISE III Protocol Version AH)}\n\\begin{tabular}{|l|l|l|l|}\n\\hline Section Modified & Text as Written in REPRISE III Protocol Version AH & Text as Written in REPRISE III Protocol Version AI & Justification for Modification \\\\\n\\hline Valve System/ LOTUS Edge Valve System & Note: The training requirements listed above apply to centers that do not have previous experience implanting the Lotus Valve. For these centers there will be a roll-in phase with at least 2 roll-in subjects per center treated under the supervision of a proctor. The roll-in subjects will count towards the 6 required proctored cases. & \\begin{tabular}{l}\nEdge Valve System they need... \\\\\nNote 1: The training requirements listed above apply to centers that do not have previous experience implanting the Lotus Valve. For these centers there will be a roll-in phase (initial cohort with the \\(23 mm, 25 mm\\), and 27 mm Lotus Valve System) with at least 2 roll-in subjects per center treated under the supervision of a proctor. The roll-in subjects will count towards the 6 required proctored cases. \\\\\nNote 2: Device training specific to the use of the 29 mm LOTUS Edge Valve System will be provided to investigators at participating centers prior to enrollment in the 29 mm roll-in cohort and LOTUS Edge 29 mm Nested Registry. 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For these Lotusexperienced investigators, at least 2 roll-in cases with the 29 mm LOTUS Edge Valve System will be performed before enrollment can commence in the LOTUS Edge 29 mm Nested Registry.\n\\end{tabular} & \\multirow{5}{*}{} \\\\\n\\hline 19.1 Risks... & \\begin{tabular}{l}\n...the use of the Lotus Valve System and/or CoreValve... \\\\\nAs the Lotus Valve is an investigational device...\n\\end{tabular} & \\begin{tabular}{l}\n...the use of the Lotus Valve System/LOTUS Edge Valve System and/or CoreValve... \\\\\nAs the Lotus Valve/LOTUS Edge Valve is an investigational device...\n\\end{tabular} & \\\\\n\\hline 19.2 Risk... & In addition…, the Lotus Valve System provides… & In addition…, the Lotus Valve System/LOTUS Edge Valve System provides... & \\\\\n\\hline \\begin{tabular}{l}\n19.3.2 \\\\\nPotential...\n\\end{tabular} & Potential benefits… use of the Lotus \\({ }^{\\text {TM }}\\) Valve System compared... & Potential benefits... use of the Lotus \\({ }^{\\text {TM }}\\) Valve System/LOTUS Edge \\({ }^{\\text {TM }}\\) Valve System compared... & \\\\\n\\hline 19.4 Risk to Benefit Rationale & ...which has been associated with long term mortality in TAVR. & ...which has been associated with long term mortality in TAVR. No new hazards/harms are introduced by the 29 mm LOTUS Edge Valve System compared to the 21, 23, 25 and 27 mm Lotus Valve System when used with the Lotus Introducer Set. Since and the overall risk profile of the device has not changed, it can be concluded that the potential benefits of the use of the 29 mm LOTUS Edge Valve System with the Lotus Introducer Set out- & 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Section Modified & Text as Written in REPRISE III Protocol Version AI & Text as Written in REPRISE III Protocol Version AJ & Justification for Modification \\\\\n\\hline & & Lotus Valve System. & \\multirow[t]{4}{*}{procedure with the Edge delivery system.} \\\\\n\\hline 2. Protocol Synopsis, Planned Subjects... & There will be up to 2092 subjects in REPRISE III. & \\begin{tabular}{l}\nThere will be up to 2142 subjects in REPRISE III. \\\\\n- At least 50 subjects will be enrolled in the LOTUS Edge Nested Registry ( \\(23 mm, 25 mm\\) and 27 mm valve sizes).\n\\end{tabular} & \\\\\n\\hline 2. Protocol Synopsis, Analysis Sets... & Among the roll-in (initial cohort with the \\(23 mm, 25 mm\\), and 27 mm Lotus), Lotus 21 mm Nested Registry, roll-in with the 29 mm LOTUS Edge, LOTUS Edge 29 mm Nested Registry, and… & Among the roll-in (initial cohort with the \\(23 mm, 25 mm\\), and 27 mm Lotus), Lotus 21 mm Nested Registry, LOTUS Edge Nested Registry, roll-in with the 29 mm LOTUS Edge, LOTUS Edge 29 mm Nested Registry, and... & \\\\\n\\hline 4. Introduction & With the Lotus Valve System as the test device, study subjects will be entered into the roll-in cohort, randomized (test versus control) cohort, a single-arm, nested registry cohort of subjects who receive the 21 mm Lotus Valve (Lotus 21 mm Nested Registry), or the U.S. Continued Access Study cohort (which will include a 4D computed tomography [CT] substudy cohort). Additionally, study subjects will be entered into a roll-in cohort and a single-arm, nested registry cohort of subjects who receive the 29 mm LOTUS Edge Valve System (LOTUS Edge 29 mm Nested Registry). Additional... & With the Lotus Valve System as the test device, study subjects will be entered into the roll-in cohort, randomized (test versus control) cohort, a single-arm, nested registry cohort of subjects who receive the 21 mm Lotus Valve (Lotus 21 mm Nested Registry), or the U.S. Continued Access Study cohort (which will include a 4D computed tomography [CT] substudy cohort). Study subjects will also be enrolled in a single-arm, nested registry with the 23, 25 and 27 mm LOTUS Edge Valve System (LOTUS Edge Nested Registry). Additionally, study subjects will be entered into a roll-in cohort and a single-arm, nested registry cohort of subjects who receive the 29 mm LOTUS Edge Valve System (LOTUS Edge 29 mm Nested Registry). & \\\\\n\\hline 4.1.1 Treatments for Aortic Stenosis & The REPRISE NG DS study recently completed enrollment in Australia, while the REPRISE Edge study is currently enrolling in Europe. & The REPRISE NG DS study recently completed enrollment in Australia, while the REPRISE Edge study is currently conducted in Europe. & Updated status of REPRISE Edge study. \\\\\n\\hline 4.1.4 REPRISE NG DS Study & \\begin{tabular}{l}\nCohort C completed enrollment in September 2016 with 21 subjects treated with the LOTUS Edge Valve System, which features a further refined version of the delivery system (results pending). \\\\\nThe primary endpoint was achieved in 10/10 subjects in Cohort A108 and 5/7 in Cohort B (in 1 subject a valve was not implanted and in 1 subject a valve was implanted using the current Lotus Valve System). Table 4.15 shows core lab analyses of prosthetic valve performance as assessed by TTE for the 2 cohorts. In both cohorts, mean aortic valve area and mean gradient improved at discharge and remained improved at 30 days. There were no\n\\end{tabular} & \\begin{tabular}{l}\nCohort C completed enrollment in September 2016 with 21 subjects treated with the LOTUS Edge Valve System, which features a further refined version of the delivery system, implanted with either the Lotus or improved expandable iSleeve Introducer. \\\\\n...In both cohorts, mean aortic valve area and mean gradient improved at discharge, and remained improved at 30 days and 1 year. There were no cases of moderate or severe PVR at discharge, or 30 days or 1-year in either cohort. Table 4.16 shows rates of CEC-adjudicated VARC-defined events during the index procedure, through discharge/7 days, and to 30 days and 1\n\\end{tabular} & Updated to add 1 year results from REPRISE NG DS Cohorts A and B, and outcomes from Cohort C through discharge and 30 days with the LOTUS Edge Valve System to support inclusion of the LOTUS Edge \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Table 27.1-9: Table of Changes for REPRISE III Protocol Version AJ (Compared to REPRISE III Protocol Version AI)}\n\\begin{tabular}{|l|l|l|l|}\n\\hline Section Modified & Text as Written in REPRISE III Protocol Version AI & Text as Written in REPRISE III Protocol Version AJ & Justification for Modification \\\\\n\\hline & & Lotus Valve System. & \\multirow[t]{4}{*}{procedure with the Edge delivery system.} \\\\\n\\hline 2. Protocol Synopsis, Planned Subjects... & There will be up to 2092 subjects in REPRISE III. & \\begin{tabular}{l}\nThere will be up to 2142 subjects in REPRISE III. \\\\\n- At least 50 subjects will be enrolled in the LOTUS Edge Nested Registry ( \\(23 mm, 25 mm\\) and 27 mm valve sizes).\n\\end{tabular} & \\\\\n\\hline 2. Protocol Synopsis, Analysis Sets... & Among the roll-in (initial cohort with the \\(23 mm, 25 mm\\), and 27 mm Lotus), Lotus 21 mm Nested Registry, roll-in with the 29 mm LOTUS Edge, LOTUS Edge 29 mm Nested Registry, and… & Among the roll-in (initial cohort with the \\(23 mm, 25 mm\\), and 27 mm Lotus), Lotus 21 mm Nested Registry, LOTUS Edge Nested Registry, roll-in with the 29 mm LOTUS Edge, LOTUS Edge 29 mm Nested Registry, and... & \\\\\n\\hline 4. Introduction & With the Lotus Valve System as the test device, study subjects will be entered into the roll-in cohort, randomized (test versus control) cohort, a single-arm, nested registry cohort of subjects who receive the 21 mm Lotus Valve (Lotus 21 mm Nested Registry), or the U.S. Continued Access Study cohort (which will include a 4D computed tomography [CT] substudy cohort). Additionally, study subjects will be entered into a roll-in cohort and a single-arm, nested registry cohort of subjects who receive the 29 mm LOTUS Edge Valve System (LOTUS Edge 29 mm Nested Registry). Additional... & With the Lotus Valve System as the test device, study subjects will be entered into the roll-in cohort, randomized (test versus control) cohort, a single-arm, nested registry cohort of subjects who receive the 21 mm Lotus Valve (Lotus 21 mm Nested Registry), or the U.S. Continued Access Study cohort (which will include a 4D computed tomography [CT] substudy cohort). Study subjects will also be enrolled in a single-arm, nested registry with the 23, 25 and 27 mm LOTUS Edge Valve System (LOTUS Edge Nested Registry). Additionally, study subjects will be entered into a roll-in cohort and a single-arm, nested registry cohort of subjects who receive the 29 mm LOTUS Edge Valve System (LOTUS Edge 29 mm Nested Registry). & \\\\\n\\hline 4.1.1 Treatments for Aortic Stenosis & The REPRISE NG DS study recently completed enrollment in Australia, while the REPRISE Edge study is currently enrolling in Europe. & The REPRISE NG DS study recently completed enrollment in Australia, while the REPRISE Edge study is currently conducted in Europe. & Updated status of REPRISE Edge study. \\\\\n\\hline 4.1.4 REPRISE NG DS Study & \\begin{tabular}{l}\nCohort C completed enrollment in September 2016 with 21 subjects treated with the LOTUS Edge Valve System, which features a further refined version of the delivery system (results pending). \\\\\nThe primary endpoint was achieved in 10/10 subjects in Cohort A108 and 5/7 in Cohort B (in 1 subject a valve was not implanted and in 1 subject a valve was implanted using the current Lotus Valve System). Table 4.15 shows core lab analyses of prosthetic valve performance as assessed by TTE for the 2 cohorts. In both cohorts, mean aortic valve area and mean gradient improved at discharge and remained improved at 30 days. There were no\n\\end{tabular} & \\begin{tabular}{l}\nCohort C completed enrollment in September 2016 with 21 subjects treated with the LOTUS Edge Valve System, which features a further refined version of the delivery system, implanted with either the Lotus or improved expandable iSleeve Introducer. \\\\\n...In both cohorts, mean aortic valve area and mean gradient improved at discharge, and remained improved at 30 days and 1 year. There were no cases of moderate or severe PVR at discharge, or 30 days or 1-year in either cohort. 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Table 4.16 shows rates of CEC-adjudicated VARCdefined events during the index procedure, through discharge/7 days, and to 30 days. In Cohort A, one subject experienced the majority of events and subsequently died on day 13 post implant. In Cohort B, events were minimal. In summary, acute and 30-day outcomes in the REPRISE NG DS study demonstrate acceptable performance and safety of the LOTUS Edge System. \\\\\nTable 4.1-5 and Table 4.1-6.\n\\end{tabular} & \\begin{tabular}{l}\nyear. In Cohort A, one subject experienced the majority of events and subsequently died on day 13 post implant. Another subject died on day 119; the primary cause of death was multiorgan failure, which was not considered related to the index procedure. In Cohort B, events were minimal through 1 year post implant. To date, acute and 30-day outcomes were sustained through 1 year in both cohorts. Overall, the results in Cohorts A and B of the REPRISE NG DS study demonstrate acceptable performance and safety of the LOTUS Edge System. Added 1 year results in Table 4.1-5 and Table 4.1-6. \\\\\nUsing the latest iteration of the LOTUS Edge Valve System with either the Lotus or expandable iSleeve Introducer, the primary endpoint was achieved in 21/21 subjects in Cohort C, which resulted in improved valve performance and no moderate or severe PVR at discharge/7 days and 30 days post implant (Table 4.1-7) based on echocardiographic core lab analysis. A summary of clinical outcomes through discharge/7 days and 30 days is presented in Table 4.1-8. There was no mortality. Disabling stroke occurred on day 0 in one subject. Only \\(2 / 21\\) subjects (9.5\\%) were implanted with a new permanent pacemaker (PPM) through 30 days post implant, which is lower than previously observed in studies with the Lotus Valve System. This may be attributed to the design of the LOTUS Edge delivery system with its flexibility and ability to minimize the depth of the valve frame during deployment within the annulus, thereby reducing the potential for unnecessary interaction with the left ventricular outflow tract and the conduction system of the heart. These outcomes in the REPRISE NG DS Cohort C subjects demonstrate acceptable performance and safety of the LOTUS Edge System through 30 days post implant. \\\\\nAdded Table 4.1-7 and Table 4.1-8.\n\\end{tabular} & Nested Registry. \\\\\n\\hline 4.2 Justification for the Study & No new hazards/harms are introduced by the 29 mm LOTUS Edge Valve System compared to the \\(21 mm, 23 mm, 25 mm\\) and 27 mm Lotus Valve System when used with the Lotus Introducer Set. Since the overall risk profile of the device has not changed, it & No new hazards/harms are introduced by the LOTUS Edge Valve System compared to the Lotus Valve System when used with the Lotus Introducer Set. Since the overall risk profile of the device has not changed, it can be concluded that the potential benefits of & Removed references specific to the 29 mm LOTUS Edge device since the text in these \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Table 27.1-9: Table of Changes for REPRISE III Protocol Version AJ (Compared to REPRISE III Protocol Version AI)}\n\\begin{tabular}{|l|l|l|l|}\n\\hline Section Modified & Text as Written in REPRISE III Protocol Version AI & Text as Written in REPRISE III Protocol Version AJ & Justification for Modification \\\\\n\\hline & \\begin{tabular}{l}\ncases of moderate or severe PVR at discharge or 30 days in either cohort. Table 4.16 shows rates of CEC-adjudicated VARCdefined events during the index procedure, through discharge/7 days, and to 30 days. In Cohort A, one subject experienced the majority of events and subsequently died on day 13 post implant. In Cohort B, events were minimal. In summary, acute and 30-day outcomes in the REPRISE NG DS study demonstrate acceptable performance and safety of the LOTUS Edge System. \\\\\nTable 4.1-5 and Table 4.1-6.\n\\end{tabular} & \\begin{tabular}{l}\nyear. In Cohort A, one subject experienced the majority of events and subsequently died on day 13 post implant. Another subject died on day 119; the primary cause of death was multiorgan failure, which was not considered related to the index procedure. In Cohort B, events were minimal through 1 year post implant. To date, acute and 30-day outcomes were sustained through 1 year in both cohorts. Overall, the results in Cohorts A and B of the REPRISE NG DS study demonstrate acceptable performance and safety of the LOTUS Edge System. Added 1 year results in Table 4.1-5 and Table 4.1-6. \\\\\nUsing the latest iteration of the LOTUS Edge Valve System with either the Lotus or expandable iSleeve Introducer, the primary endpoint was achieved in 21/21 subjects in Cohort C, which resulted in improved valve performance and no moderate or severe PVR at discharge/7 days and 30 days post implant (Table 4.1-7) based on echocardiographic core lab analysis. A summary of clinical outcomes through discharge/7 days and 30 days is presented in Table 4.1-8. There was no mortality. Disabling stroke occurred on day 0 in one subject. Only \\(2 / 21\\) subjects (9.5\\%) were implanted with a new permanent pacemaker (PPM) through 30 days post implant, which is lower than previously observed in studies with the Lotus Valve System. This may be attributed to the design of the LOTUS Edge delivery system with its flexibility and ability to minimize the depth of the valve frame during deployment within the annulus, thereby reducing the potential for unnecessary interaction with the left ventricular outflow tract and the conduction system of the heart. These outcomes in the REPRISE NG DS Cohort C subjects demonstrate acceptable performance and safety of the LOTUS Edge System through 30 days post implant. \\\\\nAdded Table 4.1-7 and Table 4.1-8.\n\\end{tabular} & Nested Registry. \\\\\n\\hline 4.2 Justification for the Study & No new hazards/harms are introduced by the 29 mm LOTUS Edge Valve System compared to the \\(21 mm, 23 mm, 25 mm\\) and 27 mm Lotus Valve System when used with the Lotus Introducer Set. Since the overall risk profile of the device has not changed, it & No new hazards/harms are introduced by the LOTUS Edge Valve System compared to the Lotus Valve System when used with the Lotus Introducer Set. Since the overall risk profile of the device has not changed, it can be concluded that the potential benefits of & Removed references specific to the 29 mm LOTUS Edge device since the text in these 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Table 4.16 shows rates of CEC-adjudicated VARCdefined events during the index procedure, through discharge/7 days, and to 30 days. In Cohort A, one subject experienced the majority of events and subsequently died on day 13 post implant. In Cohort B, events were minimal. In summary, acute and 30-day outcomes in the REPRISE NG DS study demonstrate acceptable performance and safety of the LOTUS Edge System. \\\\\nTable 4.1-5 and Table 4.1-6.\n\\end{tabular}","text_display":"\\begin{tabular}{l}\ncases of moderate or severe PVR at discharge or 30 days in either cohort. Table 4.16 shows rates of CEC-adjudicated VARCdefined events during the index procedure, through discharge/7 days, and to 30 days. In Cohort A, one subject experienced the majority of events and subsequently died on day 13 post implant. In Cohort B, events were minimal. In summary, acute and 30-day outcomes in the REPRISE NG DS study demonstrate acceptable performance and safety of the LOTUS Edge System. \\\\\nTable 4.1-5 and Table 4.1-6.\n\\end{tabular}","cell_row":1,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.98095703125,"confidence_rate":0.9999648391691596},{"cnt":[[517,499],[1346,499],[1346,540],[517,540]],"region":{"top_left_x":516,"top_left_y":498,"width":831,"height":42},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5c110059e8554f2bb7b697c6fe12ec02","type":"text","conversion_output":false,"parent_id":"587414f8ccd2448aabb671bdae40162e","text":"cases of moderate or severe PVR at discharge or 30 days in either","text_display":"cases of moderate or severe PVR at discharge or 30 days in either","confidence":0.99951171875,"confidence_rate":0.9999933096045984},{"cnt":[[517,538],[1275,538],[1275,574],[517,574]],"region":{"top_left_x":516,"top_left_y":537,"width":759,"height":38},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ff22bcc5eb1b4cf58ba7af3022bc9b85","type":"text","conversion_output":false,"parent_id":"587414f8ccd2448aabb671bdae40162e","text":"cohort. Table 4.16 shows rates of CEC-adjudicated VARC-","text_display":" cohort. Table 4.16 shows rates of CEC-adjudicated VARC","confidence":1,"confidence_rate":1},{"cnt":[[517,572],[1314,572],[1314,611],[517,611]],"region":{"top_left_x":516,"top_left_y":572,"width":798,"height":40},"line":31,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6b07a071fd37423bab7b131d2b2c9488","type":"text","conversion_output":false,"parent_id":"587414f8ccd2448aabb671bdae40162e","text":"defined events during the index procedure, through discharge/7","text_display":"defined events during the index procedure, through discharge/7","confidence":0.99951171875,"confidence_rate":0.9999927104668955},{"cnt":[[517,611],[1307,611],[1307,648],[517,648]],"region":{"top_left_x":516,"top_left_y":611,"width":792,"height":38},"line":32,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"195f572029b845f1b6b258f18a0cf82f","type":"text","conversion_output":false,"parent_id":"587414f8ccd2448aabb671bdae40162e","text":"days, and to 30 days. In Cohort A, one subject experienced the","text_display":" days, and to 30 days. In Cohort A, one subject experienced the","confidence":1,"confidence_rate":1},{"cnt":[[517,646],[1338,646],[1338,683],[517,683]],"region":{"top_left_x":516,"top_left_y":645,"width":822,"height":38},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a58e4f8c0419464881fccf81ceb51a09","type":"text","conversion_output":false,"parent_id":"587414f8ccd2448aabb671bdae40162e","text":"majority of events and subsequently died on day 13 post implant.","text_display":" majority of events and subsequently died on day 13 post implant.","confidence":1,"confidence_rate":1},{"cnt":[[517,681],[1342,681],[1342,719],[517,719]],"region":{"top_left_x":516,"top_left_y":680,"width":826,"height":40},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ef671e12269c4139950a44c6516bab70","type":"text","conversion_output":false,"parent_id":"587414f8ccd2448aabb671bdae40162e","text":"In Cohort B, events were minimal. In summary, acute and 30-day","text_display":" In Cohort B, events were minimal. In summary, acute and 30-day","confidence":0.98095703125,"confidence_rate":0.9997130766726946},{"cnt":[[517,717],[1329,717],[1329,756],[517,756]],"region":{"top_left_x":516,"top_left_y":717,"width":813,"height":40},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"bd87bbb9070c48e6a3c2ac74437abd7c","type":"text","conversion_output":false,"parent_id":"587414f8ccd2448aabb671bdae40162e","text":"outcomes in the REPRISE NG DS study demonstrate acceptable","text_display":" outcomes in the REPRISE NG DS study demonstrate acceptable","confidence":0.9990234375,"confidence_rate":0.9999844915544187},{"cnt":[[517,754],[1182,754],[1182,791],[517,791]],"region":{"top_left_x":516,"top_left_y":754,"width":666,"height":37},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4ee29c4c08cc441390c2b7328e774127","type":"text","conversion_output":false,"parent_id":"587414f8ccd2448aabb671bdae40162e","text":"performance and safety of the LOTUS Edge System.","text_display":" performance and safety of the LOTUS Edge System.","confidence":1,"confidence_rate":1},{"cnt":[[517,793],[891,793],[891,826],[517,826]],"region":{"top_left_x":516,"top_left_y":793,"width":376,"height":33},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"49f0fc9154a5491bbbefacbd36386085","type":"text","conversion_output":false,"parent_id":"587414f8ccd2448aabb671bdae40162e","text":"Table 4.1-5 and Table 4.1-6.","text_display":"\nTable 4.1-5 and Table 4.1-6.","confidence":1,"confidence_rate":1},{"cnt":[[1372,499],[2212,499],[2212,1659],[1372,1659]],"region":{"top_left_x":1372,"top_left_y":498,"width":841,"height":1162},"line":38,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"58346ae4d6c04ed2a4dfaac0d02b4253","type":"complex_cell","conversion_output":false,"parent_id":"635d8d3196d5483fbbc86479f2c5db6c","children_ids":["2f9267516aa3454d98c5c3b78a6ef225","d71e2c95dd404f73ad0247cebdc2b8d8","a19c9c179a5c4233b8513ce52863a326","3c98ea0b2416460cad4db6d7e9cd89a6","dac90a46fdcd44f591207572b3bf918b","6035f084f1e94d27956f3e547233037c","ab733cb7cf3d4c168c4d661e36cc85e3","b974c5f71f654d588ad49ec63499d6ca","d7957e0490794ca086ee80d88295d50c","e5775c0fb3db42c1ba5b1329fd788b90","6cb1b8c961eb4e5188b1a7d08b33dc86","ff4c1ba133944ac3a1801b3297b85b3e","415b7a96122342379934aa6489d658fb","8b48e4fd334e4b038902307961473ddd","c25187fcb92d437faa6e81f200c1b4b7","a710086c527b4cadb2778dcb4f3ee76e","65c2814d4183486bb75eb29f87a94ae2","390ec4bd8a184b9f8aa8b9d753bbe879","56c3632625564a28b7e105f612d3e79a","5ca4657670174a08ab9fc8cd0a106609","b4a3ad5d5ce24f4ea5f5aec5d5f563c3","01457491045d4f17b1a00e68812734d4","606cb632d29147cb918b9c03a5100a01","5240dea0470140c1b3a66f298dddf2e2","5e6bdfb3663e42469e512339e52d7cf9","390405558af54e178684369636521277","3a948d9607b54d67aac72e2c722c25f1","c3f479899ca54d39bbf62b0795eeff4c","229e7f93a06d4a3da05ab741d3dd0b88","e4d325d10d7b42a0ad8113661d73006d","8b1929fc1b7c40ac8793bcd27d097c9a"],"text":"\\begin{tabular}{l}\nyear. In Cohort A, one subject experienced the majority of events and subsequently died on day 13 post implant. Another subject died on day 119; the primary cause of death was multiorgan failure, which was not considered related to the index procedure. In Cohort B, events were minimal through 1 year post implant. To date, acute and 30-day outcomes were sustained through 1 year in both cohorts. Overall, the results in Cohorts A and B of the REPRISE NG DS study demonstrate acceptable performance and safety of the LOTUS Edge System. Added 1 year results in Table 4.1-5 and Table 4.1-6. \\\\\nUsing the latest iteration of the LOTUS Edge Valve System with either the Lotus or expandable iSleeve Introducer, the primary endpoint was achieved in 21/21 subjects in Cohort C, which resulted in improved valve performance and no moderate or severe PVR at discharge/7 days and 30 days post implant (Table 4.1-7) based on echocardiographic core lab analysis. A summary of clinical outcomes through discharge/7 days and 30 days is presented in Table 4.1-8. There was no mortality. Disabling stroke occurred on day 0 in one subject. Only \\(2 / 21\\) subjects (9.5\\%) were implanted with a new permanent pacemaker (PPM) through 30 days post implant, which is lower than previously observed in studies with the Lotus Valve System. This may be attributed to the design of the LOTUS Edge delivery system with its flexibility and ability to minimize the depth of the valve frame during deployment within the annulus, thereby reducing the potential for unnecessary interaction with the left ventricular outflow tract and the conduction system of the heart. These outcomes in the REPRISE NG DS Cohort C subjects demonstrate acceptable performance and safety of the LOTUS Edge System through 30 days post implant. \\\\\nAdded Table 4.1-7 and Table 4.1-8.\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nyear. In Cohort A, one subject experienced the majority of events and subsequently died on day 13 post implant. Another subject died on day 119; the primary cause of death was multiorgan failure, which was not considered related to the index procedure. In Cohort B, events were minimal through 1 year post implant. To date, acute and 30-day outcomes were sustained through 1 year in both cohorts. Overall, the results in Cohorts A and B of the REPRISE NG DS study demonstrate acceptable performance and safety of the LOTUS Edge System. Added 1 year results in Table 4.1-5 and Table 4.1-6. \\\\\nUsing the latest iteration of the LOTUS Edge Valve System with either the Lotus or expandable iSleeve Introducer, the primary endpoint was achieved in 21/21 subjects in Cohort C, which resulted in improved valve performance and no moderate or severe PVR at discharge/7 days and 30 days post implant (Table 4.1-7) based on echocardiographic core lab analysis. A summary of clinical outcomes through discharge/7 days and 30 days is presented in Table 4.1-8. There was no mortality. Disabling stroke occurred on day 0 in one subject. Only \\(2 / 21\\) subjects (9.5\\%) were implanted with a new permanent pacemaker (PPM) through 30 days post implant, which is lower than previously observed in studies with the Lotus Valve System. This may be attributed to the design of the LOTUS Edge delivery system with its flexibility and ability to minimize the depth of the valve frame during deployment within the annulus, thereby reducing the potential for unnecessary interaction with the left ventricular outflow tract and the conduction system of the heart. These outcomes in the REPRISE NG DS Cohort C subjects demonstrate acceptable performance and safety of the LOTUS Edge System through 30 days post implant. \\\\\nAdded Table 4.1-7 and Table 4.1-8.\n\\end{tabular}","cell_row":1,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":0.55029296875,"confidence_rate":0.999669122532365},{"cnt":[[1377,499],[2204,499],[2204,540],[1377,540]],"region":{"top_left_x":1376,"top_left_y":498,"width":828,"height":42},"line":39,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2f9267516aa3454d98c5c3b78a6ef225","type":"text","conversion_output":false,"parent_id":"58346ae4d6c04ed2a4dfaac0d02b4253","text":"year. In Cohort A, one subject experienced the majority of events","text_display":"year. In Cohort A, one subject experienced the majority of events","confidence":1,"confidence_rate":1},{"cnt":[[1379,538],[2176,538],[2176,574],[1379,574]],"region":{"top_left_x":1378,"top_left_y":537,"width":798,"height":38},"line":40,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d71e2c95dd404f73ad0247cebdc2b8d8","type":"text","conversion_output":false,"parent_id":"58346ae4d6c04ed2a4dfaac0d02b4253","text":"and subsequently died on day 13 post implant. Another subject","text_display":" and subsequently died on day 13 post implant. Another subject","confidence":1,"confidence_rate":1},{"cnt":[[1379,572],[2134,572],[2134,611],[1379,611]],"region":{"top_left_x":1378,"top_left_y":572,"width":757,"height":40},"line":41,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a19c9c179a5c4233b8513ce52863a326","type":"text","conversion_output":false,"parent_id":"58346ae4d6c04ed2a4dfaac0d02b4253","text":"died on day 119; the primary cause of death was multiorgan","text_display":" died on day 119; the primary cause of death was multiorgan","confidence":0.9990234375,"confidence_rate":0.9999844915544187},{"cnt":[[1379,609],[2195,609],[2195,648],[1379,648]],"region":{"top_left_x":1378,"top_left_y":609,"width":818,"height":40},"line":42,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3c98ea0b2416460cad4db6d7e9cd89a6","type":"text","conversion_output":false,"parent_id":"58346ae4d6c04ed2a4dfaac0d02b4253","text":"failure, which was not considered related to the index procedure.","text_display":" failure, which was not considered related to the index procedure.","confidence":1,"confidence_rate":1},{"cnt":[[1379,646],[2171,646],[2171,683],[1379,683]],"region":{"top_left_x":1378,"top_left_y":645,"width":794,"height":38},"line":43,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"dac90a46fdcd44f591207572b3bf918b","type":"text","conversion_output":false,"parent_id":"58346ae4d6c04ed2a4dfaac0d02b4253","text":"In Cohort B, events were minimal through 1 year post implant.","text_display":" In Cohort B, events were minimal through 1 year post implant.","confidence":1,"confidence_rate":1},{"cnt":[[1379,681],[2156,681],[2156,717],[1379,717]],"region":{"top_left_x":1378,"top_left_y":680,"width":779,"height":38},"line":44,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6035f084f1e94d27956f3e547233037c","type":"text","conversion_output":false,"parent_id":"58346ae4d6c04ed2a4dfaac0d02b4253","text":"To date, acute and 30-day outcomes were sustained through 1","text_display":" To date, acute and 30-day outcomes were sustained through 1","confidence":0.55029296875,"confidence_rate":0.990563779829879},{"cnt":[[1379,717],[2176,717],[2176,756],[1379,756]],"region":{"top_left_x":1378,"top_left_y":717,"width":798,"height":40},"line":45,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ab733cb7cf3d4c168c4d661e36cc85e3","type":"text","conversion_output":false,"parent_id":"58346ae4d6c04ed2a4dfaac0d02b4253","text":"year in both cohorts. Overall, the results in Cohorts A and B of","text_display":" year in both cohorts. Overall, the results in Cohorts A and B of","confidence":1,"confidence_rate":1},{"cnt":[[1379,754],[2199,754],[2199,791],[1379,791]],"region":{"top_left_x":1378,"top_left_y":754,"width":822,"height":37},"line":46,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b974c5f71f654d588ad49ec63499d6ca","type":"text","conversion_output":false,"parent_id":"58346ae4d6c04ed2a4dfaac0d02b4253","text":"the REPRISE NG DS study demonstrate acceptable performance","text_display":" the REPRISE NG DS study demonstrate acceptable performance","confidence":1,"confidence_rate":1},{"cnt":[[1379,789],[2186,789],[2186,826],[1379,826]],"region":{"top_left_x":1378,"top_left_y":788,"width":809,"height":38},"line":47,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d7957e0490794ca086ee80d88295d50c","type":"text","conversion_output":false,"parent_id":"58346ae4d6c04ed2a4dfaac0d02b4253","text":"and safety of the LOTUS Edge System. Added 1 year results in","text_display":" and safety of the LOTUS Edge System. Added 1 year results in","confidence":0.9990234375,"confidence_rate":0.9999856318731074},{"cnt":[[1379,826],[1753,826],[1753,860],[1379,860]],"region":{"top_left_x":1378,"top_left_y":825,"width":376,"height":36},"line":48,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e5775c0fb3db42c1ba5b1329fd788b90","type":"text","conversion_output":false,"parent_id":"58346ae4d6c04ed2a4dfaac0d02b4253","text":"Table 4.1-5 and Table 4.1-6.","text_display":" Table 4.1-5 and Table 4.1-6.","confidence":1,"confidence_rate":1},{"cnt":[[1379,901],[2195,901],[2195,938],[1379,938]],"region":{"top_left_x":1378,"top_left_y":901,"width":818,"height":38},"line":49,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6cb1b8c961eb4e5188b1a7d08b33dc86","type":"text","conversion_output":false,"parent_id":"58346ae4d6c04ed2a4dfaac0d02b4253","text":"Using the latest iteration of the LOTUS Edge Valve System with","text_display":"\nUsing the latest iteration of the LOTUS Edge Valve System with","confidence":1,"confidence_rate":1},{"cnt":[[1379,936],[2163,936],[2163,973],[1379,973]],"region":{"top_left_x":1378,"top_left_y":936,"width":785,"height":37},"line":50,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ff4c1ba133944ac3a1801b3297b85b3e","type":"text","conversion_output":false,"parent_id":"58346ae4d6c04ed2a4dfaac0d02b4253","text":"either the Lotus or expandable iSleeve Introducer, the primary","text_display":" either the Lotus or expandable iSleeve Introducer, the primary","confidence":1,"confidence_rate":1},{"cnt":[[1379,973],[2139,973],[2139,1012],[1379,1012]],"region":{"top_left_x":1378,"top_left_y":972,"width":761,"height":40},"line":51,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"415b7a96122342379934aa6489d658fb","type":"text","conversion_output":false,"parent_id":"58346ae4d6c04ed2a4dfaac0d02b4253","text":"endpoint was achieved in 21/21 subjects in Cohort C, which","text_display":" endpoint was achieved in 21/21 subjects in Cohort C, which","confidence":0.9931671619415283,"confidence_rate":0.9998911759411196},{"cnt":[[1379,1010],[2134,1010],[2134,1046],[1379,1046]],"region":{"top_left_x":1378,"top_left_y":1009,"width":757,"height":38},"line":52,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8b48e4fd334e4b038902307961473ddd","type":"text","conversion_output":false,"parent_id":"58346ae4d6c04ed2a4dfaac0d02b4253","text":"resulted in improved valve performance and no moderate or","text_display":" resulted in improved valve performance and no moderate or","confidence":1,"confidence_rate":1},{"cnt":[[1379,1044],[2191,1044],[2191,1081],[1379,1081]],"region":{"top_left_x":1378,"top_left_y":1044,"width":813,"height":38},"line":53,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c25187fcb92d437faa6e81f200c1b4b7","type":"text","conversion_output":false,"parent_id":"58346ae4d6c04ed2a4dfaac0d02b4253","text":"severe PVR at discharge/7 days and 30 days post implant (Table","text_display":" severe PVR at discharge/7 days and 30 days post implant (Table","confidence":0.97900390625,"confidence_rate":0.9996969081356405},{"cnt":[[1379,1081],[2195,1081],[2195,1120],[1379,1120]],"region":{"top_left_x":1378,"top_left_y":1081,"width":818,"height":40},"line":54,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a710086c527b4cadb2778dcb4f3ee76e","type":"text","conversion_output":false,"parent_id":"58346ae4d6c04ed2a4dfaac0d02b4253","text":"4.1-7) based on echocardiographic core lab analysis. A summary","text_display":" 4.1-7) based on echocardiographic core lab analysis. A summary","confidence":1,"confidence_rate":1},{"cnt":[[1379,1118],[2147,1118],[2147,1155],[1379,1155]],"region":{"top_left_x":1378,"top_left_y":1117,"width":770,"height":38},"line":55,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"65c2814d4183486bb75eb29f87a94ae2","type":"text","conversion_output":false,"parent_id":"58346ae4d6c04ed2a4dfaac0d02b4253","text":"of clinical outcomes through discharge/7 days and 30 days is","text_display":" of clinical outcomes through discharge/7 days and 30 days is","confidence":0.9951171875,"confidence_rate":0.9999280206439216},{"cnt":[[1379,1153],[2134,1153],[2134,1189],[1379,1189]],"region":{"top_left_x":1378,"top_left_y":1152,"width":757,"height":38},"line":56,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"390ec4bd8a184b9f8aa8b9d753bbe879","type":"text","conversion_output":false,"parent_id":"58346ae4d6c04ed2a4dfaac0d02b4253","text":"presented in Table 4.1-8. There was no mortality. Disabling","text_display":" presented in Table 4.1-8. There was no mortality. Disabling","confidence":1,"confidence_rate":1},{"cnt":[[1379,1187],[2126,1187],[2126,1224],[1379,1224]],"region":{"top_left_x":1378,"top_left_y":1187,"width":748,"height":38},"line":57,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"56c3632625564a28b7e105f612d3e79a","type":"text","conversion_output":false,"parent_id":"58346ae4d6c04ed2a4dfaac0d02b4253","text":"stroke occurred on day 0 in one subject. Only \\(2 / 21\\) subjects","text_display":" stroke occurred on day 0 in one subject. 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This may be","text_display":" observed in studies with the Lotus Valve System. 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Device Description & Test devices include the Lotus \\({ }^{\\text {TM }}\\) Valve System available in valve sizes of \\(21 mm, 23 mm, 25 mm\\), and 27 mm diameter, and the LOTUS Edge \\({ }^{\\text {TM }}\\) Valve System available in a valve size of 29 mm diameter (Section 5.1). & Test devices include the Lotus \\({ }^{\\text {TM }}\\) Valve System available in valve sizes of \\(21 mm, 23 mm, 25 mm\\), and 27 mm diameter, and the LOTUS Edge \\({ }^{\\text {TM }}\\) Valve System available in valve sizes of 23 mm , \\(25 mm, 27 mm\\), and of 29 mm diameter (Section 5.1). & Updated to include the LOTUS Edge Nested Registry (23 \\(mm , 25 mm, 27 mm\\) ) and device description \\\\\n\\hline 5.1 LOTUS Valve System Investigational Device (Test) & \\begin{tabular}{l}\n5.1 LOTUS Valve System and LOTUS Edge Valve System Investigational Devices (Test) \\\\\n...into the aortic vessel. Lotus Valve System device sizes used in the randomized cohort and the U.S. Continued Access Study cohort include \\(23 mm, 25 mm\\), and 27 mm diameter. Devices in the Lotus 21 mm Nested Registry cohort are 21 mm in diameter. The LOTUS Edge Valve System is a design iteration of the Lotus Valve System. Devices in the LOTUS Edge 29 mm Nested Registry cohort are 29 mm in diameter. More detailed product information is contained in the Investigator Brochure and Instructions For Use (IFU) for both devices. \\\\\n5.1.1 Lotus Valve and LOTUS Edge Valve \\\\\n...The Lotus Valve device is designed to produce a final diameter of \\(21 mm, 23 mm, 25 mm\\), or 27 mm (depending on valve size) when the valve is locked. In the deployed state, the frame height of the 21 mm valve is approximately 15 mm ; the frame height of the three larger valve sizes is approximately 19 mm . The valve component of the 29 mm LOTUS Edge device is scaled from the \\(23 mm, 25 mm\\), and 27 mm valve sizes. Additionally, the LOTUS Edge 29 mm valve has a pad sewn between the braid and buckle to prevent interaction between the two components during sheathing and unsheathing of the valve. The frame height of the 29 mm valve in the deployed state is 21 mm ... \\\\\n5.1.2 Lotus and LOTUS Edge Delivery System \\\\\n...Overall, the Delivery System for the LOTUS Edge Valve System is similar to that of the Lotus Valve System. Additionally, it has a modified leadscrew component, which\n\\end{tabular} & \\begin{tabular}{l}\n5.1 LOTUS Valve System and LOTUS Edge Valve System Investigational Devices (Test) \\\\\n...into the aortic vessel. Lotus Valve System device sizes used in the randomized cohort and the U.S. Continued Access Study cohort include \\(23 mm, 25 mm\\), and 27 mm diameter. Devices in the Lotus 21 mm Nested Registry cohort are 21 mm in diameter. The LOTUS Edge Valve System is a design iteration of the Lotus Valve System. LOTUS Edge device sizes used in the Nested Registries include \\(23 mm, 25 mm, 27 mm\\), and 29 mm roll-in and Nested Registry cohorts are 29 mm in diameter. More detailed product information is contained in the Investigator Brochure and Instructions For Use (IFU) for both devices. \\\\\n5.1.1 Lotus Valve and LOTUS Edge Valve \\\\\n...The Lotus Valve device is designed to produce a final diameter of \\(21 mm, 23 mm, 25 mm\\), or 27 mm (depending on valve size) when the valve is locked. In the deployed state, the frame height of the 21 mm valve is approximately 15 mm ; the frame height of the three larger valve sizes is approximately 19 mm . Similarly, the LOTUS Edge Valve is designed to produce a final diameter of \\(23 mm, 25 mm\\), or 27 mm (depending on valve size) when the valve is locked, with a frame height of approximately 19 mm for all three sizes. The valve component of the 29 mm LOTUS Edge device is scaled from the \\(23 mm, 25 mm\\), and 27 mm valve sizes. Additionally, the LOTUS Edge 29 mm valve has a pad sewn between the braid and buckle to prevent interaction between the two components during sheathing and unsheathing of the valve. The frame height of the 29 mm valve in the deployed state is 21\n\\end{tabular} & \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Table 27.1-9: Table of Changes for REPRISE III Protocol Version AJ (Compared to REPRISE III Protocol Version AI)}\n\\begin{tabular}{|l|l|l|l|}\n\\hline Section Modified & Text as Written in REPRISE III Protocol Version AI & Text as Written in REPRISE III Protocol Version AJ & Justification for Modification \\\\\n\\hline & can be concluded that the potential benefits of the use of the 29 mm LOTUS Edge Valve System with the Lotus Introducer Set out-weigh the risks. & the use of the LOTUS Edge Valve System with the Lotus Introducer Set out-weigh the risks. & sections now refers to all sizes of LOTUS Edge. \\\\\n\\hline 5. Device Description & Test devices include the Lotus \\({ }^{\\text {TM }}\\) Valve System available in valve sizes of \\(21 mm, 23 mm, 25 mm\\), and 27 mm diameter, and the LOTUS Edge \\({ }^{\\text {TM }}\\) Valve System available in a valve size of 29 mm diameter (Section 5.1). & Test devices include the Lotus \\({ }^{\\text {TM }}\\) Valve System available in valve sizes of \\(21 mm, 23 mm, 25 mm\\), and 27 mm diameter, and the LOTUS Edge \\({ }^{\\text {TM }}\\) Valve System available in valve sizes of 23 mm , \\(25 mm, 27 mm\\), and of 29 mm diameter (Section 5.1). & Updated to include the LOTUS Edge Nested Registry (23 \\(mm , 25 mm, 27 mm\\) ) and device description \\\\\n\\hline 5.1 LOTUS Valve System Investigational Device (Test) & \\begin{tabular}{l}\n5.1 LOTUS Valve System and LOTUS Edge Valve System Investigational Devices (Test) \\\\\n...into the aortic vessel. Lotus Valve System device sizes used in the randomized cohort and the U.S. Continued Access Study cohort include \\(23 mm, 25 mm\\), and 27 mm diameter. Devices in the Lotus 21 mm Nested Registry cohort are 21 mm in diameter. The LOTUS Edge Valve System is a design iteration of the Lotus Valve System. Devices in the LOTUS Edge 29 mm Nested Registry cohort are 29 mm in diameter. More detailed product information is contained in the Investigator Brochure and Instructions For Use (IFU) for both devices. \\\\\n5.1.1 Lotus Valve and LOTUS Edge Valve \\\\\n...The Lotus Valve device is designed to produce a final diameter of \\(21 mm, 23 mm, 25 mm\\), or 27 mm (depending on valve size) when the valve is locked. In the deployed state, the frame height of the 21 mm valve is approximately 15 mm ; the frame height of the three larger valve sizes is approximately 19 mm . The valve component of the 29 mm LOTUS Edge device is scaled from the \\(23 mm, 25 mm\\), and 27 mm valve sizes. Additionally, the LOTUS Edge 29 mm valve has a pad sewn between the braid and buckle to prevent interaction between the two components during sheathing and unsheathing of the valve. The frame height of the 29 mm valve in the deployed state is 21 mm ... \\\\\n5.1.2 Lotus and LOTUS Edge Delivery System \\\\\n...Overall, the Delivery System for the LOTUS Edge Valve System is similar to that of the Lotus Valve System. Additionally, it has a modified leadscrew component, which\n\\end{tabular} & \\begin{tabular}{l}\n5.1 LOTUS Valve System and LOTUS Edge Valve System Investigational Devices (Test) \\\\\n...into the aortic vessel. Lotus Valve System device sizes used in the randomized cohort and the U.S. Continued Access Study cohort include \\(23 mm, 25 mm\\), and 27 mm diameter. Devices in the Lotus 21 mm Nested Registry cohort are 21 mm in diameter. The LOTUS Edge Valve System is a design iteration of the Lotus Valve System. LOTUS Edge device sizes used in the Nested Registries include \\(23 mm, 25 mm, 27 mm\\), and 29 mm roll-in and Nested Registry cohorts are 29 mm in diameter. More detailed product information is contained in the Investigator Brochure and Instructions For Use (IFU) for both devices. \\\\\n5.1.1 Lotus Valve and LOTUS Edge Valve \\\\\n...The Lotus Valve device is designed to produce a final diameter of \\(21 mm, 23 mm, 25 mm\\), or 27 mm (depending on valve size) when the valve is locked. In the deployed state, the frame height of the 21 mm valve is approximately 15 mm ; the frame height of the three larger valve sizes is approximately 19 mm . Similarly, the LOTUS Edge Valve is designed to produce a final diameter of \\(23 mm, 25 mm\\), or 27 mm (depending on valve size) when the valve is locked, with a frame height of approximately 19 mm for all three sizes. The valve component of the 29 mm LOTUS Edge device is scaled from the \\(23 mm, 25 mm\\), and 27 mm valve sizes. Additionally, the LOTUS Edge 29 mm valve has a pad sewn between the braid and buckle to prevent interaction between the two components during sheathing and unsheathing of the valve. The frame height of the 29 mm valve in the deployed state is 21\n\\end{tabular} & 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LOTUS Valve System and LOTUS Edge Valve System Investigational Devices (Test) \\\\\n...into the aortic vessel. Lotus Valve System device sizes used in the randomized cohort and the U.S. Continued Access Study cohort include \\(23 mm, 25 mm\\), and 27 mm diameter. Devices in the Lotus 21 mm Nested Registry cohort are 21 mm in diameter. The LOTUS Edge Valve System is a design iteration of the Lotus Valve System. Devices in the LOTUS Edge 29 mm Nested Registry cohort are 29 mm in diameter. More detailed product information is contained in the Investigator Brochure and Instructions For Use (IFU) for both devices. \\\\\n5.1.1 Lotus Valve and LOTUS Edge Valve \\\\\n...The Lotus Valve device is designed to produce a final diameter of \\(21 mm, 23 mm, 25 mm\\), or 27 mm (depending on valve size) when the valve is locked. In the deployed state, the frame height of the 21 mm valve is approximately 15 mm ; the frame height of the three larger valve sizes is approximately 19 mm . The valve component of the 29 mm LOTUS Edge device is scaled from the \\(23 mm, 25 mm\\), and 27 mm valve sizes. Additionally, the LOTUS Edge 29 mm valve has a pad sewn between the braid and buckle to prevent interaction between the two components during sheathing and unsheathing of the valve. The frame height of the 29 mm valve in the deployed state is 21 mm ... \\\\\n5.1.2 Lotus and LOTUS Edge Delivery System \\\\\n...Overall, the Delivery System for the LOTUS Edge Valve System is similar to that of the Lotus Valve System. Additionally, it has a modified leadscrew component, which\n\\end{tabular}","text_display":"\\begin{tabular}{l}\n5.1 LOTUS Valve System and LOTUS Edge Valve System Investigational Devices (Test) \\\\\n...into the aortic vessel. Lotus Valve System device sizes used in the randomized cohort and the U.S. Continued Access Study cohort include \\(23 mm, 25 mm\\), and 27 mm diameter. Devices in the Lotus 21 mm Nested Registry cohort are 21 mm in diameter. The LOTUS Edge Valve System is a design iteration of the Lotus Valve System. 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Devices in","text_display":" cohort include \\(23 mm, 25 mm\\), and 27 mm diameter. Devices in","confidence":0.998046875,"confidence_rate":0.9999742761882866},{"cnt":[[517,966],[1329,966],[1329,1003],[517,1003]],"region":{"top_left_x":516,"top_left_y":966,"width":813,"height":38},"line":71,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f93c79556178481b925907b326d38555","type":"text","conversion_output":false,"parent_id":"0797d1501c074426baef8142769ff669","text":"the Lotus 21 mm Nested Registry cohort are 21 mm in diameter.","text_display":" the Lotus 21 mm Nested Registry cohort are 21 mm in diameter.","confidence":1,"confidence_rate":1},{"cnt":[[517,1001],[1344,1001],[1344,1042],[517,1042]],"region":{"top_left_x":516,"top_left_y":1001,"width":829,"height":42},"line":72,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8aad10cd7e5f4d46b217cfa2c548e218","type":"text","conversion_output":false,"parent_id":"0797d1501c074426baef8142769ff669","text":"The LOTUS Edge Valve System is a design iteration of the Lotus","text_display":" The LOTUS Edge Valve System is a design iteration of the Lotus","confidence":1,"confidence_rate":1},{"cnt":[[517,1040],[1264,1040],[1264,1077],[517,1077]],"region":{"top_left_x":516,"top_left_y":1039,"width":748,"height":38},"line":73,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ca237faa36a5427e91187145e9d2f6a4","type":"text","conversion_output":false,"parent_id":"0797d1501c074426baef8142769ff669","text":"Valve System. 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The frame height of the","text_display":" sheathing and unsheathing of the valve. The frame height of the","confidence":1,"confidence_rate":1},{"cnt":[[515,1599],[1106,1599],[1106,1635],[515,1635]],"region":{"top_left_x":514,"top_left_y":1598,"width":592,"height":38},"line":88,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9a66dee64412421fbfc6ec9cd4d560f3","type":"text","conversion_output":false,"parent_id":"0797d1501c074426baef8142769ff669","text":"29 mm valve in the deployed state is 21 mm ...","text_display":" 29 mm valve in the deployed state is 21 mm ...","confidence":0.6541457176208496,"confidence_rate":0.9925815980581935},{"cnt":[[515,1646],[1143,1646],[1143,1683],[515,1683]],"region":{"top_left_x":514,"top_left_y":1646,"width":629,"height":38},"line":89,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"cfd900fce15e4712a4e970306dc3ea29","type":"text","conversion_output":false,"parent_id":"0797d1501c074426baef8142769ff669","text":"5.1.2 Lotus and LOTUS Edge Delivery System","text_display":"\n5.1.2 Lotus and LOTUS Edge Delivery System","confidence":1,"confidence_rate":1},{"cnt":[[515,1690],[1273,1690],[1273,1729],[515,1729]],"region":{"top_left_x":514,"top_left_y":1689,"width":759,"height":40},"line":90,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4edc3de05f494e9bab840b85abeed7a6","type":"text","conversion_output":false,"parent_id":"0797d1501c074426baef8142769ff669","text":"...Overall, the Delivery System for the LOTUS Edge Valve","text_display":"\n...Overall, the Delivery System for the LOTUS Edge Valve","confidence":1,"confidence_rate":1},{"cnt":[[517,1726],[1173,1726],[1173,1765],[517,1765]],"region":{"top_left_x":516,"top_left_y":1726,"width":657,"height":40},"line":91,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b0e327c943f2486dbd5a719f0978c821","type":"text","conversion_output":false,"parent_id":"0797d1501c074426baef8142769ff669","text":"System is similar to that of the Lotus Valve System.","text_display":" System is similar to that of the Lotus Valve System.","confidence":0.83642578125,"confidence_rate":0.9968712645882418},{"cnt":[[517,1763],[1277,1763],[1277,1800],[517,1800]],"region":{"top_left_x":516,"top_left_y":1763,"width":761,"height":38},"line":92,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"31dab50b44e54b74956031318e45dc0f","type":"text","conversion_output":false,"parent_id":"0797d1501c074426baef8142769ff669","text":"Additionally, it has a modified leadscrew component, which","text_display":" Additionally, it has a modified leadscrew component, which","confidence":1,"confidence_rate":1},{"cnt":[[1374,776],[2212,776],[2212,1783],[1374,1783]],"region":{"top_left_x":1374,"top_left_y":775,"width":839,"height":1008},"line":93,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"99fdb1a02cd04fb7871e461cb4612d17","type":"complex_cell","conversion_output":false,"parent_id":"b5f7a96da96245c3b5f3123f87d367e2","children_ids":["d9de1b218e7b49b4a84c6089283e0821","50ce9b39b7bc44908c45c4430d28ecd8","f1f5cb4bd1c14f1492174a47d7343ffe","547dcec2c5d3498c8240cf3f4f378959","7aae6009488e43c79cd2ac888e2052c9","291ded6abeb94c1fbd3dcc3d538489ef","62769aeb26434e1fbb7cc70c587eca9b","6548148584a24468b0c62aa8299086d6","e098368d8e524c61a3837a68f0a109a1","470a670da8c8405a9b545801373d402d","676193c434c942eba5aad4d51d89eda9","597f645e3e2748549b9321d3818008d6","23704745d75142ca88e537da15e10e3b","c99f33ff7f5c411ab706423a91b6084b","1e84adddee324d1faabf772052908d55","8d6c8daecd214f21af6a2ecf2b2326d3","a6b4d5b31e3245ea8f89fa5278bf1f07","b4df5497db6a4a1dbb5e3c3275c74f74","605ff71f32134510b5998e0a276d9395","a96c5d8e4f9945a0995d66703a025597","f391ef2280d744b4af678c1d824ed814","ddd9d9a2fcd7440883ca6c33ae483543","9981bfde4da347f49ba37bbdd36214b2","26bb9846de254dcfb5b3db88750698a2","678d30619c4f476fb9efe37ab9706b6f","22cc16ebe6404d66983aa1219354e8bb","5835817cc16d4063a221df2ee6213179"],"text":"\\begin{tabular}{l}\n5.1 LOTUS Valve System and LOTUS Edge Valve System Investigational Devices (Test) \\\\\n...into the aortic vessel. Lotus Valve System device sizes used in the randomized cohort and the U.S. Continued Access Study cohort include \\(23 mm, 25 mm\\), and 27 mm diameter. Devices in the Lotus 21 mm Nested Registry cohort are 21 mm in diameter. The LOTUS Edge Valve System is a design iteration of the Lotus Valve System. LOTUS Edge device sizes used in the Nested Registries include \\(23 mm, 25 mm, 27 mm\\), and 29 mm roll-in and Nested Registry cohorts are 29 mm in diameter. More detailed product information is contained in the Investigator Brochure and Instructions For Use (IFU) for both devices. \\\\\n5.1.1 Lotus Valve and LOTUS Edge Valve \\\\\n...The Lotus Valve device is designed to produce a final diameter of \\(21 mm, 23 mm, 25 mm\\), or 27 mm (depending on valve size) when the valve is locked. In the deployed state, the frame height of the 21 mm valve is approximately 15 mm ; the frame height of the three larger valve sizes is approximately 19 mm . Similarly, the LOTUS Edge Valve is designed to produce a final diameter of \\(23 mm, 25 mm\\), or 27 mm (depending on valve size) when the valve is locked, with a frame height of approximately 19 mm for all three sizes. The valve component of the 29 mm LOTUS Edge device is scaled from the \\(23 mm, 25 mm\\), and 27 mm valve sizes. Additionally, the LOTUS Edge 29 mm valve has a pad sewn between the braid and buckle to prevent interaction between the two components during sheathing and unsheathing of the valve. The frame height of the 29 mm valve in the deployed state is 21\n\\end{tabular}","text_display":"\\begin{tabular}{l}\n5.1 LOTUS Valve System and LOTUS Edge Valve System Investigational Devices (Test) \\\\\n...into the aortic vessel. Lotus Valve System device sizes used in the randomized cohort and the U.S. Continued Access Study cohort include \\(23 mm, 25 mm\\), and 27 mm diameter. Devices in the Lotus 21 mm Nested Registry cohort are 21 mm in diameter. The LOTUS Edge Valve System is a design iteration of the Lotus Valve System. LOTUS Edge device sizes used in the Nested Registries include \\(23 mm, 25 mm, 27 mm\\), and 29 mm roll-in and Nested Registry cohorts are 29 mm in diameter. More detailed product information is contained in the Investigator Brochure and Instructions For Use (IFU) for both devices. \\\\\n5.1.1 Lotus Valve and LOTUS Edge Valve \\\\\n...The Lotus Valve device is designed to produce a final diameter of \\(21 mm, 23 mm, 25 mm\\), or 27 mm (depending on valve size) when the valve is locked. In the deployed state, the frame height of the 21 mm valve is approximately 15 mm ; the frame height of the three larger valve sizes is approximately 19 mm . Similarly, the LOTUS Edge Valve is designed to produce a final diameter of \\(23 mm, 25 mm\\), or 27 mm (depending on valve size) when the valve is locked, with a frame height of approximately 19 mm for all three sizes. The valve component of the 29 mm LOTUS Edge device is scaled from the \\(23 mm, 25 mm\\), and 27 mm valve sizes. Additionally, the LOTUS Edge 29 mm valve has a pad sewn between the braid and buckle to prevent interaction between the two components during sheathing and unsheathing of the valve. The frame height of the 29 mm valve in the deployed state is 21\n\\end{tabular}","cell_row":3,"cell_column":2,"cell_row_span":1,"cell_col_span":1,"confidence":0.9985356330871582,"confidence_rate":0.9999985276236176},{"cnt":[[1379,776],[2160,776],[2160,817],[1379,817]],"region":{"top_left_x":1378,"top_left_y":775,"width":783,"height":42},"line":94,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d9de1b218e7b49b4a84c6089283e0821","type":"text","conversion_output":false,"parent_id":"99fdb1a02cd04fb7871e461cb4612d17","text":"5.1 LOTUS Valve System and LOTUS Edge Valve System","text_display":"5.1 LOTUS Valve System and LOTUS Edge Valve System","confidence":1,"confidence_rate":1},{"cnt":[[1379,815],[1775,815],[1775,852],[1379,852]],"region":{"top_left_x":1378,"top_left_y":814,"width":398,"height":38},"line":95,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"50ce9b39b7bc44908c45c4430d28ecd8","type":"text","conversion_output":false,"parent_id":"99fdb1a02cd04fb7871e461cb4612d17","text":"Investigational Devices (Test)","text_display":" Investigational Devices (Test)","confidence":1,"confidence_rate":1},{"cnt":[[1379,858],[2199,858],[2199,895],[1379,895]],"region":{"top_left_x":1378,"top_left_y":858,"width":822,"height":37},"line":96,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f1f5cb4bd1c14f1492174a47d7343ffe","type":"text","conversion_output":false,"parent_id":"99fdb1a02cd04fb7871e461cb4612d17","text":"...into the aortic vessel. Lotus Valve System device sizes used in","text_display":"\n...into the aortic vessel. Lotus Valve System device sizes used in","confidence":0.9985356330871582,"confidence_rate":0.9999793602109479},{"cnt":[[1379,895],[2143,895],[2143,932],[1379,932]],"region":{"top_left_x":1378,"top_left_y":894,"width":766,"height":38},"line":97,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"547dcec2c5d3498c8240cf3f4f378959","type":"text","conversion_output":false,"parent_id":"99fdb1a02cd04fb7871e461cb4612d17","text":"the randomized cohort and the U.S. Continued Access Study","text_display":" the randomized cohort and the U.S. Continued Access Study","confidence":1,"confidence_rate":1},{"cnt":[[1379,932],[2186,932],[2186,966],[1379,966]],"region":{"top_left_x":1378,"top_left_y":931,"width":809,"height":36},"line":98,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7aae6009488e43c79cd2ac888e2052c9","type":"text","conversion_output":false,"parent_id":"99fdb1a02cd04fb7871e461cb4612d17","text":"cohort include \\(23 mm, 25 mm\\), and 27 mm diameter. Devices in","text_display":" cohort include \\(23 mm, 25 mm\\), and 27 mm diameter. Devices in","confidence":0.99951171875,"confidence_rate":0.9999935736983052},{"cnt":[[1379,966],[2191,966],[2191,1003],[1379,1003]],"region":{"top_left_x":1378,"top_left_y":966,"width":813,"height":38},"line":99,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"291ded6abeb94c1fbd3dcc3d538489ef","type":"text","conversion_output":false,"parent_id":"99fdb1a02cd04fb7871e461cb4612d17","text":"the Lotus 21 mm Nested Registry cohort are 21 mm in diameter.","text_display":" the Lotus 21 mm Nested Registry cohort are 21 mm in diameter.","confidence":0.99951171875,"confidence_rate":0.9999935736983052},{"cnt":[[1379,1001],[2208,1001],[2208,1040],[1379,1040]],"region":{"top_left_x":1378,"top_left_y":1001,"width":831,"height":39},"line":100,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"62769aeb26434e1fbb7cc70c587eca9b","type":"text","conversion_output":false,"parent_id":"99fdb1a02cd04fb7871e461cb4612d17","text":"The LOTUS Edge Valve System is a design iteration of the Lotus","text_display":" The LOTUS Edge Valve System is a design iteration of the Lotus","confidence":1,"confidence_rate":1},{"cnt":[[1379,1040],[2143,1040],[2143,1077],[1379,1077]],"region":{"top_left_x":1378,"top_left_y":1039,"width":766,"height":38},"line":101,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6548148584a24468b0c62aa8299086d6","type":"text","conversion_output":false,"parent_id":"99fdb1a02cd04fb7871e461cb4612d17","text":"Valve System. LOTUS Edge device sizes used in the Nested","text_display":" Valve System. LOTUS Edge device sizes used in the Nested","confidence":1,"confidence_rate":1},{"cnt":[[1379,1075],[2208,1075],[2208,1111],[1379,1111]],"region":{"top_left_x":1378,"top_left_y":1074,"width":831,"height":38},"line":102,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e098368d8e524c61a3837a68f0a109a1","type":"text","conversion_output":false,"parent_id":"99fdb1a02cd04fb7871e461cb4612d17","text":"Registries include \\(23 mm, 25 mm, 27 mm\\), and 29 mm roll-in and","text_display":" Registries include \\(23 mm, 25 mm, 27 mm\\), and 29 mm roll-in and","confidence":1,"confidence_rate":1},{"cnt":[[1379,1109],[2169,1109],[2169,1148],[1379,1148]],"region":{"top_left_x":1378,"top_left_y":1109,"width":792,"height":40},"line":103,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"470a670da8c8405a9b545801373d402d","type":"text","conversion_output":false,"parent_id":"99fdb1a02cd04fb7871e461cb4612d17","text":"Nested Registry cohorts are 29 mm in diameter. More detailed","text_display":" Nested Registry cohorts are 29 mm in diameter. More detailed","confidence":1,"confidence_rate":1},{"cnt":[[1379,1148],[2206,1148],[2206,1185],[1379,1185]],"region":{"top_left_x":1378,"top_left_y":1148,"width":828,"height":38},"line":104,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"676193c434c942eba5aad4d51d89eda9","type":"text","conversion_output":false,"parent_id":"99fdb1a02cd04fb7871e461cb4612d17","text":"product information is contained in the Investigator Brochure and","text_display":" product information is contained in the Investigator Brochure and","confidence":1,"confidence_rate":1},{"cnt":[[1379,1183],[1935,1183],[1935,1220],[1379,1220]],"region":{"top_left_x":1378,"top_left_y":1182,"width":558,"height":38},"line":105,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"597f645e3e2748549b9321d3818008d6","type":"text","conversion_output":false,"parent_id":"99fdb1a02cd04fb7871e461cb4612d17","text":"Instructions For Use (IFU) for both devices.","text_display":" Instructions For Use (IFU) for both devices.","confidence":1,"confidence_rate":1},{"cnt":[[1379,1231],[1948,1231],[1948,1267],[1379,1267]],"region":{"top_left_x":1378,"top_left_y":1230,"width":571,"height":38},"line":106,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"23704745d75142ca88e537da15e10e3b","type":"text","conversion_output":false,"parent_id":"99fdb1a02cd04fb7871e461cb4612d17","text":"5.1.1 Lotus Valve and LOTUS Edge Valve","text_display":"\n5.1.1 Lotus Valve and LOTUS Edge Valve","confidence":1,"confidence_rate":1},{"cnt":[[1379,1276],[2208,1276],[2208,1311],[1379,1311]],"region":{"top_left_x":1378,"top_left_y":1276,"width":831,"height":35},"line":107,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c99f33ff7f5c411ab706423a91b6084b","type":"text","conversion_output":false,"parent_id":"99fdb1a02cd04fb7871e461cb4612d17","text":"...The Lotus Valve device is designed to produce a final diameter","text_display":"\n...The Lotus Valve device is designed to produce a final diameter","confidence":1,"confidence_rate":1},{"cnt":[[1379,1313],[2180,1313],[2180,1347],[1379,1347]],"region":{"top_left_x":1378,"top_left_y":1312,"width":802,"height":36},"line":108,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1e84adddee324d1faabf772052908d55","type":"text","conversion_output":false,"parent_id":"99fdb1a02cd04fb7871e461cb4612d17","text":"of \\(21 mm, 23 mm, 25 mm\\), or 27 mm (depending on valve size)","text_display":" of \\(21 mm, 23 mm, 25 mm\\), or 27 mm (depending on valve size)","confidence":1,"confidence_rate":1},{"cnt":[[1379,1347],[2191,1347],[2191,1384],[1379,1384]],"region":{"top_left_x":1378,"top_left_y":1347,"width":813,"height":38},"line":109,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8d6c8daecd214f21af6a2ecf2b2326d3","type":"text","conversion_output":false,"parent_id":"99fdb1a02cd04fb7871e461cb4612d17","text":"when the valve is locked. In the deployed state, the frame height","text_display":" when the valve is locked. In the deployed state, the frame height","confidence":1,"confidence_rate":1},{"cnt":[[1379,1382],[2191,1382],[2191,1419],[1379,1419]],"region":{"top_left_x":1378,"top_left_y":1382,"width":813,"height":37},"line":110,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a6b4d5b31e3245ea8f89fa5278bf1f07","type":"text","conversion_output":false,"parent_id":"99fdb1a02cd04fb7871e461cb4612d17","text":"of the 21 mm valve is approximately 15 mm ; the frame height of","text_display":" of the 21 mm valve is approximately 15 mm ; the frame height of","confidence":0.99951171875,"confidence_rate":0.9999937384747559},{"cnt":[[1379,1417],[2169,1417],[2169,1458],[1379,1458]],"region":{"top_left_x":1378,"top_left_y":1416,"width":792,"height":42},"line":111,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b4df5497db6a4a1dbb5e3c3275c74f74","type":"text","conversion_output":false,"parent_id":"99fdb1a02cd04fb7871e461cb4612d17","text":"the three larger valve sizes is approximately 19 mm . Similarly,","text_display":" the three larger valve sizes is approximately 19 mm . Similarly,","confidence":1,"confidence_rate":1},{"cnt":[[1379,1456],[2178,1456],[2178,1493],[1379,1493]],"region":{"top_left_x":1378,"top_left_y":1455,"width":800,"height":38},"line":112,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"605ff71f32134510b5998e0a276d9395","type":"text","conversion_output":false,"parent_id":"99fdb1a02cd04fb7871e461cb4612d17","text":"the LOTUS Edge Valve is designed to produce a final diameter","text_display":" the LOTUS Edge Valve is designed to produce a final diameter","confidence":1,"confidence_rate":1},{"cnt":[[1379,1490],[2197,1490],[2197,1527],[1379,1527]],"region":{"top_left_x":1378,"top_left_y":1490,"width":820,"height":38},"line":113,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a96c5d8e4f9945a0995d66703a025597","type":"text","conversion_output":false,"parent_id":"99fdb1a02cd04fb7871e461cb4612d17","text":"of \\(23 mm, 25 mm\\), or 27 mm (depending on valve size) when the","text_display":" of \\(23 mm, 25 mm\\), or 27 mm (depending on valve size) when the","confidence":1,"confidence_rate":1},{"cnt":[[1379,1527],[2195,1527],[2195,1566],[1379,1566]],"region":{"top_left_x":1378,"top_left_y":1527,"width":818,"height":40},"line":114,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f391ef2280d744b4af678c1d824ed814","type":"text","conversion_output":false,"parent_id":"99fdb1a02cd04fb7871e461cb4612d17","text":"valve is locked, with a frame height of approximately 19 mm for","text_display":" valve is locked, with a frame height of approximately 19 mm for","confidence":1,"confidence_rate":1},{"cnt":[[1379,1564],[2197,1564],[2197,1601],[1379,1601]],"region":{"top_left_x":1378,"top_left_y":1564,"width":820,"height":37},"line":115,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ddd9d9a2fcd7440883ca6c33ae483543","type":"text","conversion_output":false,"parent_id":"99fdb1a02cd04fb7871e461cb4612d17","text":"all three sizes. The valve component of the 29 mm LOTUS Edge","text_display":" all three sizes. The valve component of the 29 mm LOTUS Edge","confidence":1,"confidence_rate":1},{"cnt":[[1379,1599],[2199,1599],[2199,1635],[1379,1635]],"region":{"top_left_x":1378,"top_left_y":1598,"width":822,"height":38},"line":116,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"9981bfde4da347f49ba37bbdd36214b2","type":"text","conversion_output":false,"parent_id":"99fdb1a02cd04fb7871e461cb4612d17","text":"device is scaled from the \\(23 mm, 25 mm\\), and 27 mm valve sizes.","text_display":" device is scaled from the \\(23 mm, 25 mm\\), and 27 mm valve sizes.","confidence":1,"confidence_rate":1},{"cnt":[[1379,1633],[2143,1633],[2143,1672],[1379,1672]],"region":{"top_left_x":1378,"top_left_y":1633,"width":766,"height":40},"line":117,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"26bb9846de254dcfb5b3db88750698a2","type":"text","conversion_output":false,"parent_id":"99fdb1a02cd04fb7871e461cb4612d17","text":"Additionally, the LOTUS Edge 29 mm valve has a pad sewn","text_display":" Additionally, the LOTUS Edge 29 mm valve has a pad sewn","confidence":1,"confidence_rate":1},{"cnt":[[1379,1672],[2186,1672],[2186,1709],[1379,1709]],"region":{"top_left_x":1378,"top_left_y":1672,"width":809,"height":38},"line":118,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"678d30619c4f476fb9efe37ab9706b6f","type":"text","conversion_output":false,"parent_id":"99fdb1a02cd04fb7871e461cb4612d17","text":"between the braid and buckle to prevent interaction between the","text_display":" between the braid and buckle to prevent interaction between the","confidence":1,"confidence_rate":1},{"cnt":[[1379,1707],[2182,1707],[2182,1744],[1379,1744]],"region":{"top_left_x":1378,"top_left_y":1706,"width":805,"height":38},"line":119,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"22cc16ebe6404d66983aa1219354e8bb","type":"text","conversion_output":false,"parent_id":"99fdb1a02cd04fb7871e461cb4612d17","text":"two components during sheathing and unsheathing of the valve.","text_display":" two components during sheathing and unsheathing of the valve.","confidence":1,"confidence_rate":1},{"cnt":[[1379,1742],[2182,1742],[2182,1778],[1379,1778]],"region":{"top_left_x":1378,"top_left_y":1741,"width":805,"height":38},"line":120,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5835817cc16d4063a221df2ee6213179","type":"text","conversion_output":false,"parent_id":"99fdb1a02cd04fb7871e461cb4612d17","text":"The frame height of the 29 mm valve in the deployed state is 21","text_display":" The frame height of the 29 mm valve in the deployed state is 21","confidence":1,"confidence_rate":1},{"cnt":[[103,2024],[312,2024],[312,2065],[103,2065]],"region":{"top_left_x":103,"top_left_y":2023,"width":209,"height":42},"line":121,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"942d1cf3420f42b0b97f83c400aecc15","type":"page_info","conversion_output":false,"text":"Released","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1143,2028],[1605,2028],[1605,2065],[1143,2065]],"region":{"top_left_x":1142,"top_left_y":2028,"width":463,"height":37},"line":122,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7971de0408df474e975eee5929635b02","type":"page_info","conversion_output":false,"text":"REPRISE III Protocol","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[2279,2024],[2606,2024],[2606,2065],[2279,2065]],"region":{"top_left_x":2279,"top_left_y":2023,"width":328,"height":42},"line":123,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f3de6ff82e4642d09ed7f9d854463551","type":"page_info","conversion_output":false,"text":"90899936 AK. 4","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[799,2067],[1983,2067],[1983,2108],[799,2108]],"region":{"top_left_x":799,"top_left_y":2066,"width":1185,"height":42},"line":124,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8d2908061ba84019b587816c4b2c8fd8","type":"page_info","conversion_output":false,"text":"Boston Scientific Confidential. Unauthorized use is prohibited.","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[2247,2062],[2628,2062],[2628,2108],[2247,2108]],"region":{"top_left_x":2247,"top_left_y":2062,"width":381,"height":46},"line":125,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d272c678c35b470a872dae82fc01429a","type":"page_info","conversion_output":false,"text":"Page 183 of 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AI)","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[245,400],[2542,400],[2542,1807],[245,1807]],"region":{"top_left_x":244,"top_left_y":399,"width":2298,"height":1408},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"efb24eda502b4006b0a9a22fb07fc4f8","type":"table","conversion_output":true,"children_ids":["1b8c0ffa1959412fad9664dbd62dd226","c22634929deb464f854b69e3bc4ad1a2","278cfefc2d3e4696b082cfc12ce4333c","38b575aefd0e49a09a80ae0f6d99637a","02e9fbe5ae3f46c583a8cba0dbe03e07","2483e00118244e4aaa274cfaf8ce39d7","40d18af08ea043cdbf78e0a41addd824","f22e7c7c2244432c96640ca822271d2c","fa2779e1be8a40c89b40aca0687352f2","91ef4bac31714857b441019af317177e","cc04067aa0dd4ae5895a12f228d72065","faf152158175471293e08fcf4d937cb2","ba5042e4b5cd44fdbeda8ec0b5956a29","e36b2619bc5c4ef2b2304babc8c48261","eb7168f96d7d4800854509e5c0bf8c29","6c2cdd0464204c1e8a3e4b6b385da473","a3fc94218f4e4d49a765352fa0aeab9c","4b860ca87a7f460095997b9d7665f01b","decf976c8ed04d499ba28ebf7fe2a3e6","48c27b49d786401d974291726edc24b6","c7a99d0b9c7a443e97b30a497a51f202","c6538e731f0f4e6794caf3d2eee05ad8","7b6d6da374a3490fa579973e1a558dff","ae11e52bdf04461a9dd3fcf69a1d0fb0","46f450def52842df94b35fa4a8f432f2","a2e23e3226a540faa3d4242f43a38139","cc68acd28abd4a2db8d5fc37f196b468","b9adb99848994017b81c018649bcc888","95db4bab83e54e5dbdcb5fac861cf291","414b117537174bdeac196945194487e8","ae78e892b033461eb6133324c2dfa7db","b014882b9e314a88ae0eaf80fe862622","9dee5e6ca31a4bc5a59e709f98d26596","f2eebef4e5cd48878349d734acaaa6d8"],"selected_labels":["67e6ec47d00b4ea1afbb5c38957927b0"],"text":"\\begin{tabular}{|l|l|l|l|}\n\\hline Section Modified & Text as Written in REPRISE III Protocol Version AI & Text as Written in REPRISE III Protocol Version AJ & Justification for Modification \\\\\n\\hline & results in a slightly decreased rate of retraction of the outer sheath during valve deployment compared to the Lotus Valve System. The multi-lumen catheter and outer sheath components of LOTUS Edge have been modified to enhance deliverability. & \\begin{tabular}{l}\nmm... \\\\\n5.1.2 Lotus and LOTUS Edge Delivery System \\\\\n...Overall, the Delivery System for the LOTUS Edge Valve System is similar to that of the Lotus Valve System. \\\\\nAdditionally, it has a modified leadscrew component, referred to as the Depthguard \\({ }^{\\text {TM }}\\) technology, which results in a slightly decreased rate of retraction of the outer sheath during valve deployment compared to the Lotus Valve System. The multilumen catheter and outer sheath components of LOTUS Edge have been modified to enhance deliverability.\n\\end{tabular} & \\\\\n\\hline 5.3 Device Labeling & \\begin{tabular}{l}\n5.3.1 Test Device \\\\\n... \\\\\n- Expiration (use by) date (labeled as month/year, device not to be used after the last day of the indicated month)\n\\end{tabular} & \\begin{tabular}{l}\n5.3.1 Test Device \\\\\n... \\\\\n- Expiration (use by) date\n\\end{tabular} & Updated to clarify \\\\\n\\hline 6. Objectives & The objective of the REPRISE III trial is to evaluate the safety and effectiveness of the Lotus \\({ }^{\\text {TM }}\\) Valve System and LOTUS Edge \\({ }^{\\text {TM }}\\) Valve System ( 29 mm valve) for transcatheter... & The objective of the REPRISE III trial is to evaluate the safety and effectiveness of the Lotus \\({ }^{\\text {TM }}\\) Valve System and LOTUS Edge \\({ }^{\\text {TM }}\\) Valve System for transcatheter... & \\multirow[t]{4}{*}{\\begin{tabular}{l}\nUpdated to include the LOTUS Edge \\\\\nNested Registry (23 \\(mm , 25 mm, 27 mm\\) )\n\\end{tabular}} \\\\\n\\hline 7. Endpoints & Among the roll-in, (initial cohort with \\(23 mm, 25 mm\\), and 27 mm Lotus Valve System and subsequent cohort with 29 mm LOTUS Edge Valve System), Lotus 21 mm Nested Registry, LOTUS Edge 29 mm Nested Registry, and U.S. Continued Access Study cohorts, for ITT analyses... & Among the roll-in, (initial cohort with \\(23 mm, 25 mm\\), and 27 mm Lotus Valve System and subsequent cohort with 29 mm LOTUS Edge Valve System), Lotus 21 mm Nested Registry, LOTUS Edge Nested Registry, LOTUS Edge 29 mm Nested Registry, and U.S. Continued Access Study cohorts, for ITT analyses... & \\\\\n\\hline 8.1 Scale and Duration & ...There will also be a non-randomized, roll-in phase with the 29 mm LOTUS Edge Valve for centers that do not have prior experience implanting the LOTUS Edge Valve System, and a nested registry cohort of subjects who will receive the 29 mm LOTUS Edge Valve System (LOTUS Edge 29 mm Nested Registry). Participating centers will be centers that have enrolled subjects in REPRISE III with the Lotus Valve System. & An additional single-arm, non-randomized, nested registry cohort of subjects who will receive the \\(23 mm, 25 mm\\), or 27 mm LOTUS Edge Valve System (LOTUS Edge Nested Registry) will be conducted to confirm performance of the Lotus Valve implantation procedure with the Edge delivery system. There will also be a non-randomized, roll-in phase with the 29 mm LOTUS Edge Valve for centers that do not have prior experience implanting the LOTUS Edge Valve System, and a nested registry cohort of subjects who will receive the 29 mm LOTUS Edge Valve System (LOTUS Edge 29 mm Nested Registry). & \\\\\n\\hline 8.2 Treatment & Note: ...to further assess performance and safety. There will also & Note: ...to further assess performance and safety. Additionally, & \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Table 27.1-9: Table of Changes for REPRISE III Protocol Version AJ (Compared to REPRISE III Protocol Version AI)}\n\\begin{tabular}{|l|l|l|l|}\n\\hline Section Modified & Text as Written in REPRISE III Protocol Version AI & Text as Written in REPRISE III Protocol Version AJ & Justification for Modification \\\\\n\\hline & results in a slightly decreased rate of retraction of the outer sheath during valve deployment compared to the Lotus Valve System. The multi-lumen catheter and outer sheath components of LOTUS Edge have been modified to enhance deliverability. & \\begin{tabular}{l}\nmm... \\\\\n5.1.2 Lotus and LOTUS Edge Delivery System \\\\\n...Overall, the Delivery System for the LOTUS Edge Valve System is similar to that of the Lotus Valve System. \\\\\nAdditionally, it has a modified leadscrew component, referred to as the Depthguard \\({ }^{\\text {TM }}\\) technology, which results in a slightly decreased rate of retraction of the outer sheath during valve deployment compared to the Lotus Valve System. The multilumen catheter and outer sheath components of LOTUS Edge have been modified to enhance deliverability.\n\\end{tabular} & \\\\\n\\hline 5.3 Device Labeling & \\begin{tabular}{l}\n5.3.1 Test Device \\\\\n... \\\\\n- Expiration (use by) date (labeled as month/year, device not to be used after the last day of the indicated month)\n\\end{tabular} & \\begin{tabular}{l}\n5.3.1 Test Device \\\\\n... \\\\\n- Expiration (use by) date\n\\end{tabular} & Updated to clarify \\\\\n\\hline 6. Objectives & The objective of the REPRISE III trial is to evaluate the safety and effectiveness of the Lotus \\({ }^{\\text {TM }}\\) Valve System and LOTUS Edge \\({ }^{\\text {TM }}\\) Valve System ( 29 mm valve) for transcatheter... & The objective of the REPRISE III trial is to evaluate the safety and effectiveness of the Lotus \\({ }^{\\text {TM }}\\) Valve System and LOTUS Edge \\({ }^{\\text {TM }}\\) Valve System for transcatheter... & \\multirow[t]{4}{*}{\\begin{tabular}{l}\nUpdated to include the LOTUS Edge \\\\\nNested Registry (23 \\(mm , 25 mm, 27 mm\\) )\n\\end{tabular}} \\\\\n\\hline 7. Endpoints & Among the roll-in, (initial cohort with \\(23 mm, 25 mm\\), and 27 mm Lotus Valve System and subsequent cohort with 29 mm LOTUS Edge Valve System), Lotus 21 mm Nested Registry, LOTUS Edge 29 mm Nested Registry, and U.S. Continued Access Study cohorts, for ITT analyses... & Among the roll-in, (initial cohort with \\(23 mm, 25 mm\\), and 27 mm Lotus Valve System and subsequent cohort with 29 mm LOTUS Edge Valve System), Lotus 21 mm Nested Registry, LOTUS Edge Nested Registry, LOTUS Edge 29 mm Nested Registry, and U.S. Continued Access Study cohorts, for ITT analyses... & \\\\\n\\hline 8.1 Scale and Duration & ...There will also be a non-randomized, roll-in phase with the 29 mm LOTUS Edge Valve for centers that do not have prior experience implanting the LOTUS Edge Valve System, and a nested registry cohort of subjects who will receive the 29 mm LOTUS Edge Valve System (LOTUS Edge 29 mm Nested Registry). Participating centers will be centers that have enrolled subjects in REPRISE III with the Lotus Valve System. & An additional single-arm, non-randomized, nested registry cohort of subjects who will receive the \\(23 mm, 25 mm\\), or 27 mm LOTUS Edge Valve System (LOTUS Edge Nested Registry) will be conducted to confirm performance of the Lotus Valve implantation procedure with the Edge delivery system. There will also be a non-randomized, roll-in phase with the 29 mm LOTUS Edge Valve for centers that do not have prior experience implanting the LOTUS Edge Valve System, and a nested registry cohort of subjects who will receive the 29 mm LOTUS Edge Valve System (LOTUS Edge 29 mm Nested Registry). & \\\\\n\\hline 8.2 Treatment & Note: ...to further assess performance and safety. There will also & Note: ...to further assess performance and safety. 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Section Modified & Text as Written in REPRISE III Protocol Version AI & Text as Written in REPRISE III Protocol Version AJ & Justification for Modification \\\\\n\\hline Assignment & be a non-randomized, roll-in phase with the 29 mm LOTUS Edge Valve for centers that do not have previous experience implanting the LOTUS Edge Valve System (at least 2 roll-in cases/center), and a nested registry cohort of subjects who will receive the 29 mm LOTUS Edge Valve System (LOTUS Edge 29 mm Nested Registry). & subjects will be enrolled in a non-randomized, nested registry cohort with the \\(23 mm, 25 mm\\) or 27 mm LOTUS Edge Valve (LOTUS Edge Nested Registry) to confirm performance of the Lotus Valve implantation procedure with the Edge delivery system. There will also be a non-randomized, roll-in phase with the 29 mm LOTUS Edge Valve for centers that do not have previous experience implanting the LOTUS Edge Valve System (at least 2 roll-in cases/center), and a nested registry cohort of subjects who will receive the 29 mm LOTUS Edge Valve System (LOTUS Edge 29 mm Nested Registry). & \\multirow{5}{*}{} \\\\\n\\hline 8.3 Study Design Justification & There will be up to 2092 subjects in REPRISE III. In order... Registry, up to 1000 subjects will be enrolled in the U.S. Continued Access Study cohort, up to 20 subjects will be enrolled in the roll-in cohort with the 29 mm LOTUS Edge Valve, and up to 20 subjects will be enrolled in the LOTUS Edge 29 mm Nested Registry... & There will be up to 2142 subjects in REPRISE III. In order to support the stated objectives of this study (see Section 6) while also limiting the potential exposure of study subjects to risk, up to 120 subjects will be enrolled in the roll-in phase of this study (at centers without previous Lotus Valve experience), 912 subjects will be randomized and enrolled, up to 20 subjects will be enrolled in the Lotus 21 mm Nested Registry, up to 1000 subjects will be enrolled in the U.S. Continued Access Study cohort, at least 50 subjects will be enrolled in the LOTUS Edge Nested Registry, up to 20 subjects will be enrolled in the roll-in cohort with the 29 mm LOTUS Edge Valve, and up to 20 subjects will be enrolled in the LOTUS Edge 29 mm Nested Registry... & \\\\\n\\hline 10.1.5 LOTUS Edge \\(23-27 mm\\) Nested Registry Subjects & & For the LOTUS Edge \\(23-27 mm\\) Nested Registry, subjects confirmed eligible for the study by the CRC (see Section 22.2) and who provided written informed consent are considered enrolled in the study as soon as an attempt is made to insert the LOTUS Edge Valve System into the subject's femoral artery. & \\\\\n\\hline Figure 11.1-1 & & Updated figure to include LOTUS Edge Nested Registry & \\\\\n\\hline 12.1 Endpoints & Data will be summarized separately from subjects in the roll-in (up to 120 subjects with the \\(23 mm, 25 mm\\) or 27 mm Lotus Valve), randomized, Lotus 21 mm Nested Registry, roll-in with the 29 mm LOTUS Edge Valve (up to 16 subjects), LOTUS Edge 29 mm Nested Registry, and U.S. Continued Access Study populations. Descriptive statistics will be used to summarize the & Data will be summarized separately from subjects in the roll-in (up to 120 subjects with the \\(23 mm, 25 mm\\) or 27 mm Lotus Valve), randomized, Lotus 21 mm Nested Registry, LOTUS Edge Nested Registry, roll-in with the 29 mm LOTUS Edge Valve (up to 20 subjects), LOTUS Edge 29 mm Nested Registry, and U.S. Continued Access Study populations. 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In order to support the stated objectives of this study (see Section 6) while also limiting the potential exposure of study subjects to risk, up to 120 subjects will be enrolled in the roll-in phase of this study (at centers without previous Lotus Valve experience), 912 subjects will be randomized and enrolled, up to 20 subjects will be enrolled in the Lotus 21 mm Nested Registry, up to 1000 subjects will be enrolled in the U.S. Continued Access Study cohort, at least 50 subjects will be enrolled in the LOTUS Edge Nested Registry, up to 20 subjects will be enrolled in the roll-in cohort with the 29 mm LOTUS Edge Valve, and up to 20 subjects will be enrolled in the LOTUS Edge 29 mm Nested Registry... & \\\\\n\\hline 10.1.5 LOTUS Edge \\(23-27 mm\\) Nested Registry Subjects & & For the LOTUS Edge \\(23-27 mm\\) Nested Registry, subjects confirmed eligible for the study by the CRC (see Section 22.2) and who provided written informed consent are considered enrolled in the study as soon as an attempt is made to insert the LOTUS Edge Valve System into the subject's femoral artery. & \\\\\n\\hline Figure 11.1-1 & & Updated figure to include LOTUS Edge Nested Registry & \\\\\n\\hline 12.1 Endpoints & Data will be summarized separately from subjects in the roll-in (up to 120 subjects with the \\(23 mm, 25 mm\\) or 27 mm Lotus Valve), randomized, Lotus 21 mm Nested Registry, roll-in with the 29 mm LOTUS Edge Valve (up to 16 subjects), LOTUS Edge 29 mm Nested Registry, and U.S. Continued Access Study populations. Descriptive statistics will be used to summarize the & Data will be summarized separately from subjects in the roll-in (up to 120 subjects with the \\(23 mm, 25 mm\\) or 27 mm Lotus Valve), randomized, Lotus 21 mm Nested Registry, LOTUS Edge Nested Registry, roll-in with the 29 mm LOTUS Edge Valve (up to 20 subjects), LOTUS Edge 29 mm Nested Registry, and U.S. Continued Access Study populations. 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Section Modified & Text as Written in REPRISE III Protocol Version AI & Text as Written in REPRISE III Protocol Version AJ & Justification for Modification \\\\\n\\hline & data from subjects in the roll-in, Lotus 21 mm Nested Registry, roll-in with the 29 mm LOTUS Edge, LOTUS Edge 29 mm Nested Registry, and U.S. Continued Study cohorts and no statistical inference will be made. & statistics will be used to summarize the data from subjects in the roll-in, Lotus 21 mm Nested Registry, LOTUS Edge Nested Registry, roll-in with the 29 mm LOTUS Edge, LOTUS Edge 29 mm Nested Registry, and U.S. Continued Access Study cohorts and no statistical inference will be made. & \\multirow{6}{*}{} \\\\\n\\hline 12.1.4 Baseline Comparability & \\begin{tabular}{l}\nBaseline data will be summarized by treatment group for the randomized subjects and separately for subjects in the roll-in, Lotus 21 mm Nested Registry, roll-in with the 29 mm LOTUS Edge Valve, LOTUS Edge 29 mm Nested Registry, and... \\\\\nNo formal statistical testing will be done for the roll-in (with the \\(23 mm, 25 mm\\), or 27 mm Lotus Valve), Lotus 21 mm Nested Registry, roll-in with the 29 mm LOTUS Edge Valve, LOTUS Edge 29 mm Nested Registry, or U.S. Continued Access Study subjects.\n\\end{tabular} & \\begin{tabular}{l}\nBaseline data will be summarized by treatment group for the randomized subjects and separately for subjects in the roll-in (with the \\(23 mm, 25 mm\\), or 27 mm Lotus Valve), Lotus 21 mm Nested Registry, LOTUS Edge Nested Registry, roll-in with the 29 mm LOTUS Edge Valve, LOTUS Edge 29 mm Nested Registry, and ... \\\\\nNo formal statistical testing will be done for the roll-in (with the \\(23 mm, 25 mm\\), or 27 mm Lotus Valve), Lotus 21 mm Nested Registry, LOTUS Edge Nested Registry, roll-in with the 29 mm LOTUS Edge Valve, LOTUS Edge 29 mm Nested Registry, or U.S. Continued Access Study subjects.\n\\end{tabular} & \\\\\n\\hline 12.1.5 Postprocedure Measurements & No formal statistical testing will be done for the roll-in (with the \\(23 mm, 25 mm\\), or 27 mm Lotus Valve), Lotus 21 mm Nested Registry, roll-in with the 29 mm LOTUS Edge Valve, LOTUS Edge 29 mm Nested Registry, or… & No formal statistical testing will be done for the roll-in (with the \\(23 mm, 25 mm\\), or 27 mm Lotus Valve), Lotus 21 mm Nested Registry, LOTUS Edge Nested Registry, roll-in with the 29 mm LOTUS Edge Valve, LOTUS Edge 29 mm Nested Registry, or... & \\\\\n\\hline 12.2.1 Analysis Sets & ... Among the roll-in (with the \\(23 mm, 25 mm\\), or 27 mm Lotus Valve), Lotus 21 mm Nested Registry, roll-in with the 29 mm LOTUS Edge Valve, LOTUS Edge 29 mm Nested Registry, and U.S. Continued Access Study cohorts, for ITT analyses... For these cohorts, the as-treated population includes all subjects implanted with the Lotus Valve. The as-treated and implanted analysis sets are the same for these cohorts. & ... Among the roll-in (with the \\(23 mm, 25 mm\\), or 27 mm Lotus Valve), Lotus 21 mm Nested Registry, LOTUS Edge Nested Registry, roll-in with the 29 mm LOTUS Edge Valve, LOTUS Edge 29 mm Nested Registry, and U.S. Continued Access Study cohorts, for ITT analyses... For these cohorts, the as-treated population includes all subjects implanted with the Lotus Valve. The as-treated and implanted analysis sets are the same for these cohorts. & \\\\\n\\hline 12.2.4 Reporting Events & For all subjects in the roll-in, (with the \\(23 mm, 25 mm\\), or 27 mm Lotus Valve), Lotus 21 mm Nested Registry, roll-in with the 29 mm LOTUS Edge Valve, LOTUS Edge 29 mm Nested Registry, and... & For all subjects in the roll-in, (with the \\(23 mm, 25 mm\\), or 27 mm Lotus Valve), Lotus 21 mm Nested Registry, LOTUS Edge Nested Registry, roll-in with the 29 mm LOTUS Edge Valve, LOTUS Edge 29 mm Nested Registry, and.... & \\\\\n\\hline 12.3.2 Interim & There will be an administrative analysis of 30-day data from & Administrative analyses of outcomes from the LOTUS Edge & \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Table 27.1-9: Table of Changes for REPRISE III Protocol Version AJ (Compared to REPRISE III Protocol Version AI)}\n\\begin{tabular}{|l|l|l|l|}\n\\hline Section Modified & Text as Written in REPRISE III Protocol Version AI & Text as Written in REPRISE III Protocol Version AJ & Justification for Modification \\\\\n\\hline & data from subjects in the roll-in, Lotus 21 mm Nested Registry, roll-in with the 29 mm LOTUS Edge, LOTUS Edge 29 mm Nested Registry, and U.S. Continued Study cohorts and no statistical inference will be made. & statistics will be used to summarize the data from subjects in the roll-in, Lotus 21 mm Nested Registry, LOTUS Edge Nested Registry, roll-in with the 29 mm LOTUS Edge, LOTUS Edge 29 mm Nested Registry, and U.S. Continued Access Study cohorts and no statistical inference will be made. & \\multirow{6}{*}{} \\\\\n\\hline 12.1.4 Baseline Comparability & \\begin{tabular}{l}\nBaseline data will be summarized by treatment group for the randomized subjects and separately for subjects in the roll-in, Lotus 21 mm Nested Registry, roll-in with the 29 mm LOTUS Edge Valve, LOTUS Edge 29 mm Nested Registry, and... \\\\\nNo formal statistical testing will be done for the roll-in (with the \\(23 mm, 25 mm\\), or 27 mm Lotus Valve), Lotus 21 mm Nested Registry, roll-in with the 29 mm LOTUS Edge Valve, LOTUS Edge 29 mm Nested Registry, or U.S. Continued Access Study subjects.\n\\end{tabular} & \\begin{tabular}{l}\nBaseline data will be summarized by treatment group for the randomized subjects and separately for subjects in the roll-in (with the \\(23 mm, 25 mm\\), or 27 mm Lotus Valve), Lotus 21 mm Nested Registry, LOTUS Edge Nested Registry, roll-in with the 29 mm LOTUS Edge Valve, LOTUS Edge 29 mm Nested Registry, and ... \\\\\nNo formal statistical testing will be done for the roll-in (with the \\(23 mm, 25 mm\\), or 27 mm Lotus Valve), Lotus 21 mm Nested Registry, LOTUS Edge Nested Registry, roll-in with the 29 mm LOTUS Edge Valve, LOTUS Edge 29 mm Nested Registry, or U.S. Continued Access Study subjects.\n\\end{tabular} & \\\\\n\\hline 12.1.5 Postprocedure Measurements & No formal statistical testing will be done for the roll-in (with the \\(23 mm, 25 mm\\), or 27 mm Lotus Valve), Lotus 21 mm Nested Registry, roll-in with the 29 mm LOTUS Edge Valve, LOTUS Edge 29 mm Nested Registry, or… & No formal statistical testing will be done for the roll-in (with the \\(23 mm, 25 mm\\), or 27 mm Lotus Valve), Lotus 21 mm Nested Registry, LOTUS Edge Nested Registry, roll-in with the 29 mm LOTUS Edge Valve, LOTUS Edge 29 mm Nested Registry, or... & \\\\\n\\hline 12.2.1 Analysis Sets & ... Among the roll-in (with the \\(23 mm, 25 mm\\), or 27 mm Lotus Valve), Lotus 21 mm Nested Registry, roll-in with the 29 mm LOTUS Edge Valve, LOTUS Edge 29 mm Nested Registry, and U.S. Continued Access Study cohorts, for ITT analyses... For these cohorts, the as-treated population includes all subjects implanted with the Lotus Valve. The as-treated and implanted analysis sets are the same for these cohorts. & ... Among the roll-in (with the \\(23 mm, 25 mm\\), or 27 mm Lotus Valve), Lotus 21 mm Nested Registry, LOTUS Edge Nested Registry, roll-in with the 29 mm LOTUS Edge Valve, LOTUS Edge 29 mm Nested Registry, and U.S. Continued Access Study cohorts, for ITT analyses... For these cohorts, the as-treated population includes all subjects implanted with the Lotus Valve. The as-treated and implanted analysis sets are the same for these cohorts. & \\\\\n\\hline 12.2.4 Reporting Events & For all subjects in the roll-in, (with the \\(23 mm, 25 mm\\), or 27 mm Lotus Valve), Lotus 21 mm Nested Registry, roll-in with the 29 mm LOTUS Edge Valve, LOTUS Edge 29 mm Nested Registry, and... & For all subjects in the roll-in, (with the \\(23 mm, 25 mm\\), or 27 mm Lotus Valve), Lotus 21 mm Nested Registry, LOTUS Edge Nested Registry, roll-in with the 29 mm LOTUS Edge Valve, LOTUS Edge 29 mm Nested Registry, and.... & \\\\\n\\hline 12.3.2 Interim & There will be an administrative analysis of 30-day data from & Administrative analyses of outcomes from the LOTUS Edge & 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This analysis will be performed for regulatory agency review on the first 30 implanted subjects from the combined cohort and will be carried out after these pooled subjects have completed their 30 day follow-up visits. & \\begin{tabular}{l}\nValve System (LOTUS Edge Nested Registry) will be performed for regulatory agency review after subjects have completed their implant procedure. \\\\\nThere will be an administrative analysis of 30-day data from implanted subjects receiving the LOTUS Edge 29 mm valve in the REPRISE III and the similarly designed REPRISE Edge 29 mm EU study. This analysis will be performed for regulatory agency review on the first 30 implanted subjects from the combined cohort and will be carried out after these pooled subjects have completed their 30 day follow-up visits.\n\\end{tabular} & \\multirow{3}{*}{} \\\\\n\\hline 17.4.1 Training with the Lotus Valve System/ LOTUS Edge Valve System & \\begin{tabular}{l}\nThe Sponsor is responsible for providing Investigators with the information and training on the Lotus Valve System they need... \\\\\nNote 2: Device training specific to the use of the 29 mm LOTUS Edge Valve System will be provided to investigators at participating centers prior to enrollment in the 29 mm roll-in cohort and LOTUS Edge 29 mm Nested Registry. For the participating investigators who have had sufficient experience implanting the Lotus Valve but not with the LOTUS Edge Valve System, additional training will be provided focused on the changes between Lotus and LOTUS Edge. For these Lotusexperienced investigators, at least 2 roll-in cases with the 29 mm LOTUS Edge Valve System will be performed before enrollment can commence in the LOTUS Edge 29 mm Nested Registry.\n\\end{tabular} & \\begin{tabular}{l}\nThe Sponsor is responsible for providing Investigators with the information and training on the Lotus Valve System/LOTUS Edge Valve System they need... \\\\\nNote 2: Device training specific to the use of the LOTUS Edge Valve System will be provided to investigators at participating centers prior to enrollment in the LOTUS Edge Nested Registry, 29 mm roll-in cohort and LOTUS Edge 29 mm Nested Registry. For the participating investigators who have had sufficient experience implanting the Lotus Valve but not with the LOTUS Edge Valve System, additional training will be provided focused on the changes between Lotus and LOTUS Edge. For Lotusexperienced investigators, at least 2 roll-in cases with the 29 mm LOTUS Edge Valve System will be performed before enrollment can commence in the LOTUS Edge 29 mm Nested Registry.\n\\end{tabular} & \\\\\n\\hline 19.4 Risk to Benefit Rationale & ...which has been associated with long term mortality in TAVR. No new hazards/harms are introduced by the 29 mm LOTUS Edge Valve System compared to the 21, 23, 25 and 27 mm Lotus Valve System when used with the Lotus Introducer Set. Since and the overall risk profile of the device has not changed, it can be concluded that the potential benefits of the use of the 29 mm LOTUS Edge Valve System with the Lotus Introducer Set outweigh the risks. & ...which has been associated with long term mortality in TAVR. No new hazards/harms are introduced by the LOTUS Edge Valve System compared to the Lotus Valve System when used with the Lotus Introducer Set. Since and the overall risk profile of the device has not changed, it can be concluded that the potential benefits of the use of the LOTUS Edge Valve System with the Lotus Introducer Set out-weigh the risks. & \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Table 27.1-9: Table of Changes for REPRISE III Protocol Version AJ (Compared to REPRISE III Protocol Version AI)}\n\\begin{tabular}{|l|l|l|l|}\n\\hline Section Modified & Text as Written in REPRISE III Protocol Version AI & Text as Written in REPRISE III Protocol Version AJ & Justification for Modification \\\\\n\\hline Analyses & implanted subjects receiving the LOTUS Edge 29 mm valve in the REPRISE III and the similarly designed REPRISE Edge 29 mm EU study. This analysis will be performed for regulatory agency review on the first 30 implanted subjects from the combined cohort and will be carried out after these pooled subjects have completed their 30 day follow-up visits. & \\begin{tabular}{l}\nValve System (LOTUS Edge Nested Registry) will be performed for regulatory agency review after subjects have completed their implant procedure. \\\\\nThere will be an administrative analysis of 30-day data from implanted subjects receiving the LOTUS Edge 29 mm valve in the REPRISE III and the similarly designed REPRISE Edge 29 mm EU study. 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