{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,6]],"date-time":"2026-11-06T05:41:08Z","timestamp":1793943668998,"version":"4.8.0"},"reference-count":103,"publisher":"Oxford University Press (OUP)","issue":"29","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Eur Heart J"],"published-print":{"date-parts":[[2015,8,1]]},"DOI":"10.1093\/eurheartj\/ehv281","type":"journal-article","created":{"date-parts":[[2015,7,13]],"date-time":"2015-07-13T22:40:09Z","timestamp":1436827209000},"page":"1851-1877","source":"Crossref","is-referenced-by-count":47,"title":["Clinical trial design principles and endpoint definitions for transcatheter mitral valve repair and replacement: part 1: clinical trial design principles"],"prefix":"10.1093","volume":"36","author":[{"given":"Gregg W.","family":"Stone","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alec S.","family":"Vahanian","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David H.","family":"Adams","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"William T.","family":"Abraham","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeffrey S.","family":"Borer","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeroen J.","family":"Bax","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joachim","family":"Schofer","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Donald E.","family":"Cutlip","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mitchell W.","family":"Krucoff","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eugene H.","family":"Blackstone","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Philippe","family":"G\u00e9n\u00e9reux","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael J.","family":"Mack","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert J.","family":"Siegel","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paul A.","family":"Grayburn","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maurice","family":"Enriquez-Sarano","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Patrizio","family":"Lancellotti","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gerasimos","family":"Filippatos","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Arie Pieter","family":"Kappetein","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2015,7,13]]},"reference":[{"key":"2015080316492479000_36.29.1851.1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2014.02.536"},{"key":"2015080316492479000_36.29.1851.2","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/ehs109"},{"key":"2015080316492479000_36.29.1851.3","doi-asserted-by":"publisher","DOI":"10.1016\/S0195-668X(03)00201-X"},{"key":"2015080316492479000_36.29.1851.4","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(06)69208-8"},{"key":"2015080316492479000_36.29.1851.5","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2011.06.032"},{"key":"2015080316492479000_36.29.1851.6","doi-asserted-by":"publisher","DOI":"10.1093\/ehjci\/jet191"},{"key":"2015080316492479000_36.29.1851.7","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(09)60692-9"},{"key":"2015080316492479000_36.29.1851.8","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1009355"},{"key":"2015080316492479000_36.29.1851.9","doi-asserted-by":"publisher","DOI":"10.1016\/j.echo.2011.07.003"},{"key":"2015080316492479000_36.29.1851.10","doi-asserted-by":"publisher","DOI":"10.1016\/j.jtcvs.2014.04.040"},{"key":"2015080316492479000_36.29.1851.11","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/ehq051"},{"key":"2015080316492479000_36.29.1851.12","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2013.03.060"},{"key":"2015080316492479000_36.29.1851.13","doi-asserted-by":"publisher","DOI":"10.1016\/j.athoracsur.2012.05.105"},{"key":"2015080316492479000_36.29.1851.14","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcin.2011.03.008"},{"key":"2015080316492479000_36.29.1851.15","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.106.685313"},{"key":"2015080316492479000_36.29.1851.16","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2010.12.005"},{"key":"2015080316492479000_36.29.1851.17","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2012.09.001"},{"key":"2015080316492479000_36.29.1851.18","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.110.009449"},{"key":"2015080316492479000_36.29.1851.19","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2012.02.022"},{"key":"2015080316492479000_36.29.1851.20","unstructured":"Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health Guidance for industry and Food and Drug Administration staff. Factors to consider when making benefit-risk determinations in medical device premarket approval and de novo classifications. March 28, 2012. Available at: http:\/\/www.fda.gov\/downloads\/medicaldevices\/deviceregulationandguidance\/guidancedocuments\/ucm296379.pdf . Accessed June 8, 2015."},{"key":"2015080316492479000_36.29.1851.21","doi-asserted-by":"publisher","DOI":"10.1016\/S1010-7940(99)00134-7"},{"key":"2015080316492479000_36.29.1851.22","doi-asserted-by":"publisher","DOI":"10.1093\/ejcts\/ezs043"},{"key":"2015080316492479000_36.29.1851.23","doi-asserted-by":"publisher","DOI":"10.1016\/j.athoracsur.2009.05.056"},{"key":"2015080316492479000_36.29.1851.24","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2005.06.079"},{"key":"2015080316492479000_36.29.1851.25","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.107.727271"},{"key":"2015080316492479000_36.29.1851.26","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1402670"},{"key":"2015080316492479000_36.29.1851.27","doi-asserted-by":"publisher","DOI":"10.1007\/s11886-008-0038-9"},{"key":"2015080316492479000_36.29.1851.28","doi-asserted-by":"publisher","DOI":"10.1053\/j.semtcvs.2007.04.002"},{"key":"2015080316492479000_36.29.1851.29","doi-asserted-by":"publisher","DOI":"10.1093\/ejechocard\/jeq031"},{"key":"2015080316492479000_36.29.1851.30","doi-asserted-by":"crossref","unstructured":"Carpentier A . Cardiac valve surgery-the \u201cFrench correction.\u201d J Thorac Cardiovasc Surg 1983;86:323\u2013337.","DOI":"10.1016\/S0022-5223(19)39144-5"},{"key":"2015080316492479000_36.29.1851.31","doi-asserted-by":"publisher","DOI":"10.1093\/ejcts\/ezr040"},{"key":"2015080316492479000_36.29.1851.32","doi-asserted-by":"publisher","DOI":"10.1136\/hrt.2007.134833"},{"key":"2015080316492479000_36.29.1851.33","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcmg.2012.02.005"},{"key":"2015080316492479000_36.29.1851.34","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1312808"},{"key":"2015080316492479000_36.29.1851.35","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2011.08.067"},{"key":"2015080316492479000_36.29.1851.36","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2013.12.062"},{"key":"2015080316492479000_36.29.1851.37","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/ehq411"},{"key":"2015080316492479000_36.29.1851.38","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCIMAGING.114.000992"},{"key":"2015080316492479000_36.29.1851.39","doi-asserted-by":"publisher","DOI":"10.1016\/S0894-7317(03)00335-3"},{"key":"2015080316492479000_36.29.1851.40","doi-asserted-by":"publisher","DOI":"10.1093\/ejechocard\/jeq121"},{"key":"2015080316492479000_36.29.1851.41","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCIMAGING.112.980383"},{"key":"2015080316492479000_36.29.1851.42","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.112.121590"},{"key":"2015080316492479000_36.29.1851.43","doi-asserted-by":"publisher","DOI":"10.1161\/01.CIR.103.13.1759"},{"key":"2015080316492479000_36.29.1851.44","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2014.10.016"},{"key":"2015080316492479000_36.29.1851.45","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCIMAGING.113.000474"},{"key":"2015080316492479000_36.29.1851.46","doi-asserted-by":"publisher","DOI":"10.1016\/j.euje.2006.11.002"},{"key":"2015080316492479000_36.29.1851.47","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa040532"},{"key":"2015080316492479000_36.29.1851.48","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/ehi189"},{"key":"2015080316492479000_36.29.1851.49","doi-asserted-by":"publisher","DOI":"10.1093\/ehjci\/jet060"},{"key":"2015080316492479000_36.29.1851.50","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2013.05.019"},{"key":"2015080316492479000_36.29.1851.51","doi-asserted-by":"publisher","DOI":"10.1067\/mje.2002.121534"},{"key":"2015080316492479000_36.29.1851.52","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/ehq222"},{"key":"2015080316492479000_36.29.1851.53","doi-asserted-by":"crossref","unstructured":"Maslow A . Mitral valve repair: an echocardio-graphic review: part 1. J Cardiothorac Vasc Anesth 2014;29:156\u2013177.","DOI":"10.1053\/j.jvca.2014.03.007"},{"key":"2015080316492479000_36.29.1851.54","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2010.11.043"},{"key":"2015080316492479000_36.29.1851.55","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2014.08.049"},{"key":"2015080316492479000_36.29.1851.56","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/5.suppl_D.73"},{"key":"2015080316492479000_36.29.1851.57","unstructured":"Jindani A Neville EM Venn G Para-prosthetic leak: a complication of cardiac valve replacement. J Cardiovasc Surg (Torino) 1991;32:503\u2013508."},{"key":"2015080316492479000_36.29.1851.58","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCIMAGING.110.947176"},{"key":"2015080316492479000_36.29.1851.59","doi-asserted-by":"publisher","DOI":"10.1016\/j.athoracsur.2010.06.116"},{"key":"2015080316492479000_36.29.1851.60","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/eht411"},{"key":"2015080316492479000_36.29.1851.61","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcmg.2008.12.025"},{"key":"2015080316492479000_36.29.1851.62","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.106.677880"},{"key":"2015080316492479000_36.29.1851.63","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcmg.2009.07.006"},{"key":"2015080316492479000_36.29.1851.64","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.110.009803"},{"key":"2015080316492479000_36.29.1851.65","doi-asserted-by":"publisher","DOI":"10.1161\/01.CIR.0000065226.24159.E9"},{"key":"2015080316492479000_36.29.1851.66","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.108.818724"},{"key":"2015080316492479000_36.29.1851.67","doi-asserted-by":"publisher","DOI":"10.1016\/S0735-1097(02)02937-6"},{"key":"2015080316492479000_36.29.1851.68","doi-asserted-by":"publisher","DOI":"10.1161\/hc2601.091704"},{"key":"2015080316492479000_36.29.1851.69","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejcts.2005.10.010"},{"key":"2015080316492479000_36.29.1851.70","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2014.02.556"},{"key":"2015080316492479000_36.29.1851.71","doi-asserted-by":"publisher","DOI":"10.1016\/j.athoracsur.2014.05.011"},{"key":"2015080316492479000_36.29.1851.72","doi-asserted-by":"publisher","DOI":"10.1016\/j.athoracsur.2013.06.051"},{"key":"2015080316492479000_36.29.1851.73","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/eht059"},{"key":"2015080316492479000_36.29.1851.74","doi-asserted-by":"publisher","DOI":"10.1093\/gerona\/56.3.M146"},{"key":"2015080316492479000_36.29.1851.75","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2010.06.039"},{"key":"2015080316492479000_36.29.1851.76","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcin.2012.06.011"},{"key":"2015080316492479000_36.29.1851.77","doi-asserted-by":"publisher","DOI":"10.1016\/j.amjcard.2013.04.046"},{"key":"2015080316492479000_36.29.1851.78","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2013.09.070"},{"key":"2015080316492479000_36.29.1851.79","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM199503023320902"},{"key":"2015080316492479000_36.29.1851.80","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.43.11.2412-a"},{"key":"2015080316492479000_36.29.1851.81","doi-asserted-by":"publisher","DOI":"10.1164\/ajrccm.166.1.at1102"},{"key":"2015080316492479000_36.29.1851.82","doi-asserted-by":"publisher","DOI":"10.1016\/S0735-1097(02)02164-2"},{"key":"2015080316492479000_36.29.1851.83","doi-asserted-by":"publisher","DOI":"10.1016\/0002-8703(92)90986-6"},{"key":"2015080316492479000_36.29.1851.84","doi-asserted-by":"crossref","unstructured":"McHorney CA Ware JE Jr. Raczek AE . The MOS 36-Item Short-Form Health Survey (SF-36): II. Psychometric and clinical tests of validity in measuring physical and mental health constructs. Med Care 1993;31:247\u2013263.","DOI":"10.1097\/00005650-199303000-00006"},{"key":"2015080316492479000_36.29.1851.85","doi-asserted-by":"publisher","DOI":"10.1097\/00005650-199603000-00003"},{"key":"2015080316492479000_36.29.1851.86","doi-asserted-by":"publisher","DOI":"10.1097\/00005650-200503000-00003"},{"key":"2015080316492479000_36.29.1851.87","doi-asserted-by":"publisher","DOI":"10.1016\/j.ahj.2004.12.010"},{"key":"2015080316492479000_36.29.1851.88","doi-asserted-by":"publisher","DOI":"10.1001\/jama.282.8.790"},{"key":"2015080316492479000_36.29.1851.89","doi-asserted-by":"crossref","unstructured":"Dragalin V . Adaptive designs: terminology and classification. Drug Inf J 2006;40:425\u2013435.","DOI":"10.1177\/216847900604000408"},{"key":"2015080316492479000_36.29.1851.90","doi-asserted-by":"crossref","unstructured":"Nelson W . Graphical analysis of system repair data. J Qual Technol 1988;20:24\u201335.","DOI":"10.1080\/00224065.1988.11979080"},{"key":"2015080316492479000_36.29.1851.91","doi-asserted-by":"publisher","DOI":"10.1214\/aos\/1176345976"},{"key":"2015080316492479000_36.29.1851.92","doi-asserted-by":"publisher","DOI":"10.1191\/0962280202sm278ra"},{"key":"2015080316492479000_36.29.1851.93","doi-asserted-by":"publisher","DOI":"10.1093\/aje\/153.3.232"},{"key":"2015080316492479000_36.29.1851.94","doi-asserted-by":"publisher","DOI":"10.1016\/S0951-8320(02)00049-2"},{"key":"2015080316492479000_36.29.1851.95","doi-asserted-by":"publisher","DOI":"10.1002\/bimj.201200018"},{"key":"2015080316492479000_36.29.1851.96","doi-asserted-by":"crossref","unstructured":"Diggle PJ Heagerty P Liang K-Y Analysis of Longitudinal Data. 2nd edition. Oxford, United Kingdom: Oxford University Press, 2002.","DOI":"10.1093\/oso\/9780198524847.001.0001"},{"key":"2015080316492479000_36.29.1851.97","doi-asserted-by":"publisher","DOI":"10.1016\/j.jclinepi.2006.10.020"},{"key":"2015080316492479000_36.29.1851.98","doi-asserted-by":"publisher","DOI":"10.1002\/sim.2716"},{"key":"2015080316492479000_36.29.1851.99","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/ehr352"},{"key":"2015080316492479000_36.29.1851.100","doi-asserted-by":"publisher","DOI":"10.1016\/S0197-2456(96)00129-8"},{"key":"2015080316492479000_36.29.1851.101","doi-asserted-by":"publisher","DOI":"10.1002\/(SICI)1097-0258(19990615)18:11<1341::AID-SIM129>3.0.CO;2-7"},{"key":"2015080316492479000_36.29.1851.102","doi-asserted-by":"publisher","DOI":"10.1002\/sim.4199"},{"key":"2015080316492479000_36.29.1851.103","unstructured":"Castaneda J Gerritse B . Appraisal of several methods to model time to multiple events per subject: modeling time to hospitalizations and death. Revista Colombiana de Estadistica 2010:43\u201361."}],"container-title":["European Heart Journal"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/academic.oup.com\/eurheartj\/article-pdf\/36\/29\/1851\/17154759\/ehv281.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,6,9]],"date-time":"2024-06-09T19:33:21Z","timestamp":1717961601000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/eurheartj\/article-lookup\/doi\/10.1093\/eurheartj\/ehv281"}},"subtitle":["A consensus document from the mitral valve academic research consortium"],"short-title":[],"issued":{"date-parts":[[2015,7,13]]},"references-count":103,"journal-issue":{"issue":"29","published-online":{"date-parts":[[2015,8,3]]},"published-print":{"date-parts":[[2015,8,1]]}},"alternative-id":["10.1093\/eurheartj\/ehv281"],"URL":"https:\/\/doi.org\/10.1093\/eurheartj\/ehv281","relation":{"has-review":[{"id-type":"doi","id":"10.3410\/f.725634694.793519211","asserted-by":"object"}]},"ISSN":["0195-668X","1522-9645"],"issn-type":[{"value":"0195-668X","type":"print"},{"value":"1522-9645","type":"electronic"}],"subject":[],"published":{"date-parts":[[2015,7,13]]}}}