[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04688190":3,"trial-entities:NCT04688190":576,"trial-summary:NCT04688190":582},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":23,"primary_purpose":17,"phases":24,"enrollment_info":25,"interventions":28,"primary_outcomes":29,"secondary_outcomes":37,"sex":59,"minimum_age":60,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":61,"std_ages":69,"locations":72,"central_contacts":542,"overall_officials":550,"references":561,"see_also_links":575},"NCT04688190","CHOICE-MI","CHoice of OptImal transCatheter trEatment for Mitral Insufficiency Registry","Choice of Optimal Transcatheter Treatment for Mitral Insufficiency Registry","RECRUITING","2030-12-31","2026-05","2026-05-07","2020-11-01","Universitätsklinikum Hamburg-Eppendorf","OTHER",false,"This multinational, investigator-initiated registry aims to investigate clinical outcomes of patients undergoing transcatheter mitral valve replacement (TMVR). The registry primarily focuses on patients treated with TMVR in real-world clinical practice.\n\nPatients evaluated for TMVR but not undergoing the procedure are no longer systematically included. Historical data may include such patients who subsequently underwent alternative treatments, including transcatheter edge-to-edge repair, mitral valve surgery, or medical\u002Fconservative therapy.",null,[19,20,21],"Mitral Regurgitation","Mitral Valve Disease","Mitral Annular Calcification",[],"OBSERVATIONAL",[],{"count":26,"type":27},1000,"ESTIMATED",[],[30,34],{"measure":31,"description":32,"timeFrame":33},"Mitral insufficiency grade 2+ or more","Mitral insufficiency measured by transthoracic echocardiography. Assessment of MI severity according to current guidelines (ESC\u002FEACTS and ACC\u002FAHA) for valvular heart disease.","12 months",{"measure":35,"timeFrame":36},"Freedom from device-related complications","30 days",[38,40,42,44,47,49,52,54,56],{"measure":39,"timeFrame":33},"Combined all-cause mortality or rehospitalization for congestive heart failure",{"measure":41,"timeFrame":33},"All-cause mortality",{"measure":43,"timeFrame":33},"Cardiovascular mortality",{"measure":45,"description":46,"timeFrame":33},"Rehospitalization for congestive heart failure","Incidence of new-onset or worsening signs and symptoms of heart failure that required urgent therapy and resulted in hospitalization, e.g. as assessed by patient interviews.",{"measure":48,"timeFrame":33},"Combined cardiovascular mortality or rehospitalization for congestive heart failure",{"measure":50,"description":51,"timeFrame":33},"Unplanned mitral valve intervention","Incidence of unplanned surgical or transcatheter re-intervention, heart transplantation or left ventricular assist device implantation, e.g. as assessed by patient interviews.",{"measure":53,"timeFrame":33},"Combined all-cause mortality, rehospitalization for congestive heart failure or unplanned mitral valve intervention",{"measure":55,"timeFrame":33},"Combined cardiovascular mortality, rehospitalization for congestive heart failure or unplanned mitral valve intervention",{"measure":57,"description":58,"timeFrame":33},"New York Heart Association (NYHA) stage III or IV","Assessment of New York Heart Association (NYHA) classification stage (in- or outpatient) after 12 months follow-up, as assessed by patient interviews.","ALL","18 Years",{"inclusion":62,"exclusion":67,"raw_text":68},[63,64,65,66],"clinically significant mitral insufficiency","patient underwent screening for TMVI","echocardiography data at baseline (and after TMVI, E2E and surgery)","follow-up of at least 30 days",[],"Inclusion Criteria:\n\n* clinically significant mitral insufficiency\n* patient underwent screening for TMVI\n* echocardiography data at baseline (and after TMVI, E2E and surgery)\n* follow-up of at least 30 days\n\nExclusion Criteria:\n\n\\- age under 18 years",[70,71],"ADULT","OLDER_ADULT",[73,88,101,114,127,140,153,167,180,191,201,213,227,236,245,255,265,274,283,292,304,315,326,335,344,355,366,377,388,394,405,417,429,438,449,457,468,478,490,501,513,524,534],{"facility":74,"status":8,"city":75,"state":76,"zip":77,"country":78,"contacts":79,"geoPoint":85},"Tucson Medical Center","Tucson","Arizona","85712","United States",[80],{"name":81,"role":82,"phone":83,"email":84},"Thomas E. Waggoner","CONTACT","+1 520-327-5461","info@tmcaz.com",{"lat":86,"lon":87},32.22174,-110.92648,{"facility":89,"status":8,"city":90,"state":91,"zip":92,"country":78,"contacts":93,"geoPoint":98},"Cedars-Sinai Medical Center, Los Angeles","Los Angeles","California","90048",[94,96],{"name":95,"role":82},"Raj Makkar, MD",{"name":97,"role":82},"Sung-Han Yoon, MD",{"lat":99,"lon":100},34.05223,-118.24368,{"facility":102,"status":8,"city":103,"state":104,"zip":105,"country":78,"contacts":106,"geoPoint":111},"Tampa General Hospital","Tampa","Florida","33606",[107],{"name":108,"role":82,"phone":109,"email":110},"Hiram G. Bezerra, MD","+1 813-844-7000","info@tgh.org",{"lat":112,"lon":113},27.94752,-82.45843,{"facility":115,"status":8,"city":116,"state":117,"zip":118,"country":78,"contacts":119,"geoPoint":124},"Brigham and Women's Hospital","Boston","Massachusetts","02115",[120,122],{"name":121,"role":82},"Tsuyoshi Kaneko, MD",{"name":123,"role":82},"Pinak Shah, MD",{"lat":125,"lon":126},42.35843,-71.05977,{"facility":128,"status":8,"city":129,"state":130,"zip":131,"country":78,"contacts":132,"geoPoint":137},"Minneapolis Heart Institute at Abbott Northwestern Hospital","Minneapolis","Minnesota","55407",[133],{"name":134,"role":82,"phone":135,"email":136},"Paul Sorajja, MD","+1 612-863-4000","info@allina.com",{"lat":138,"lon":139},44.97997,-93.26384,{"facility":141,"status":8,"city":142,"state":143,"zip":144,"country":78,"contacts":145,"geoPoint":150},"Morristown Medical Center","Morristown","New Jersey","07960",[146],{"name":147,"role":82,"phone":148,"email":149},"Philippe Généreux, MD","+1 973-971-5000","philippegenereux@gmail.com",{"lat":151,"lon":152},40.79677,-74.48154,{"facility":154,"status":8,"city":155,"state":155,"zip":156,"country":78,"contacts":157,"geoPoint":164},"Montefiore Medical Center","New York","10461",[158,162],{"name":159,"role":82,"phone":160,"email":161},"Azeem Latib, MD","+1 718-920-4321","mlatib@montefiore.org",{"name":163,"role":82,"phone":160},"Andrea Scotti, MD",{"lat":165,"lon":166},40.71427,-74.00597,{"facility":168,"status":8,"city":169,"state":170,"zip":171,"country":78,"contacts":172,"geoPoint":177},"Oklahoma Heart Hospital","Oklahoma City","Oklahoma","73120",[173],{"name":174,"role":82,"phone":175,"email":176},"Naeem Tahirkheli, MD","+1 405-608-3200","ntahirkheli@okheart.com",{"lat":178,"lon":179},35.46756,-97.51643,{"facility":181,"status":8,"city":182,"state":183,"zip":184,"country":78,"contacts":185,"geoPoint":188},"Houston Methodist Hospital","Houston","Texas","77030",[186],{"name":187,"role":82},"Michael Reardon, MD",{"lat":189,"lon":190},29.76328,-95.36327,{"facility":192,"status":8,"city":193,"country":194,"contacts":195,"geoPoint":198},"St Vincent's Hospital","Sydney","Australia",[196],{"name":197,"role":82},"David Muller, MD",{"lat":199,"lon":200},-33.86785,151.20732,{"facility":202,"status":8,"city":203,"country":204,"contacts":205,"geoPoint":210},"Medical University of Vienna","Vienna","Austria",[206],{"name":207,"role":82,"phone":208,"email":209},"Martin Andreas, Prof","+43 1-40400-0","info@meduniwien.ac.at",{"lat":211,"lon":212},48.20849,16.37208,{"facility":214,"status":8,"city":215,"state":216,"zip":217,"country":218,"contacts":219,"geoPoint":224},"Québec Heart and Lung Institute (Laval University)","Québec","Quebec","G1V 4G5","Canada",[220],{"name":221,"role":82,"phone":222,"email":223},"Rodés-Cabau Josep, MD","+1 418-656-8711","info@icm.qc.ca",{"lat":225,"lon":226},46.81228,-71.21454,{"facility":228,"status":8,"city":229,"country":218,"contacts":230,"geoPoint":233},"Toronto Heart Center","Toronto",[231],{"name":232,"role":82},"Neil Fam, MD",{"lat":234,"lon":235},43.70643,-79.39864,{"facility":237,"status":8,"city":238,"country":218,"contacts":239,"geoPoint":242},"St. Paul's Hospital","Vancouver",[240],{"name":241,"role":82},"John G Webb, MD",{"lat":243,"lon":244},49.24966,-123.11934,{"facility":246,"status":8,"city":247,"country":248,"contacts":249,"geoPoint":252},"Rigshospitalet","Copenhagen","Denmark",[250],{"name":251,"role":82},"Lars Sondergaard, MD",{"lat":253,"lon":254},55.67594,12.56553,{"facility":256,"status":8,"city":257,"country":258,"contacts":259,"geoPoint":262},"CHU Bordeaux","Bourdeaux","France",[260],{"name":261,"role":82},"Thomas Modine, MD",{"lat":263,"lon":264},44.58582,5.13611,{"facility":266,"status":8,"city":267,"country":258,"contacts":268,"geoPoint":271},"Lille University Hospital","Lille",[269],{"name":270,"role":82},"Augustin Coisne, MD",{"lat":272,"lon":273},50.63391,3.05512,{"facility":275,"status":8,"city":276,"country":258,"contacts":277,"geoPoint":280},"Civils Hospices of Lyon","Lyon",[278],{"name":279,"role":82},"Jean-Francois Obadia, MD",{"lat":281,"lon":282},45.74906,4.84789,{"facility":284,"status":8,"city":285,"country":258,"contacts":286,"geoPoint":289},"Clinique Pasteur","Toulouse",[287],{"name":288,"role":82},"Nicolas Dumonteil, MD",{"lat":290,"lon":291},43.60426,1.44367,{"facility":293,"status":8,"city":294,"country":295,"contacts":296,"geoPoint":301},"HDZ Bad Oeynhausen","Bad Oeynhausen","Germany",[297,299],{"name":298,"role":82},"Tanja Rudolph, MD",{"name":300,"role":82},"Sabine Bleiziffer, MD",{"lat":302,"lon":303},52.20699,8.80365,{"facility":305,"status":8,"city":306,"country":295,"contacts":307,"geoPoint":312},"German Heart Center Berlin","Berlin",[308,310],{"name":309,"role":82},"Jörg Kempfert, MD",{"name":311,"role":82},"Axel Unbehaun, MD",{"lat":313,"lon":314},52.52437,13.41053,{"facility":316,"status":8,"city":317,"country":295,"contacts":318,"geoPoint":323},"Heart Center Bonn","Bonn",[319,321],{"name":320,"role":82},"Georg Nickenig, MD",{"name":322,"role":82},"Marcel Weber, MD",{"lat":324,"lon":325},50.73438,7.09549,{"facility":327,"status":8,"city":328,"country":295,"contacts":329,"geoPoint":332},"University Hospital of Cologne","Cologne",[330],{"name":331,"role":82},"Matti Adam, MD",{"lat":333,"lon":334},50.93333,6.95,{"facility":336,"status":8,"city":337,"country":295,"contacts":338,"geoPoint":341},"Goethe-Universität - University Hospital Frankfurt","Frankfurt",[339],{"name":340,"role":82},"Thomas Walther, MD",{"lat":342,"lon":343},49.68333,10.53333,{"facility":345,"status":8,"city":346,"country":295,"contacts":347,"geoPoint":352},"University Heart and Vascular Center Hamburg","Hamburg",[348,350],{"name":349,"role":82},"Sebastian Ludwig, MD",{"name":349,"role":351},"PRINCIPAL_INVESTIGATOR",{"lat":353,"lon":354},53.55073,9.99302,{"facility":356,"status":8,"city":357,"country":295,"contacts":358,"geoPoint":363},"University Heart Center Lübeck","Lübeck",[359],{"name":360,"role":82,"phone":361,"email":362},"Christian Frerker, MD","+49 451-500-0","info@uksh.de",{"lat":364,"lon":365},53.86893,10.68729,{"facility":367,"status":8,"city":368,"country":295,"contacts":369,"geoPoint":374},"Heart Center of the University Medical Center Mainz","Mainz",[370],{"name":371,"role":82,"phone":372,"email":373},"Philipp Lurz, Prof","+49 6131 170","kardiologie@unimedizin-mainz.de",{"lat":375,"lon":376},49.98185,8.28008,{"facility":378,"status":8,"city":379,"country":295,"contacts":380,"geoPoint":385},"German Heart Centre Munich","Munich",[381,383],{"name":382,"role":82},"Hendrik Ruge, MD",{"name":384,"role":82},"Rüdiger Lange, MD",{"lat":386,"lon":387},48.13743,11.57549,{"facility":389,"status":8,"city":379,"country":295,"contacts":390,"geoPoint":393},"LMU Munich",[391],{"name":392,"role":82},"Jörg Hausleiter, MD",{"lat":386,"lon":387},{"facility":395,"status":8,"city":396,"country":295,"contacts":397,"geoPoint":402},"University Medical Center Ulm","Ulm",[398],{"name":399,"role":82,"phone":400,"email":401},"Mirjam Keßler, Prof","+49 731-500-0","info@uniklinik-ulm.de",{"lat":403,"lon":404},48.39841,9.99155,{"facility":406,"status":8,"city":407,"country":408,"contacts":409,"geoPoint":414},"Interbalkan Medical Center","Thessaloniki","Greece",[410],{"name":411,"role":82,"phone":412,"email":413},"Vlasis Ninios, MD","+30 2310-400000","info@interbalkan.gr",{"lat":415,"lon":416},40.64072,22.93493,{"facility":418,"status":8,"city":419,"country":420,"contacts":421,"geoPoint":426},"ASST Spedali Civili di Brescia","Brescia","Italy",[422],{"name":423,"role":82,"phone":424,"email":425},"Marianna Adamo, MD","+39 030-39951","protocollo@pec.asst-spedalicivili.it",{"lat":427,"lon":428},45.53558,10.21472,{"facility":430,"status":8,"city":431,"country":420,"contacts":432,"geoPoint":435},"San Raffaele University Hospital","Milan",[433],{"name":434,"role":82},"Paolo Denti, MD",{"lat":436,"lon":437},45.46427,9.18951,{"facility":439,"status":8,"city":431,"zip":440,"country":420,"contacts":441,"geoPoint":446},"IRCCS Humanitas Research Hospital","20089",[442],{"name":443,"role":82,"phone":444,"email":445},"Antonio Mangieri, MD","+39 02-8224-1","info@humanitas.it",{"lat":447,"lon":448},42.78235,12.59836,{"facility":450,"status":8,"city":431,"country":420,"contacts":451,"geoPoint":456},"IRCCS Policlinico San Donato",[452],{"name":453,"role":82,"phone":454,"email":455},"Andrea Garatti, MD","+39 02-5277-1","info@grupposandonato.it",{"lat":447,"lon":448},{"facility":458,"status":8,"city":459,"country":420,"contacts":460,"geoPoint":465},"University Hospital of Pisa","Pisa",[461],{"name":462,"role":82,"phone":463,"email":464},"Cristina Giannini, MD","+39 050-992111","urp@ao-pisa.toscana.it",{"lat":466,"lon":467},43.70853,10.4036,{"facility":469,"status":8,"city":470,"country":471,"contacts":472,"geoPoint":475},"Rikshospitalet, Oslo University Hospital (OUS)","Oslo","Norway",[473],{"name":474,"role":82},"Gry Dahle, MD",{"lat":476,"lon":477},59.91273,10.74609,{"facility":479,"status":8,"city":480,"country":481,"contacts":482,"geoPoint":487},"Poznan University of Medical Sciences","Poznan","Poland",[483],{"name":484,"role":82,"phone":485,"email":486},"Marek Grygier","+48 61-854-6000","info@ump.edu.pl",{"lat":488,"lon":489},52.40692,16.92993,{"facility":491,"status":8,"city":492,"country":481,"contacts":493,"geoPoint":498},"Warsaw Medicover Hospital","Warsaw",[494],{"name":495,"role":82,"phone":496,"email":497},"Krzysztof Wróbel","+48 22-431-8100","info@medicover.pl",{"lat":499,"lon":500},52.22977,21.01178,{"facility":502,"status":8,"city":503,"country":504,"contacts":505,"geoPoint":510},"Inselspital Bern","Bern","Switzerland",[506,508],{"name":507,"role":82},"Fabien Praz, MD",{"name":509,"role":82},"Mirjam Wild, MD",{"lat":511,"lon":512},46.94809,7.44744,{"facility":514,"status":8,"city":515,"country":504,"contacts":516,"geoPoint":521},"USZ Zurich","Zurich",[517,519],{"name":518,"role":82},"Alberto Pozzoli, MD",{"name":520,"role":82},"Maurizio Taramasso, MD",{"lat":522,"lon":523},47.36667,8.55,{"facility":525,"status":8,"city":526,"country":527,"contacts":528,"geoPoint":531},"Royal Brompton Hospital","London","United Kingdom",[529],{"name":530,"role":82},"Alison Duncan, MD",{"lat":532,"lon":533},51.50853,-0.12574,{"facility":535,"status":8,"city":526,"country":527,"contacts":536,"geoPoint":541},"St Thomas' Hospital - London",[537,539],{"name":538,"role":82},"Simon Redwood, MD",{"name":540,"role":82},"Omar Chehab, MD",{"lat":532,"lon":533},[543,546],{"name":349,"role":82,"phone":544,"email":545},"+494074100","se.ludwig@uke.de",{"name":547,"role":82,"phone":548,"email":549},"Lena Strotmann, MD","+4074100","L.Strotmann@uke.de",[551,554,556,558],{"name":552,"affiliation":553,"role":351},"Lenard Conradi, MD","University of Cologne",{"name":261,"affiliation":555,"role":351},"University Hospital, Bordeaux",{"name":349,"affiliation":557,"role":351},"University Heart and Vascular Center Hamburg, University Medical Center Hamburg-Eppendorf",{"name":559,"affiliation":560,"role":351},"Juan F Granada, MD","Cardiovascular Research Foundation, New York, USA",[562,566,569,572],{"pmid":563,"type":564,"citation":565},"42575577","DERIVED","Strotmann L, Scotti A, Coisne A, Heinze A, Stolz L, von Stein P, Ben Ali W, Succar C, Regazzoli D, Kessler M, Duncan A, Rudolph TK, Heide IV, Schulz C, Koll B, Kalbacher D, Schofer N, Nickenig G, Ruge H, Adam M, Giannini C, de Backer O, Adamo M, Garatti A, Frerker C, Stiermaier T, Dahle G, Taramasso M, Walther T, Kempfert J, Dumonteil N, Obadia JF, Tahirkheli N, Grygier M, Genereux P, Bezerra HG, Wrobel K, Waggoner TE, Andreas M, Redwood S, Tang GHL, Reardon M, Sorajja P, Fam N, Muller DW, Praz F, von Bardeleben RS, Hausleiter J, Mangieri A, Ninios V, Denti P, Rottbauer W, Webb JG, Blankenberg S, Rodes-Cabau J, Latib A, Granada JF, Conradi L, Modine T, Ludwig S; CHOICE-MI Investigators. Clinical Outcomes of Transfemoral Transcatheter Mitral Valve Replacement: Results From the CHOICE-MI Registry. JACC Cardiovasc Interv. 2026 Aug 10;19(15):2080-2094. doi: 10.1016\u002Fj.jcin.2026.05.003. Epub 2026 May 20.",{"pmid":567,"type":564,"citation":568},"40329826","Ludwig S, Coisne A, Hamzi K, Ben Ali W, Scotti A, Koell B, Duncan A, Makkar R, Akodad M, Bleiziffer S, Nickenig G, Kaneko T, Ruge H, Adam M, Sondergaard L, Dahle G, Taramasso M, Walther T, Kempfert J, Obadia JF, Chehab O, Tang GHL, Goel S, Fam N, Denti P, Praz F, von Bardeleben RS, Hausleiter J, Latib A, Conradi L, Modine T, Pezel T, Granada JF; CHOICE-MI Investigators. Phenotypic clustering analysis of patients rejected for mitral valve interventions: implications for future transcatheter technologies. Eur Heart J Cardiovasc Imaging. 2025 Jul 31;26(8):1452-1463. doi: 10.1093\u002Fehjci\u002Fjeaf141.",{"pmid":570,"type":564,"citation":571},"39243262","Coisne A, Ludwig S, Scotti A, Ben Ali W, Weimann J, Duncan A, Webb JG, Kalbacher D, Rudolph TK, Nickenig G, Hausleiter J, Ruge H, Adam M, Petronio AS, Dumonteil N, Sondergaard L, Adamo M, Regazzoli D, Garatti A, Schmidt T, Dahle G, Taramasso M, Walther T, Kempfert J, Obadia JF, Redwood S, Tang GHL, Goel S, Fam N, Metra M, Andreas M, Muller DW, Denti P, Praz F, von Bardeleben RS, Leroux L, Latib A, Granada JF, Conradi L, Modine T; CHOICE-MI Investigators. Outcomes Following Transcatheter Mitral Valve Replacement Using Dedicated Devices in Patients With Mitral Annular Calcification. JACC Cardiovasc Interv. 2024 Sep 23;17(18):2141-2153. doi: 10.1016\u002Fj.jcin.2024.07.038. Epub 2024 Sep 4.",{"pmid":573,"type":564,"citation":574},"37194288","Ludwig S, Conradi L, Cohen DJ, Coisne A, Scotti A, Abraham WT, Ben Ali W, Zhou Z, Li Y, Kar S, Duncan A, Lim DS, Adamo M, Redfors B, Muller DWM, Webb JG, Petronio AS, Ruge H, Nickenig G, Sondergaard L, Adam M, Regazzoli D, Garatti A, Schmidt T, Andreas M, Dahle G, Walther T, Kempfert J, Tang GHL, Redwood S, Taramasso M, Praz F, Fam N, Dumonteil N, Obadia JF, von Bardeleben RS, Rudolph TK, Reardon MJ, Metra M, Denti P, Mack MJ, Hausleiter J, Asch FM, Latib A, Lindenfeld J, Modine T, Stone GW, Granada JF; CHOICE-MI and the COAPT Trial Investigators. Transcatheter Mitral Valve Replacement Versus Medical Therapy for Secondary Mitral Regurgitation: A Propensity Score-Matched Comparison. Circ Cardiovasc Interv. 2023 Jun;16(6):e013045. doi: 10.1161\u002FCIRCINTERVENTIONS.123.013045. Epub 2023 May 16.",[],{"nct_id":4,"conditions":577,"biomarkers":581},[578,579,580],"Mitral Valve Disorder","Mitral Valve Insufficiency","Premature calcification of mitral annulus",[],{"nct_id":4,"found":583,"summary":584,"prompt_version":593},true,{"design":585,"status":586,"heading":6,"summary":587,"follow_up":588,"word_count":589,"commitments":590,"compensation":591,"drugs_mentioned":592},"This is an observational study that plans to include about 1000 participants. It is designed to collect information about patients undergoing TMVR in real-world settings.","completed","This study is a registry looking at the results for patients who have a procedure called transcatheter mitral valve replacement (TMVR) for mitral insufficiency (a heart valve problem where blood leaks backward). The registry will collect information from patients in real-world medical practice. To join, you must have significant mitral insufficiency, have been screened for TMVR, and have heart ultrasound (echocardiography) data. The study will look at how well the TMVR procedure works by checking if your mitral insufficiency is still significant after 12 months, and if you have any device-related problems within 30 days. The current status of this study is unclear.","The study will follow participants for at least 30 days, with a primary check on mitral insufficiency at 12 months.",103,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]