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Mitral surgery may be performed via a sternotomy or a right thoracotomy approach with or without robotic assistance.",[13,14,15],"Procedure: Cardiac Magnetic Resonance Imaging","Device: ZioPatch Monitoring","Procedure: Myocardial Tissue Biopsy",{"label":17,"type":10,"description":18,"interventionNames":19},"Transcatheter edge-to-edge repair","Patients will be treated with a commercially-approved edge-to-edge mitral repair device.",[13,14],[21,28,35],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Cardiac Magnetic Resonance Imaging","Non-invasive imaging test that uses powerful magnets and radio waves to create detailed pictures of the heart without using radiation.",[9,17],[27],"CMR",{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"DEVICE","ZioPatch Monitoring","ZioPatch is a small, wearable heart monitor that sticks to the chest and records the heart's electrical activity continuously for up to 14 days. It helps doctors detect irregular heart rhythms (arrhythmias) without the need for bulky wires or equipment.",[9,17],[34],"iRhythm Monitoring",{"type":22,"name":36,"description":37,"armGroupLabels":38,"otherNames":39},"Myocardial Tissue Biopsy","During the MVr procedure, surgeons will biopsy approximately 50 μg of tissue from the endocardial and subendocardial myocardium in the inferobasilar and control areas using a surgical rongeur.",[9],[40],"Heart Bioplsy",[42,46],{"name":43,"affiliation":44,"role":45},"Joanna Chikwe, MD","Cedars-Sinai","STUDY_DIRECTOR",{"name":47,"affiliation":48,"role":45},"Martin Leon, MD","Columbia University",[50,56],{"name":51,"role":52,"phone":53,"phoneExt":54,"email":55},"Chari Ponder, RN, BSN","CONTACT","(646) 899-8106",null,"chari.ponder@mountsinai.org",{"name":57,"role":52,"phone":58,"phoneExt":54,"email":59},"Jonathan Hupf","(646) 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Palmeri","Monica.Palmeri@mainehealth.org",{"name":153,"role":81,"phone":54,"phoneExt":54,"email":54},"Robert Kramer, MD",{"facility":155,"status":63,"city":156,"state":157,"zip":158,"country":67,"countryCode":68,"cosmosGeoPoint":159,"geoPoint":163,"contacts":164},"The Johns Hopkins Hospital","Baltimore","Maryland","21287",{"type":70,"coordinates":160},[161,162],-76.61219,39.29038,{"lat":162,"lon":161},[165,167],{"name":166,"role":52,"phone":54,"phoneExt":54,"email":54},"Zyriah Robinson",{"name":168,"role":81,"phone":54,"phoneExt":54,"email":54},"James Gammie, MD",{"facility":170,"status":63,"city":171,"state":172,"zip":173,"country":67,"countryCode":68,"cosmosGeoPoint":174,"geoPoint":178,"contacts":179},"Massachusetts General Hospital","Boston","Massachusetts","02114",{"type":70,"coordinates":175},[176,177],-71.05977,42.35843,{"lat":177,"lon":176},[180,183],{"name":181,"role":52,"phone":54,"phoneExt":54,"email":182},"Patrick Udeh","pudeh@mgh.harvard.edu",{"name":184,"role":81,"phone":54,"phoneExt":54,"email":54},"Serguei Melnitchouk, MD",{"facility":186,"status":63,"city":187,"state":188,"zip":189,"country":67,"countryCode":68,"cosmosGeoPoint":190,"geoPoint":194,"contacts":195},"University of Michigan Hospital","Ann Arbor","Michigan","48109",{"type":70,"coordinates":191},[192,193],-83.74088,42.27756,{"lat":193,"lon":192},[196,199],{"name":197,"role":52,"phone":54,"phoneExt":54,"email":198},"Nicole White","nlaniece@med.umich.edu",{"name":200,"role":81,"phone":54,"phoneExt":54,"email":54},"Gorav Ailawadi",{"facility":202,"status":63,"city":203,"state":204,"zip":205,"country":67,"countryCode":68,"cosmosGeoPoint":206,"geoPoint":210,"contacts":211},"Saint Luke's Hospital of Kansas City\u002FMidAmerica Heart and Lung Surgeons","Kansas City","Missouri","64111",{"type":70,"coordinates":207},[208,209],-94.57857,39.09973,{"lat":209,"lon":208},[212,215],{"name":213,"role":52,"phone":54,"phoneExt":54,"email":214},"Diane Peterman","dpeterman@saint-lukes.org",{"name":216,"role":81,"phone":54,"phoneExt":54,"email":54},"Keith Allen, MD",{"facility":218,"status":63,"city":219,"state":219,"zip":220,"country":67,"countryCode":68,"cosmosGeoPoint":221,"geoPoint":225,"contacts":226},"Weill Cornell Medicine\u002F New York-Presbyterian Hospital","New York","10065",{"type":70,"coordinates":222},[223,224],-74.00597,40.71427,{"lat":224,"lon":223},[227,230,232],{"name":228,"role":52,"phone":54,"phoneExt":54,"email":229},"Marshagay Rodriques","mar4028@med.cornell.edu",{"name":231,"role":81,"phone":54,"phoneExt":54,"email":54},"Stephanie Mick, MD",{"name":233,"role":81,"phone":54,"phoneExt":54,"email":54},"Donald 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(0)30-4593-2204","andreas.bader-woelfle@dhzc-charite.de",{"name":327,"role":81,"phone":54,"phoneExt":54,"email":54},"Volkmar Falk",{"facility":329,"status":63,"city":330,"state":54,"zip":331,"country":314,"countryCode":315,"cosmosGeoPoint":332,"geoPoint":336,"contacts":337},"Herzzentrum Leipzig","Leipzig","04289",{"type":70,"coordinates":333},[334,335],12.37129,51.33962,{"lat":335,"lon":334},[338,339],{"name":323,"role":52,"phone":324,"phoneExt":54,"email":325},{"name":340,"role":81,"phone":54,"phoneExt":54,"email":54},"Michael Borger",{"facility":342,"status":63,"city":343,"state":344,"zip":54,"country":345,"countryCode":346,"cosmosGeoPoint":347,"geoPoint":351,"contacts":352},"Royal Papworth Hospital NHS Foundation Trust","Trumpington","Cambridge","United Kingdom","UK",{"type":70,"coordinates":348},[349,350],0.11261,52.17214,{"lat":350,"lon":349},[353,356],{"name":354,"role":52,"phone":54,"phoneExt":54,"email":355},"Louise Steel","louise.steel7@nhs.net",{"name":357,"role":81,"phone":54,"phoneExt":54,"email":54},"Patrick Calvert",{"facility":359,"status":63,"city":360,"state":361,"zip":362,"country":345,"countryCode":346,"cosmosGeoPoint":363,"geoPoint":367,"contacts":368},"The Leeds Teaching Hospitals NHS Trust","Leeds","England","LS9 7TF",{"type":70,"coordinates":364},[365,366],-1.54785,53.79648,{"lat":366,"lon":365},[369,370],{"name":354,"role":52,"phone":54,"phoneExt":54,"email":355},{"name":371,"role":81,"phone":54,"phoneExt":54,"email":54},"Chris Malkin",{"facility":373,"status":63,"city":374,"state":375,"zip":54,"country":345,"countryCode":346,"cosmosGeoPoint":376,"geoPoint":380,"contacts":381},"Barts Health NHS Trust","Whitechapel","London",{"type":70,"coordinates":377},[378,379],-0.06583,51.51382,{"lat":379,"lon":378},[382,383],{"name":354,"role":52,"phone":54,"phoneExt":54,"email":355},{"name":384,"role":81,"phone":54,"phoneExt":54,"email":54},"Dincer Aktuerk",{"facility":386,"status":63,"city":387,"state":388,"zip":54,"country":345,"countryCode":346,"cosmosGeoPoint":389,"geoPoint":393,"contacts":394},"Manchester University NHS Foundation Trust","Oxford","Manchester",{"type":70,"coordinates":390},[391,392],-1.25596,51.75222,{"lat":392,"lon":391},[395,396],{"name":354,"role":52,"phone":54,"phoneExt":54,"email":355},{"name":397,"role":81,"phone":54,"phoneExt":54,"email":54},"Mamta Buch",{"facility":399,"status":63,"city":400,"state":401,"zip":54,"country":345,"countryCode":346,"cosmosGeoPoint":402,"geoPoint":406,"contacts":407},"South Tees Hospitals NHS Foundation Trust","Marton-in-Cleveland","Middlesbrough",{"type":70,"coordinates":403},[404,405],-1.20257,54.5291,{"lat":405,"lon":404},[408,409],{"name":354,"role":52,"phone":54,"phoneExt":54,"email":355},{"name":410,"role":81,"phone":54,"phoneExt":54,"email":54},"Enoch Akowuah, MD",{"facility":412,"status":63,"city":387,"state":413,"zip":414,"country":345,"countryCode":346,"cosmosGeoPoint":415,"geoPoint":417,"contacts":418},"Oxford University Hospitals NHS Foundation Trust","Oxfordshire","OX3 9DU",{"type":70,"coordinates":416},[391,392],{"lat":392,"lon":391},[419,420],{"name":354,"role":52,"phone":54,"phoneExt":54,"email":355},{"name":421,"role":81,"phone":54,"phoneExt":54,"email":54},"Rana Sayeed",{"facility":423,"status":63,"city":424,"state":425,"zip":426,"country":345,"countryCode":346,"cosmosGeoPoint":427,"geoPoint":431,"contacts":432},"University Hospitals Sussex NHS Foundation Trust","Worthing","West Sussex","BN11 2DH",{"type":70,"coordinates":428},[429,430],-0.37538,50.81795,{"lat":430,"lon":429},[433,434],{"name":354,"role":52,"phone":54,"phoneExt":54,"email":355},{"name":435,"role":81,"phone":54,"phoneExt":54,"email":54},"Ish Ahmed",{"type":437,"investigatorFullName":438,"investigatorTitle":439,"investigatorAffiliation":5,"oldNameTitle":54,"oldOrganization":54},"SPONSOR_INVESTIGATOR","Annetine Gelijns","Department Chair, Department of Population Health Science & Policy Edmond A. Guggenheim Professor of Health Policy Co-Director, InCHOIR",[441],{"name":442,"class":443},"National Heart, Lung, and Blood Institute (NHLBI)","NIH","100600918","primary-ancillary-substudy-100600918",false,"NCT07103733","PRIMARY Ancillary Substudy","Percutaneous or Surgical Repair In Mitral Prolapse And Regurgitation for ≥60 Year-olds (PRIMARY) Ancillary Substudy","Inclusion Criteria:\n\n* Patients who meet all eligibility criteria and are randomized in the parent PRIMARY trial.\n* For the ancillary biospecimen study, patients who are randomized to MVr in the parent trial.\n\nExclusion Criteria:\n\n* Severe claustrophobia not controlled with sedation.\n* Prior adverse reaction to gadolinium administration.\n* Patients with an implantable subcutaneous cardioverter defibrillator and\u002For cardiac resynchronization therapy device with defibrillator may be excluded as they typically produce substantial artifacts on cardiac MRI making assessment very challenging.\n* Known allergic reaction to adhesives or hydrogels or with family history of adhesive skin allergies (for patients undergoing rhythm monitoring).","ALL","60 Years",{"count":454,"type":455},250,"ESTIMATED","INTERVENTIONAL",[458],"NA","The PRIMARY trial (NCT05051033), which compares mitral valve repair (MVr) to transcatheter-edge-to-edge-repair (TEER), offers a platform for conducting mechanistic studies to develop early insights into the pathophysiological processes by which mitral valve prolapse (MVP) can impact left ventricular (LV) myocardial structure and function, and, thereby, predispose to arrhythmias and sudden death. Such insights are key to identifying interventions to reduce the long-term sequelae of heart failure (HF) and arrhythmias, as well as delineate optimal therapeutic approaches for different patient sub-groups.",[461,462,463],"Mitral Valve Prolapse","Left Ventricular Fibrosis","Ventricular Arrhythmias",[465,466,467,468,469],"Mitral valve repair (MVr)","Transcatheter-edge-to-edge-repair (TEER)","Cardiac magnetic resonance imaging (CMR)","ZioPatch monitoring","Heart biopsy","2025-08-14",{"date":472,"type":473},"2025-08-19","ACTUAL",{"date":475,"type":473},"2023-10-16",{"date":477,"type":455},"2027-06-30",{"name":438,"class":6},25]