450
Participants
Start Date
February 21, 2022
Primary Completion Date
November 15, 2028
Study Completion Date
November 15, 2030
Mitral valve repair
Patients who are randomized to the surgical arm will undergo mitral surgery. Mitral surgery will be conducted using general anesthesia and cardiopulmonary bypass. Mitral surgery may be performed via a sternotomy or a right thoracotomy approach with or without robotic assistance. Standard techniques commonly include a ring or band annuloplasty to correct and prevent annular dilatation; leaflet prolapse and redundancy may be corrected by leaflet resection techniques and / or chordal reconstruction.
Transcatheter edge-to-edge repair
Patients will be treated with a commercially-approved edge-to-edge mitral repair device. The steerable guide catheter (guide) is inserted into the femoral vein and advanced across the inter-atrial septum using image guided puncture. Fluoroscopic and echocardiographic guidance will be used to visualize the devices and assess the repair. The guide is positioned over the MV and the clip/clasp delivery system is inserted into the guide and positioned over the MV in accordance with the manufacturer's instructions. The delivery catheter is advanced until the clip/clasp emerges from the tip of the guide into the left atrium. The catheter is manipulated using the control handle until the clip/clasp is correctly oriented with respect to the line of coaptation of the mitral valve. The clip/clasp is opened, and advanced across the mitral valve into the left ventricle then pulled back to grasp the leaflets.
RECRUITING
Nyph/Cumc, New York
RECRUITING
Weill Cornell Medicine/ New York-Presbyterian Hospital, New York
RECRUITING
Deutsches Herzzentrum der Charité, Berlin
RECRUITING
Hospital of the University of Pennsylvania, Philadelphia
RECRUITING
Asklepios Klinik St. Georg Hamburg, Hamburg
RECRUITING
Universitätsklinikum Hamburg Eppendorf, Hamburg
RECRUITING
The Johns Hopkins Hospital, Baltimore
RECRUITING
Northwell Health, New York
RECRUITING
University of Virginia Medical Center, Charlottesville
RECRUITING
Universitätsklinikum Schleswig-Holstein Campus Lübeck, Lübeck
RECRUITING
Universitätsklinikum Schleswig-Holstein Campus Kiel, Kiel
RECRUITING
West Virginia University Hospital, Morgantown
RECRUITING
Duke University Hospital, Durham
RECRUITING
Hospital Clínico San Carlos, Madrid
RECRUITING
Medical University of South Carolina, Charleston
RECRUITING
Piedmont Heart Institute, Atlanta
RECRUITING
Emory University, Atlanta
RECRUITING
Herz- und Diabeteszentrum NRW, Bad Oeynhausen
RECRUITING
Hospital Central de Asturias, Oviedo
RECRUITING
Hospital Alvaro Cunqueiro, Vigo
RECRUITING
Cleveland Clinic, Cleveland
RECRUITING
University of Michigan Hospital, Ann Arbor
RECRUITING
Schüchtermann-Klinik Bad Rothenfelde, Bad Rothenfelde
RECRUITING
Universitätsklinikum Köln, Cologne
RECRUITING
Universitätsklinikum Frankfurt, Frankfurt
RECRUITING
Kerckhoff Klinik Bad Nauheim, Bad Nauheim
RECRUITING
Saint Luke's Hospital of Kansas City/MidAmerica Heart and Lung Surgeons, Kansas City
RECRUITING
Universitätsklinikum Heidelberg, Heidelberg
RECRUITING
Ochsner Clinic, New Orleans
RECRUITING
Baylor, Scott and White, Dallas
RECRUITING
Universitätsklinikum Freiburg, Freiburg im Breisgau
RECRUITING
Deutsches Herzzentrum München, München
RECRUITING
Keck Hospital of the University of Southern California, Los Angeles
RECRUITING
Cedars Sinai Medical Center, Los Angeles
RECRUITING
University of California San Francisco, San Francisco
RECRUITING
Stanford University, Stanford
RECRUITING
Maine Medical Center, Portland
RECRUITING
Massachusetts General Hospital, Boston
RECRUITING
Brigham and Women's, Boston
RECRUITING
Dartmouth Hitchcock Medical Center, Lebanon
RECRUITING
University of British Columbia, Providence Health Care, St. Paul's Hospital, Vancouver
RECRUITING
London Health Sciences, London
RECRUITING
University of Ottawa Heart Institute, Ottawa
RECRUITING
Unity Health Toronto (St. Michael's Hospital), Toronto
RECRUITING
Institut Universitaire de Cardiologie et de Pneumologie de Quebec (Laval University), Québec
RECRUITING
Universitätsklinikum Jena, Jena
RECRUITING
Herzzentrum Leipzig, Leipzig
RECRUITING
Hospital Clinic De Barcelona, Barcelona
RECRUITING
Royal Papworth Hospital NHS Foundation Trust, Cambridge
RECRUITING
The Leeds Teaching Hospitals NHS Trust, Leeds
RECRUITING
St. Thomas Guy's and St Thomas' NHS Foundation Trust, London
RECRUITING
King's College Hospital NHS Foundation Trust, London
RECRUITING
Royal Brompton and Harefield Guy's and St Thomas' NHS Foundation Trust, London
RECRUITING
Manchester University NHS Foundation Trust, Manchester
RECRUITING
University Hospitals Sussex NHS Foundation Trust, Worthing
RECRUITING
University Hospitals Birmingham NHS Foundation Trust, Birmingham
RECRUITING
Golden Jubilee University National Hospital, Clydebank
RECRUITING
Oxford University Hospitals NHS Foundation Trust, Headington
RECRUITING
Barts Health NHS Trust, London
RECRUITING
South Tees Hospitals NHS Foundation Trust, Middlesbrough
RECRUITING
South Tees Hospital NHS Foundation Trust, Middlesbrough
National Heart, Lung, and Blood Institute (NHLBI)
NIH
Annetine Gelijns
OTHER