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.
This is a prospective, multicenter, open-label, randomized trial comparing mitral valve (MV) transcatheter edge-to-edge repair (TEER) to surgical repair (1:1 ratio) in patients with primary, degenerative mitral regurgitation (MR). The trial will be conducted in the U.S., Canada, Germany, Spain, and the United Kingdom, and is designed as a strategy trial. Thus, all devices legally marketed for TEER of primary degenerative MR in a particular country are eligible to be used in this trial.
| Facility | City | Region | Status |
|---|---|---|---|
| Keck Hospital of the University of Southern California | Los Angeles | California | |
| Cedars Sinai Medical Center | Los Angeles | California | |
| University of California San Francisco | San Francisco | California | |
| Stanford University | Stanford | California | |
| Piedmont Heart Institute | Atlanta | Georgia | |
| Emory University | Atlanta | Georgia | |
| Ochsner Clinic | New Orleans | Louisiana | |
| Maine Medical Center | Portland | Maine | |
| The Johns Hopkins Hospital | Baltimore | Maryland | |
| Massachusetts General Hospital | Boston | Massachusetts | |
| Brigham and Women's | Boston | Massachusetts | |
| University of Michigan Hospital | Ann Arbor | Michigan | |
| Saint Luke's Hospital of Kansas City/MidAmerica Heart and Lung Surgeons | Kansas City | Missouri | |
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | |
| New York-Presbyterian/Columbia University Medical Center | New York | New York | |
| Weill Cornell Medicine/ New York-Presbyterian Hospital | New York | New York | |
| Northwell Health | New York | New York | |
| Duke University Hospital | Durham | North Carolina | |
| Cleveland Clinic | Cleveland | Ohio | |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | |
| Medical University of South Carolina | Charleston | South Carolina | |
| Baylor, Scott and White | Dallas | Texas | |
| University of Virginia Medical Center | Charlottesville | Virginia | |
| West Virginia University Hospital | Morgantown | West Virginia | |
| University of British Columbia, Providence Health Care, St. Paul's Hospital | Vancouver | British Columbia | |
| London Health Sciences | London | Ontario | |
| University of Ottawa Heart Institute | Ottawa | Ontario | |
| Unity Health Toronto (St. Michael's Hospital) | Toronto | Ontario | |
| Institut Universitaire de Cardiologie et de Pneumologie de Quebec (Laval University) | Québec | Quebec | |
| Universitätsklinikum Köln | Cologne | Berlin-kölnische Allee | |
| Herz- und Diabeteszentrum NRW | Bad Oeynhausen | North Rhine-Westphalia | |
| Universitätsklinikum Köln | Cologne | North Rhine-Westphalia | |
| Kerckhoff Klinik Bad Nauheim | Bad Nauheim | Germany | |
| Schüchtermann-Klinik Bad Rothenfelde | Bad Rothenfelde | Germany | |
| Deutsches Herzzentrum der Charité | Berlin | Germany | |
| Universitätsklinikum Frankfurt | Frankfurt | Germany | |
| Universitätsklinikum Freiburg | Freiburg im Breisgau | Germany | |
| Asklepios Klinik St. Georg Hamburg | Hamburg | Germany | |
| Universitätsklinikum Hamburg Eppendorf | Hamburg | Germany | |
| Universitätsklinikum Heidelberg | Heidelberg | Germany |
+ 22 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05051033 on ClinicalTrials.gov ↗ ← All trials in Canada