New heart valve device offers hope for patients too sick for surgery

NCT ID NCT03242642

Recruiting now Disease control Sponsor: Medtronic Cardiovascular Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Aug 06, 2026 · Updated 4 times

Summary

This study tests a new device to replace the mitral valve in people with severe mitral regurgitation (a leaky heart valve) who cannot have standard surgery or a less invasive repair. About 1,056 participants will receive the device and be followed for safety and quality of life. The goal is to see if the device can control the disease and improve symptoms.

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Conditions

The condition(s) this trial relates to.

cardiovascular disorder heart disorder heart valve disorder mitral valve insufficiency

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

MITRAL VALVE REGURGITATION

Contacts and locations

Locations

Abbott Northwestern Hospital
RECRUITING

Minneapolis, Minnesota, 55407, United States
Abrazo Heart Hospital
RECRUITING

Phoenix, Arizona, 85018, United States
Aurora St. Luke's Medical Center
RECRUITING

Milwaukee, Wisconsin, 53215, United States
Baptist Medical Center Jacksonville
RECRUITING

Jacksonville, Florida, 32207, United States
Barnes-Jewish Hospital
RECRUITING

St Louis, Missouri, 63110-1003, United States
Baylor Jack and Jane Hamilton Heart and Vascular Hospital
WITHDRAWN

Dallas, Texas, 75246, United States
Beth Israel Deaconess Medical Center
RECRUITING

Boston, Massachusetts, 02215, United States
Brigham and Women's Hospital
RECRUITING

Boston, Massachusetts, 02115, United States
CHI Saint Luke's Health-Baylor Saint Luke's Medical Center
RECRUITING

Houston, Texas, 77030, United States
Carilion Roanoke Memorial Hospital
ACTIVE_NOT_RECRUITING

Roanoke, Virginia, 24014, United States
Cedars Sinai Medical Center
RECRUITING

Los Angeles, California, 90048, United States
Corewell Health
RECRUITING

Grand Rapids, Michigan, 49503, United States
Duke University Medical Center
WITHDRAWN

Durham, North Carolina, 27710, United States
El Camino Hospital
RECRUITING

Mountain View, California, 94040, United States
Emory University
RECRUITING

Atlanta, Georgia, 30308, United States
Glen Royal Victoria Hospital
RECRUITING

Montreal, Quebec, H4A 3J1, Canada
Hartford Hospital
RECRUITING

Hartford, Connecticut, 06102, United States
HealthPark Medical Center
RECRUITING

Fort Myers, Florida, 33908, United States
Heart Hospital of Austin
RECRUITING

Austin, Texas, 78756, United States
Henry Ford Saint John Hospital
RECRUITING

Detroit, Michigan, 48236, United States
Houston Methodist Hospital
RECRUITING

Houston, Texas, 77030, United States
Inova Fairfax Hospital
RECRUITING

Fairfax, Virginia, 22042, United States
Integris Baptist Medical Center
RECRUITING

Oklahoma City, Oklahoma, 73112, United States
JFK Medical Center
RECRUITING

Atlantis, Florida, 33462, United States
Jersey Shore University Medical Center
RECRUITING

Neptune City, New Jersey, 07753, United States
Kaiser Permanente Los Angeles Medical Center
RECRUITING

Los Angeles, California, 90027, United States
Kaiser Permanente San Francisco Medical Center
RECRUITING

San Francisco, California, 94118-3100, United States
Keck Hospital of the University of Southern California, USC
RECRUITING

Los Angeles, California, 90033, United States
Lankenau Medical Center
RECRUITING

Wynnewood, Pennsylvania, 19096, United States
Los Robles Regional Medical Center
RECRUITING

Thousand Oaks, California, 91360-1847, United States
M Health Fairview University of Minnesota Medical Center - East Bank
ACTIVE_NOT_RECRUITING

Minneapolis, Minnesota, 55455, United States
Massachusetts General Hospital
RECRUITING

Boston, Massachusetts, 02114, United States
MedStar Washington Hospital Center
RECRUITING

Washington D.C., District of Columbia, 20010, United States
MercyOne Des Moines Medical Center
RECRUITING

Des Moines, Iowa, 50314, United States
Methodist Hospital
RECRUITING

San Antonio, Texas, 78229, United States
Montefiore Medical Center
RECRUITING

New York, New York, 10467-2401, United States
Montreal Heart Insitute
RECRUITING

Montreal, Quebec, H1T 1C8, Canada
Morristown Medical Center
RECRUITING

Morristown, New Jersey, 07960, United States
Morton Plant
RECRUITING

Clearwater, Florida, 33756, United States
NYU Langone Hospital - Long Island
ACTIVE_NOT_RECRUITING

Mineola, New York, 11501, United States
NYU Langone Medical Center
RECRUITING

New York, New York, 10016, United States
New York-Presbyterian Hospital Columbia University Medical Center
ACTIVE_NOT_RECRUITING

New York, New York, 10032, United States
North Florida Regional Medical Center
RECRUITING

Gainesville, Florida, 32605, United States
Northwell Health North Shore University Hospital
RECRUITING

Manhasset, New York, 11030, United States
Northwestern Memorial Hospital
RECRUITING

Chicago, Illinois, 60611, United States
OhioHealth Riverside Methodist Hospital
RECRUITING

Columbus, Ohio, 43214, United States
Oregon Health & Science University Hospital
RECRUITING

Portland, Oregon, 97239, United States
PIH Health Good Samaritan Hospital
RECRUITING

Los Angeles, California, 90017, United States
Piedmont Atlanta Hospital
RECRUITING

Atlanta, Georgia, 30309, United States
Providence Sacred Heart Medical Center & Children's Hospital
RECRUITING

Spokane, Washington, 99204, United States
Providence Saint Vincent Medical Center
RECRUITING

Portland, Oregon, 97225, United States
Providence St Patrick
ACTIVE_NOT_RECRUITING

Missoula, Montana, 59802-4008, United States
Rigshospitalet
WITHDRAWN

Copenhagen, 2100, Denmark
Royal Columbian Hospital
RECRUITING

New Westminster, British Columbia, V3L 3W7, Canada
Rush University Medical Center
RECRUITING

Chicago, Illinois, 60612, United States
Saint Francis Hospital
RECRUITING

Roslyn, New York, 11576, United States
Saint Mary's Hospital/Bon Secours
WITHDRAWN

Richmond, Virginia, 23226, United States
Saint Michael's Hospital
RECRUITING

Toronto, Ontario, M5B 1W8, Canada
Saint Paul's Hospital
RECRUITING

Vancouver, British Columbia, V6Z 1Y6, Canada
Scripps Memorial Hospital
RECRUITING

La Jolla, California, 92037, United States
Sentara Norfolk General Hospital
RECRUITING

Norfolk, Virginia, 23507-1904, United States
Stanford Hospital and Clinics
RECRUITING

Stanford, California, 94305, United States
Sunnybrook Health Sciences Centre
RECRUITING

Toronto, Ontario, M4N 3M5, Canada
Texas Health Presbyterian Hospital Dallas
RECRUITING

Dallas, Texas, 75231, United States
The Christ Hospital
RECRUITING

Cincinnati, Ohio, 45219-2906, United States
The Heart Hospital Baylor Plano
RECRUITING

Plano, Texas, 75093, United States
The Johns Hopkins Hospital
RECRUITING

Baltimore, Maryland, 21287, United States
The Mount Sinai Hospital
RECRUITING

New York, New York, 10029, United States
The Ohio State University Wexner Medical Center
RECRUITING

Columbus, Ohio, 43210, United States
The Swedish Medical Center Cherry Hill
WITHDRAWN

Seattle, Washington, 98122, United States
The University of Texas Health Science Center at Houston
RECRUITING

Houston, Texas, 77030, United States
The University of Vermont Medical Center
RECRUITING

Burlington, Vermont, 05401-1473, United States
UPMC Pinnacle Harrisburg Campus
RECRUITING

Harrisburg, Pennsylvania, 17101, United States
UPMC Presbyterian
RECRUITING

Pittsburgh, Pennsylvania, 15213, United States
University Hospitals Cleveland Medical Center
RECRUITING

Cleveland, Ohio, 44106, United States
University of Alabama Birmingham (UAB) Hospital
RECRUITING

Birmingham, Alabama, 35233, United States
University of Kansas Medical Center
RECRUITING

Kansas City, Kansas, 66160, United States
University of Maryland Medical Center
COMPLETED

Baltimore, Maryland, 21201, United States
University of Michigan Health System
RECRUITING

Ann Arbor, Michigan, 48109, United States
University of South Florida Health
RECRUITING

Tampa, Florida, 33606, United States
University of Virginia Medical Center
RECRUITING

Charlottesville, Virginia, 22908, United States
University of Washington (UW) Medical Center
RECRUITING

Seattle, Washington, 98195, United States
Vanderbilt University Medical Center
RECRUITING

Nashville, Tennessee, 37203, United States
Winchester Medical Center
ACTIVE_NOT_RECRUITING

Winchester, Virginia, 22601, United States
Yale New Haven Hospital
RECRUITING

New Haven, Connecticut, 06510, United States

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