Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation.

Last updated: April 7, 2025
Sponsor: Medtronic Cardiovascular
Overall Status: Active - Recruiting

Phase

N/A

Condition

Mitral Valve Regurgitation

Treatment

Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR)

Clinical Study ID

NCT03242642
MDT17022TMV001
  • Ages > 18
  • All Genders

Study Summary

Multi-center, global, prospective, non-randomized, interventional, pre-market trial. All subjects enrolled with receive the study device.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Moderate to severe or severe symptomatic mitral regurgitation

  • Local site multidisciplinary heart team experienced in mitral valve therapies agreesthat the subject is unsuitable for treatment with approved transcatheter repair orconventional mitral valve intervention

Exclusion

Exclusion Criteria:

  • prior transcatheter mitral valve procedure with device currently implanted

  • anatomic contraindications

  • prohibitive mitral annular calcification

  • left ventricular ejection fraction <25%

  • need for emergent or urgent surgery

  • hemodynamic instability

Study Design

Total Participants: 1056
Treatment Group(s): 1
Primary Treatment: Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR)
Phase:
Study Start date:
October 23, 2017
Estimated Completion Date:
September 30, 2036

Connect with a study center

  • Royal Columbian Hospital

    New Westminster, British Columbia V3L 3W7
    Canada

    Active - Recruiting

  • St. Paul's Hospital

    Vancouver, British Columbia V6Z 1Y6
    Canada

    Active - Recruiting

  • St. Michael's Hospital

    Toronto, Ontario M5B 1W8
    Canada

    Active - Recruiting

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario M4N 3M5
    Canada

    Active - Recruiting

  • Glen Royal Victoria

    Montreal, Quebec H4A 3J1
    Canada

    Active - Recruiting

  • Glen Royal Victoria Hospital

    Montreal, Quebec H4A 3J1
    Canada

    Active - Recruiting

  • Montreal Heart Insitute

    Montreal, Quebec H1T 1C8
    Canada

    Active - Recruiting

  • Rigshospitalet

    Copenhagen, 2100
    Denmark

    Site Not Available

  • University of Alabama Birmingham (UAB)

    Birmingham, Alabama 35233
    United States

    Active - Recruiting

  • Abrazo Heart Hospital

    Phoenix, Arizona 85018
    United States

    Active - Recruiting

  • Scripps Memorial Hospital

    La Jolla, California 92037
    United States

    Active - Recruiting

  • Cedars Sinai Medical Center

    Los Angeles, California 90048
    United States

    Active - Recruiting

  • Kaiser Permanente Los Angeles Medical Center

    Los Angeles, California 90027
    United States

    Active - Recruiting

  • Keck Hospital of the University of Southern California

    Los Angeles, California 90033
    United States

    Active - Recruiting

  • PIH Health Good Samaritan Hospital

    Los Angeles, California 90017
    United States

    Active - Recruiting

  • El Camino

    Mountain View, California 94040
    United States

    Active - Recruiting

  • Kaiser Permanente San Francisco Medical Center

    San Francisco, California 94118-3100
    United States

    Active - Recruiting

  • Stanford Hospital and Clinics

    Stanford, California 94305
    United States

    Active - Recruiting

  • Los Robles Regional Medical Center

    Thousand Oaks, California 91360-1847
    United States

    Active - Recruiting

  • Hartford Hospital

    Hartford, Connecticut 06102
    United States

    Active - Recruiting

  • Yale New Haven Hospital

    New Haven, Connecticut 06510
    United States

    Active - Recruiting

  • MedStar Washington Hospital Center

    Washington, District of Columbia 20010
    United States

    Active - Recruiting

  • JFK Medical Center

    Atlantis, Florida 33462
    United States

    Active - Recruiting

  • Morton Plant

    Clearwater, Florida 33756
    United States

    Active - Recruiting

  • HealthPark Medical Center

    Fort Myers, Florida 33908
    United States

    Active - Recruiting

  • North Florida Regional Medical Center

    Gainesville, Florida 32605
    United States

    Active - Recruiting

  • Baptist Medical Center Jacksonville

    Jacksonville, Florida 32207
    United States

    Active - Recruiting

  • University of South Florida

    Tampa, Florida 33606
    United States

    Active - Recruiting

  • Emory University

    Atlanta, Georgia 30308
    United States

    Active - Recruiting

  • Piedmont Atlanta Hospital

    Atlanta, Georgia 30309
    United States

    Active - Recruiting

  • Northwestern Memorial Hospital

    Chicago, Illinois 60611
    United States

    Active - Recruiting

  • Rush University Medical Center

    Chicago, Illinois 60612
    United States

    Active - Recruiting

  • Mercy Medical Center

    Des Moines, Iowa 50314
    United States

    Active - Recruiting

  • The University of Kansas Hospital

    Kansas City, Kansas 66160
    United States

    Active - Recruiting

  • The Johns Hopkins Hospital

    Baltimore, Maryland 21287
    United States

    Active - Recruiting

  • University of Maryland Medical Center

    Baltimore, Maryland 21201
    United States

    Site Not Available

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • Brigham and Women's Hospital

    Boston, Massachusetts 02115
    United States

    Active - Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • University of Michigan Health System

    Ann Arbor, Michigan 48109
    United States

    Active - Recruiting

  • Ascension St. John Hospital

    Detroit, Michigan 48236
    United States

    Active - Recruiting

  • Henry Ford Saint John Hospital

    Detroit, Michigan 48236
    United States

    Active - Recruiting

  • Corewell Health

    Grand Rapids, Michigan 49503
    United States

    Active - Recruiting

  • Spectrum Health Hospital

    Grand Rapids, Michigan 49503
    United States

    Active - Recruiting

  • Abbott Northwestern Hospital

    Minneapolis, Minnesota 55407
    United States

    Active - Recruiting

  • M Health Fairview University of Minnesota Medical Center - East Bank

    Minneapolis, Minnesota 55455
    United States

    Active - Recruiting

  • University of Minnesota Medical Center Fairview

    Minneapolis, Minnesota 55455
    United States

    Active - Recruiting

  • Barnes-Jewish Hospital

    Saint Louis, Missouri 63110-1003
    United States

    Active - Recruiting

  • Providence St Patrick

    Missoula, Montana 59802-4008
    United States

    Active - Recruiting

  • AHS (Atlantic Health System)

    Morristown, New Jersey 07960
    United States

    Active - Recruiting

  • Morristown Medical Center

    Morristown, New Jersey 07960
    United States

    Active - Recruiting

  • Morristown Memorial Hospital

    Morristown, New Jersey 07960
    United States

    Active - Recruiting

  • Jersey Shore University Medical Center

    Neptune, New Jersey 07753
    United States

    Active - Recruiting

  • North Shore University Hospital

    Manhasset, New York 11030
    United States

    Active - Recruiting

  • NYU Langone Hospital - Long Island

    Mineola, New York 11501
    United States

    Active - Recruiting

  • Columbia University Medical Center/NYPH

    New York, New York 10032
    United States

    Active - Recruiting

  • Montefiore Medical Center

    New York, New York 10467-2401
    United States

    Active - Recruiting

  • NYU Langone Medical Center

    New York, New York 10016
    United States

    Active - Recruiting

  • New York-Presbyterian Hospital Columbia University Medical Center

    New York, New York 10032
    United States

    Active - Recruiting

  • The Mount Sinai Hospital

    New York, New York 10029
    United States

    Active - Recruiting

  • Saint Francis Hospital

    Roslyn, New York 11576
    United States

    Active - Recruiting

  • Duke University Medical Center

    Durham, North Carolina 27710
    United States

    Active - Recruiting

  • The Christ Hospital

    Cincinnati, Ohio 45219-2906
    United States

    Active - Recruiting

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio 44106
    United States

    Active - Recruiting

  • OhioHealth Riverside Methodist Hospital

    Columbus, Ohio 43214
    United States

    Active - Recruiting

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio 43210
    United States

    Active - Recruiting

  • INTEGRIS Baptist Medical Center

    Oklahoma City, Oklahoma 73112
    United States

    Active - Recruiting

  • Oregon Health and Science University

    Portland, Oregon 97239
    United States

    Active - Recruiting

  • Providence Saint Vincent Medical Center

    Portland, Oregon 97225
    United States

    Active - Recruiting

  • UPMC Pinnacle Harrisburg Campus

    Harrisburg, Pennsylvania 17101
    United States

    Active - Recruiting

  • University of Pittsburgh Medical Center UPMC Presbyterian

    Pittsburgh, Pennsylvania 15213
    United States

    Active - Recruiting

  • Lankenau Medical Center

    Wynnewood, Pennsylvania 19096
    United States

    Active - Recruiting

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Heart Hospital of Austin

    Austin, Texas 78756
    United States

    Active - Recruiting

  • Baylor Jack and Jane Hamilton Heart and Vascular Hospital

    Dallas, Texas 75246
    United States

    Site Not Available

  • Texas Health Presbyterian Hospital Dallas

    Dallas, Texas 75231
    United States

    Active - Recruiting

  • CHI Saint Luke's Health-Baylor Saint Luke's Medical Center

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Houston Methodist Hospital

    Houston, Texas 77030
    United States

    Active - Recruiting

  • The University of Texas Health Science Center at Houston

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Baylor Scott & White Health (The Heart Hospital Baylor Plano)

    Plano, Texas 75093
    United States

    Active - Recruiting

  • The Heart Hospital Baylor Plano

    Plano, Texas 75093
    United States

    Active - Recruiting

  • Methodist Hospital

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • The University of Vermont Medical Center

    Burlington, Vermont 05401-1473
    United States

    Active - Recruiting

  • University of Virginia Medical Center

    Charlottesville, Virginia 22908
    United States

    Active - Recruiting

  • Inova Fairfax Hospital

    Fairfax, Virginia 22042
    United States

    Active - Recruiting

  • Sentara Norfolk General Hospital

    Norfolk, Virginia 23507-1904
    United States

    Active - Recruiting

  • Saint Mary's Hospital/Bon Secours

    Richmond, Virginia 23226
    United States

    Site Not Available

  • Carilion Roanoke Memorial Hospital

    Roanoke, Virginia 24014
    United States

    Active - Recruiting

  • Winchester Medical Center

    Winchester, Virginia 22601
    United States

    Site Not Available

  • The Swedish Medical Center Cherry Hill

    Seattle, Washington 98122
    United States

    Site Not Available

  • University of Washington

    Seattle, Washington 98195
    United States

    Active - Recruiting

  • Providence Sacred Heart Medical Center & Children's Hospital

    Spokane, Washington 99204
    United States

    Active - Recruiting

  • Aurora St. Luke's Medical Center

    Milwaukee, Wisconsin 53215
    United States

    Active - Recruiting

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