REdo tranScatheter Aortic Valve Replacement for Transcatheter aOrtic Valve failuRE

Last updated: May 30, 2025
Sponsor: Medtronic Cardiovascular
Overall Status: Active - Recruiting

Phase

N/A

Condition

Heart Defect

Congestive Heart Failure

Treatment

Edwards TAV

Medtronic TAV

Clinical Study ID

NCT06777368
MDT23040EVR015
  • Ages 18-105
  • All Genders

Study Summary

The purpose of this study is to generate clinical evidence on valve safety and performance in subjects treated by redo Transcatheter Aortic Valve Replacement (TAVR).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • BVF of a TAV (either Medtronic or Edwards) requiring redo TAVR

Exclusion

Exclusion Criteria:

  • BVF due solely to paravalvular regurgitation

  • Active endocarditis

  • Untreated acute valve thrombosis

  • Life-expectancy less than 1-year

  • Subject is less than legal age of consent, legally incompetent, or otherwisevulnerable

  • Participating in another study that may influence the outcome of this study

Study Design

Total Participants: 225
Treatment Group(s): 2
Primary Treatment: Edwards TAV
Phase:
Study Start date:
February 06, 2025
Estimated Completion Date:
July 31, 2033

Study Description

Primary Objectives:

  • To determine the acute and long-term outcomes of redo TAVR for the treatment of BVF affecting TAVs

  • To determine the factors which are associated with the acute and long-term outcomes of redo TAVR

Connect with a study center

  • Abrazo Arizona Heart Hospital

    Phoenix, Arizona 85016
    United States

    Active - Recruiting

  • Kaiser Permanente Los Angeles Medical Center

    Los Angeles, California 90027
    United States

    Active - Recruiting

  • Sutter Heatlh

    Sacramento, California 95816
    United States

    Active - Recruiting

  • Los Robles Regional Medical Center

    Thousand Oaks, California 91360
    United States

    Active - Recruiting

  • Hartford Hospital

    Hartford, Connecticut 06106
    United States

    Active - Recruiting

  • Yale New Haven Hospital

    New Haven, Connecticut 05610
    United States

    Active - Recruiting

  • MedStar Washington Medical Center

    Washington, District of Columbia 20010
    United States

    Active - Recruiting

  • Morton Plant Hospital

    Clearwater, Florida 33756
    United States

    Active - Recruiting

  • HealthPark Medical Center, Lee Memorial Health

    Fort Myers, Florida 33908
    United States

    Active - Recruiting

  • Orlando Health/Orlando Regional Medical Center

    Orlando, Florida 32806
    United States

    Active - Recruiting

  • MercyOne Iowa Heart Center

    Des Moines, Iowa 50314
    United States

    Active - Recruiting

  • Maine Medical Center

    Portland, Maine 04102
    United States

    Active - Recruiting

  • Medstar Union Memorial Hospital

    Baltimore, Maryland 21218
    United States

    Active - Recruiting

  • Brigham and Women's Hospital

    Boston, Massachusetts 02135
    United States

    Active - Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • University of Michigan Health

    Ann Arbor, Michigan 48109
    United States

    Active - Recruiting

  • Henry Ford Hospital

    Detroit, Michigan 48202
    United States

    Active - Recruiting

  • Abbott Northwestern/Minneapolis Heart

    Minneapolis, Minnesota 55407
    United States

    Active - Recruiting

  • Providence Saint Patrick Hospital

    Missoula, Montana 59802
    United States

    Active - Recruiting

  • The Valley Hospital

    Paramus, New Jersey 07652
    United States

    Active - Recruiting

  • Montefiore Medical Center

    Bronx, New York 10467
    United States

    Active - Recruiting

  • Buffalo General Medical Center

    Buffalo, New York 14203
    United States

    Active - Recruiting

  • Northwell Health

    Manhasset, New York 11030
    United States

    Active - Recruiting

  • Saint Francis Hospital

    Roslyn, New York 11576
    United States

    Active - Recruiting

  • Astrium Health Wake Forest Baptist Medical Center

    Winston-Salem, North Carolina 27157
    United States

    Active - Recruiting

  • The Christ Hospital

    Cincinnati, Ohio 45219
    United States

    Active - Recruiting

  • University Hospitals of Cleveland Medical Center

    Cleveland, Ohio 44106
    United States

    Active - Recruiting

  • Lehigh Valley Hospital

    Allentown, Pennsylvania 18103
    United States

    Active - Recruiting

  • UPMC Pinnacle

    Mechanicsburg, Pennsylvania 17050
    United States

    Active - Recruiting

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania 16212
    United States

    Active - Recruiting

  • Lankenau Medical Center

    Wynnewood, Pennsylvania 19096
    United States

    Active - Recruiting

  • Heart Hospital of Austin

    Austin, Texas 78705
    United States

    Active - Recruiting

  • Houston Methodist Hospital

    Houston, Texas 77030
    United States

    Active - Recruiting

  • University of Texas Health Science Center at Houston

    Houston, Texas 77479
    United States

    Active - Recruiting

  • Methodist Hospital

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • University of Vermont Medical Center

    Burlington, Vermont 05401
    United States

    Active - Recruiting

  • University of Virginia Medical Center

    Charlottesville, Virginia 22908
    United States

    Active - Recruiting

  • Inova Fairfax Hospital

    Falls Church, Virginia 22042
    United States

    Active - Recruiting

  • Sentara Norfolk General Hospital

    Norfolk, Virginia 23507
    United States

    Active - Recruiting

  • Providence Heart Institute (Providence Sacred Heart)

    Spokane, Washington 99204
    United States

    Active - Recruiting

  • Aurora St. Lukes Medical Center

    Milwaukee, Wisconsin 53215
    United States

    Active - Recruiting

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