REdo tranScatheter Aortic Valve Replacement for Transcatheter aOrtic Valve failuRE

Last updated: February 10, 2026
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

  • University of Alabama at Birmingham

    Birmingham, Alabama 35233
    United States

    Site Not Available

  • University of Alabama at Birmingham

    Birmingham 4049979, Alabama 4829764 35233
    United States

    Active - Recruiting

  • Abrazo Arizona Heart Hospital

    Phoenix, Arizona 85016
    United States

    Site Not Available

  • Abrazo Arizona Heart Hospital

    Phoenix 5308655, Arizona 5551752 85016
    United States

    Active - Recruiting

  • Tucson Medical Center

    Tucson 5318313, Arizona 5551752 85712
    United States

    Active - Recruiting

  • Kaiser Permanente Los Angeles Medical Center

    Los Angeles, California 90027
    United States

    Site Not Available

  • Sutter Heatlh

    Sacramento, California 95816
    United States

    Site Not Available

  • Los Robles Regional Medical Center

    Thousand Oaks, California 91360
    United States

    Site Not Available

  • Kaiser Permanente Los Angeles Medical Center

    Los Angeles 5368361, California 5332921 90027
    United States

    Active - Recruiting

  • Kaiser Permanente Northern California

    Sacramento 5389489, California 5332921 95825
    United States

    Active - Recruiting

  • Sutter Heatlh

    Sacramento 5389489, California 5332921 95816
    United States

    Active - Recruiting

  • Stanford Hospital & Clinics

    Stanford 5398563, California 5332921 94305
    United States

    Active - Recruiting

  • Los Robles Regional Medical Center

    Thousand Oaks 5402405, California 5332921 91360
    United States

    Active - Recruiting

  • Medical Center of the Rockies

    Loveland 5579368, Colorado 5417618 80538
    United States

    Active - Recruiting

  • Hartford Hospital

    Hartford, Connecticut 06106
    United States

    Site Not Available

  • Yale New Haven Hospital

    New Haven, Connecticut 05610
    United States

    Site Not Available

  • Hartford Hospital

    Hartford 4835797, Connecticut 4831725 06106
    United States

    Active - Recruiting

  • Yale New Haven Hospital

    New Haven 4839366, Connecticut 4831725 05610
    United States

    Active - Recruiting

  • MedStar Washington Medical Center

    Washington, District of Columbia 20010
    United States

    Site Not Available

  • MedStar Washington Medical Center

    Washington D.C. 4140963, District of Columbia 4138106 20010
    United States

    Active - Recruiting

  • Morton Plant Hospital

    Clearwater, Florida 33756
    United States

    Site Not Available

  • HealthPark Medical Center, Lee Memorial Health

    Fort Myers, Florida 33908
    United States

    Site Not Available

  • Orlando Health/Orlando Regional Medical Center

    Orlando, Florida 32806
    United States

    Site Not Available

  • Morton Plant Hospital

    Clearwater 4151316, Florida 4155751 33756
    United States

    Active - Recruiting

  • HealthPark Medical Center, Lee Memorial Health

    Fort Myers 4155995, Florida 4155751 33908
    United States

    Active - Recruiting

  • Orlando Health/Orlando Regional Medical Center

    Orlando 4167147, Florida 4155751 32806
    United States

    Active - Recruiting

  • Tampa General/USF

    Tampa 4174757, Florida 4155751 33606
    United States

    Active - Recruiting

  • Parkview Health

    Fort Wayne 4920423, Indiana 4921868 46845
    United States

    Active - Recruiting

  • Saint Vincent Heart Center of Indiana

    Indianapolis 4259418, Indiana 4921868 46290
    United States

    Active - Recruiting

  • MercyOne Iowa Heart Center

    Des Moines, Iowa 50314
    United States

    Site Not Available

  • MercyOne Iowa Heart Center

    Des Moines 4853828, Iowa 4862182 50314
    United States

    Active - Recruiting

  • University of Iowa Hospitals and Clinics

    Iowa City 4862034, Iowa 4862182 52242
    United States

    Active - Recruiting

  • The University of Kansas

    Kansas City 4273837, Kansas 4273857 66103
    United States

    Active - Recruiting

  • Ascension Via Christi St. Francis

    Wichita 4281730, Kansas 4273857 67214
    United States

    Active - Recruiting

  • Maine Medical Center

    Portland, Maine 04102
    United States

    Active - Recruiting

  • Maine Medical Center

    Portland 4975802, Maine 4971068 04102
    United States

    Active - Recruiting

  • Medstar Union Memorial Hospital

    Baltimore, Maryland 21218
    United States

    Site Not Available

  • Medstar Union Memorial Hospital

    Baltimore 4347778, Maryland 4361885 21218
    United States

    Active - Recruiting

  • The Johns Hopkins Hospital

    Baltimore 4347778, Maryland 4361885 21287
    United States

    Active - Recruiting

  • Brigham and Women's Hospital

    Boston, Massachusetts 02135
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Brigham and Women's Hospital

    Boston 4930956, Massachusetts 6254926 02135
    United States

    Active - Recruiting

  • Massachusetts General Hospital

    Boston 4930956, Massachusetts 6254926 02114
    United States

    Active - Recruiting

  • University of Michigan Health

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • Henry Ford Hospital

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Corewell Health (Spectrum)

    Grand Rapids, Michigan 49503
    United States

    Site Not Available

  • University of Michigan Health

    Ann Arbor 4984247, Michigan 5001836 48109
    United States

    Active - Recruiting

  • Henry Ford Hospital

    Detroit 4990729, Michigan 5001836 48202
    United States

    Active - Recruiting

  • Corewell Health (Spectrum)

    Grand Rapids 4994358, Michigan 5001836 49503
    United States

    Active - Recruiting

  • Abbott Northwestern/Minneapolis Heart

    Minneapolis, Minnesota 55407
    United States

    Site Not Available

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Abbott Northwestern/Minneapolis Heart

    Minneapolis 5037649, Minnesota 5037779 55407
    United States

    Active - Recruiting

  • Mayo Clinic

    Rochester 5043473, Minnesota 5037779 55905
    United States

    Active - Recruiting

  • CentraCare Heart and Vascular Center

    Saint Cloud 5044407, Minnesota 5037779 56303
    United States

    Active - Recruiting

  • St. Luke's Hospital of Kansas City

    Kansas City 4393217, Missouri 4398678 64111
    United States

    Active - Recruiting

  • Providence Saint Patrick Hospital

    Missoula, Montana 59802
    United States

    Site Not Available

  • Providence Saint Patrick Hospital

    Missoula 5666639, Montana 5667009 59802
    United States

    Active - Recruiting

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire 03756
    United States

    Site Not Available

  • Dartmouth-Hitchcock Medical Center

    Lebanon 5088597, New Hampshire 5090174 03756
    United States

    Active - Recruiting

  • Catholic Medical Center

    Manchester 5089178, New Hampshire 5090174 03102
    United States

    Active - Recruiting

  • The Valley Hospital

    Paramus, New Jersey 07652
    United States

    Site Not Available

  • Jersey Shore University Medical Center

    Neptune City 5101687, New Jersey 5101760 07753
    United States

    Active - Recruiting

  • The Valley Hospital

    Paramus 5102387, New Jersey 5101760 07652
    United States

    Active - Recruiting

  • Montefiore Medical Center

    Bronx, New York 10467
    United States

    Site Not Available

  • Buffalo General Medical Center

    Buffalo, New York 14203
    United States

    Site Not Available

  • Northwell Health

    Manhasset, New York 11030
    United States

    Site Not Available

  • Mount Sinai Hospital

    New York, New York 10029
    United States

    Site Not Available

  • Saint Francis Hospital

    Roslyn, New York 11576
    United States

    Site Not Available

  • Buffalo General Medical Center

    Buffalo 5110629, New York 5128638 14203
    United States

    Active - Recruiting

  • Northwell Health

    Manhasset 5125766, New York 5128638 11030
    United States

    Active - Recruiting

  • Mount Sinai Hospital

    New York 5128581, New York 5128638 10029
    United States

    Active - Recruiting

  • NYU Langone Medical Center

    New York 5128581, New York 5128638 10016
    United States

    Active - Recruiting

  • Saint Francis Hospital

    Roslyn 5134415, New York 5128638 11576
    United States

    Active - Recruiting

  • Montefiore Medical Center

    The Bronx 5110266, New York 5128638 10467
    United States

    Active - Recruiting

  • Astrium Health Wake Forest Baptist Medical Center

    Winston-Salem, North Carolina 27157
    United States

    Site Not Available

  • Astrium Health Wake Forest Baptist Medical Center

    Winston-Salem 4499612, North Carolina 4482348 27157
    United States

    Active - Recruiting

  • The Christ Hospital

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • University Hospitals of Cleveland Medical Center

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • The Christ Hospital

    Cincinnati 4508722, Ohio 5165418 45219
    United States

    Active - Recruiting

  • University Hospitals of Cleveland Medical Center

    Cleveland 5150529, Ohio 5165418 44106
    United States

    Active - Recruiting

  • OhioHealth Riverside Methodist Hospital

    Columbus 4509177, Ohio 5165418 43214
    United States

    Active - Recruiting

  • Oklahoma Heart Hospital

    Oklahoma City, Oklahoma 73120
    United States

    Site Not Available

  • Oklahoma Heart Hospital

    Oklahoma City 4544349, Oklahoma 4544379 73120
    United States

    Active - Recruiting

  • Providence Saint Vincent Medical Center

    Portland, Oregon 97225
    United States

    Site Not Available

  • Providence Saint Vincent Medical Center

    Portland 5746545, Oregon 5744337 97225
    United States

    Active - Recruiting

  • Lehigh Valley Hospital

    Allentown, Pennsylvania 18103
    United States

    Site Not Available

  • UPMC Pinnacle

    Mechanicsburg, Pennsylvania 17050
    United States

    Site Not Available

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania 16212
    United States

    Site Not Available

  • Lankenau Medical Center

    Wynnewood, Pennsylvania 19096
    United States

    Site Not Available

  • Lehigh Valley Hospital

    Allentown 5178127, Pennsylvania 6254927 18103
    United States

    Active - Recruiting

  • UPMC Pinnacle

    Mechanicsburg 5200657, Pennsylvania 6254927 17050
    United States

    Active - Recruiting

  • Allegheny General Hospital

    Pittsburgh 5206379, Pennsylvania 6254927 15212
    United States

    Active - Recruiting

  • UPMC Presbyterian

    Pittsburgh 5206379, Pennsylvania 6254927 15213
    United States

    Active - Recruiting

  • Lankenau Medical Center

    Wynnewood 5220230, Pennsylvania 6254927 19096
    United States

    Active - Recruiting

  • St. Thomas West Hospital

    Nashville 4644585, Tennessee 4662168 37205
    United States

    Active - Recruiting

  • TriStar Centennial Medical Center

    Nashville 4644585, Tennessee 4662168 37203
    United States

    Active - Recruiting

  • Heart Hospital of Austin

    Austin, Texas 78705
    United States

    Site Not Available

  • Houston Methodist Hospital

    Houston, Texas 77030
    United States

    Active - Recruiting

  • University of Texas Health Science Center at Houston

    Houston, Texas 77479
    United States

    Site Not Available

  • Methodist Hospital

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Ascension Seton Medical Center Austin

    Austin 4671654, Texas 4736286 78705
    United States

    Active - Recruiting

  • Heart Hospital of Austin

    Austin 4671654, Texas 4736286 78705
    United States

    Active - Recruiting

  • Houston Methodist Hospital

    Houston 4699066, Texas 4736286 77030
    United States

    Active - Recruiting

  • University of Texas Health Science Center at Houston

    Houston 4699066, Texas 4736286 77479
    United States

    Active - Recruiting

  • Methodist Hospital

    San Antonio 4726206, Texas 4736286 78229
    United States

    Active - Recruiting

  • University of Vermont Medical Center

    Burlington, Vermont 05401
    United States

    Site Not Available

  • University of Vermont Medical Center

    Burlington 5234372, Vermont 5242283 05401
    United States

    Active - Recruiting

  • University of Virginia Medical Center

    Charlottesville, Virginia 22908
    United States

    Site Not Available

  • Inova Fairfax Hospital

    Falls Church, Virginia 22042
    United States

    Site Not Available

  • Sentara Norfolk General Hospital

    Norfolk, Virginia 23507
    United States

    Site Not Available

  • University of Virginia Medical Center

    Charlottesville 4752031, Virginia 6254928 22908
    United States

    Active - Recruiting

  • Inova Fairfax Hospital

    Falls Church 4758390, Virginia 6254928 22042
    United States

    Active - Recruiting

  • Sentara Norfolk General Hospital

    Norfolk 4776222, Virginia 6254928 23507
    United States

    Active - Recruiting

  • Providence Heart Institute (Providence Sacred Heart)

    Spokane, Washington 99204
    United States

    Site Not Available

  • Providence Heart Institute (Providence Sacred Heart)

    Spokane 5811696, Washington 5815135 99204
    United States

    Active - Recruiting

  • Aurora St. Lukes Medical Center

    Milwaukee, Wisconsin 53215
    United States

    Site Not Available

  • Aurora St. Lukes Medical Center

    Milwaukee 5263045, Wisconsin 5279468 53215
    United States

    Active - Recruiting

  • Froedtert Hospital

    Milwaukee 5263045, Wisconsin 5279468 53226
    United States

    Active - Recruiting

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