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NCT06777368Recruiting

REdo tranScatheter Aortic Valve Replacement for Transcatheter aOrtic Valve failuRE

Medtronic Cardiovascular

Start Date

2/6/2025

Completion Date

11/1/2027

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).

Detailed 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

Eligibility Criteria

Age Range: 18 years to 105 years

Inclusion Criteria: * BVF of a TAV (either Medtronic or Edwards) requiring redo TAVR 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 otherwise vulnerable * Participating in another study that may influence the outcome of this study

Interventions

DEVICE

Medtronic TAV

DEVICE

Edwards TAV

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Conditions

Aortic Stenosis

Locations

University of Alabama at Birmingham

Birmingham, Alabama 35233

United States

Abrazo Arizona Heart Hospital

Phoenix, Arizona 85016

United States

Tucson Medical Center

Tucson, Arizona 85712

United States

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California 90027

United States

Sutter Heatlh

Sacramento, California 95816

United States

Kaiser Permanente Northern California

Sacramento, California 95825

United States

Stanford Hospital & Clinics

Stanford, California 94305

United States

Los Robles Regional Medical Center

Thousand Oaks, California 91360

United States

Medical Center of the Rockies

Loveland, Colorado 80538

United States

Hartford Hospital

Hartford, Connecticut 06106

United States

Yale New Haven Hospital

New Haven, Connecticut 05610

United States

MedStar Washington Medical Center

Washington D.C., District of Columbia 20010

United States

Morton Plant Hospital

Clearwater, Florida 33756

United States

HealthPark Medical Center, Lee Memorial Health

Fort Myers, Florida 33908

United States

Orlando Health/Orlando Regional Medical Center

Orlando, Florida 32806

United States

Tampa General/USF

Tampa, Florida 33606

United States

Parkview Health

Fort Wayne, Indiana 46845

United States

Saint Vincent Heart Center of Indiana

Indianapolis, Indiana 46290

United States

MercyOne Iowa Heart Center

Des Moines, Iowa 50314

United States

University of Iowa Hospitals and Clinics

Iowa City, Iowa 52242

United States

The University of Kansas

Kansas City, Kansas 66103

United States

Ascension Via Christi St. Francis

Wichita, Kansas 67214

United States

Maine Medical Center

Portland, Maine 04102

United States

Medstar Union Memorial Hospital

Baltimore, Maryland 21218

United States

The Johns Hopkins Hospital

Baltimore, Maryland 21287

United States

Massachusetts General Hospital

Boston, Massachusetts 02114

United States

Brigham and Women's Hospital

Boston, Massachusetts 02135

United States

University of Michigan Health

Ann Arbor, Michigan 48109

United States

Henry Ford Hospital

Detroit, Michigan 48202

United States

Corewell Health (Spectrum)

Grand Rapids, Michigan 49503

United States

Abbott Northwestern/Minneapolis Heart

Minneapolis, Minnesota 55407

United States

Mayo Clinic

Rochester, Minnesota 55905

United States

CentraCare Heart and Vascular Center

Saint Cloud, Minnesota 56303

United States

St. Luke's Hospital of Kansas City

Kansas City, Missouri 64111

United States

Providence Saint Patrick Hospital

Missoula, Montana 59802

United States

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire 03756

United States

Catholic Medical Center

Manchester, New Hampshire 03102

United States

Jersey Shore University Medical Center

Neptune City, New Jersey 07753

United States

The Valley Hospital

Paramus, New Jersey 07652

United States

Buffalo General Medical Center

Buffalo, New York 14203

United States

Northwell Health

Manhasset, New York 11030

United States

NYU Langone Medical Center

New York, New York 10016

United States

Mount Sinai Hospital

New York, New York 10029

United States

Saint Francis Hospital

Roslyn, New York 11576

United States

Montefiore Medical Center

The Bronx, New York 10467

United States

Astrium Health Wake Forest Baptist Medical Center

Winston-Salem, North Carolina 27157

United States

The Christ Hospital

Cincinnati, Ohio 45219

United States

University Hospitals of Cleveland Medical Center

Cleveland, Ohio 44106

United States

OhioHealth Riverside Methodist Hospital

Columbus, Ohio 43214

United States

Oklahoma Heart Hospital

Oklahoma City, Oklahoma 73120

United States

Providence Saint Vincent Medical Center

Portland, Oregon 97225

United States

Lehigh Valley Hospital

Allentown, Pennsylvania 18103

United States

UPMC Pinnacle

Mechanicsburg, Pennsylvania 17050

United States

Allegheny General Hospital

Pittsburgh, Pennsylvania 15212

United States

UPMC Presbyterian

Pittsburgh, Pennsylvania 15213

United States

Lankenau Medical Center

Wynnewood, Pennsylvania 19096

United States

TriStar Centennial Medical Center

Nashville, Tennessee 37203

United States

St. Thomas West Hospital

Nashville, Tennessee 37205

United States

Ascension Seton Medical Center Austin

Austin, Texas 78705

United States

Heart Hospital of Austin

Austin, Texas 78705

United States

Baylor Saint Luke's (The Texas Heart Institute)

Houston, Texas 77030

United States

Houston Methodist Hospital

Houston, Texas 77030

United States

University of Texas Health Science Center at Houston

Houston, Texas 77479

United States

Methodist Hospital

San Antonio, Texas 78229

United States

University of Vermont Medical Center

Burlington, Vermont 05401

United States

University of Virginia Medical Center

Charlottesville, Virginia 22908

United States

Inova Fairfax Hospital

Falls Church, Virginia 22042

United States

Sentara Norfolk General Hospital

Norfolk, Virginia 23507

United States

Providence Heart Institute (Providence Sacred Heart)

Spokane, Washington 99204

United States

Aurora St. Lukes Medical Center

Milwaukee, Wisconsin 53215

United States

Froedtert Hospital

Milwaukee, Wisconsin 53226

United States