RecruitingNCT06777368

REdo tranScatheter Aortic Valve Replacement for Transcatheter aOrtic Valve failuRE


Sponsor

Medtronic Cardiovascular

Enrollment

225 participants

Start Date

Feb 6, 2025

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 YearsMax Age: 105 Years

Inclusion Criteria1

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

Exclusion Criteria6

  • 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

DEVICEMedtronic TAV

Medtronic TAV where commercially available

DEVICEEdwards TAV

Edwards TAV where commercially available.


Locations(70)

Hartford Hospital

Hartford, Connecticut, United States

University of Alabama at Birmingham

Birmingham, Alabama, United States

Abrazo Arizona Heart Hospital

Phoenix, Arizona, United States

Tucson Medical Center

Tucson, Arizona, United States

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, United States

Sutter Heatlh

Sacramento, California, United States

Kaiser Permanente Northern California

Sacramento, California, United States

Stanford Hospital & Clinics

Stanford, California, United States

Los Robles Regional Medical Center

Thousand Oaks, California, United States

Medical Center of the Rockies

Loveland, Colorado, United States

Yale New Haven Hospital

New Haven, Connecticut, United States

MedStar Washington Medical Center

Washington D.C., District of Columbia, United States

Morton Plant Hospital

Clearwater, Florida, United States

HealthPark Medical Center, Lee Memorial Health

Fort Myers, Florida, United States

Orlando Health/Orlando Regional Medical Center

Orlando, Florida, United States

Tampa General/USF

Tampa, Florida, United States

Parkview Health

Fort Wayne, Indiana, United States

Saint Vincent Heart Center of Indiana

Indianapolis, Indiana, United States

MercyOne Iowa Heart Center

Des Moines, Iowa, United States

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

The University of Kansas

Kansas City, Kansas, United States

Ascension Via Christi St. Francis

Wichita, Kansas, United States

Maine Medical Center

Portland, Maine, United States

Medstar Union Memorial Hospital

Baltimore, Maryland, United States

The Johns Hopkins Hospital

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

University of Michigan Health

Ann Arbor, Michigan, United States

Henry Ford Hospital

Detroit, Michigan, United States

Corewell Health (Spectrum)

Grand Rapids, Michigan, United States

Abbott Northwestern/Minneapolis Heart

Minneapolis, Minnesota, United States

Mayo Clinic

Rochester, Minnesota, United States

CentraCare Heart and Vascular Center

Saint Cloud, Minnesota, United States

St. Luke's Hospital of Kansas City

Kansas City, Missouri, United States

Providence Saint Patrick Hospital

Missoula, Montana, United States

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Catholic Medical Center

Manchester, New Hampshire, United States

Jersey Shore University Medical Center

Neptune City, New Jersey, United States

The Valley Hospital

Paramus, New Jersey, United States

Buffalo General Medical Center

Buffalo, New York, United States

Northwell Health

Manhasset, New York, United States

NYU Langone Medical Center

New York, New York, United States

Mount Sinai Hospital

New York, New York, United States

Saint Francis Hospital

Roslyn, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

Astrium Health Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, United States

The Christ Hospital

Cincinnati, Ohio, United States

University Hospitals of Cleveland Medical Center

Cleveland, Ohio, United States

OhioHealth Riverside Methodist Hospital

Columbus, Ohio, United States

Oklahoma Heart Hospital

Oklahoma City, Oklahoma, United States

Providence Saint Vincent Medical Center

Portland, Oregon, United States

Lehigh Valley Hospital

Allentown, Pennsylvania, United States

UPMC Pinnacle

Mechanicsburg, Pennsylvania, United States

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

UPMC Presbyterian

Pittsburgh, Pennsylvania, United States

Lankenau Medical Center

Wynnewood, Pennsylvania, United States

TriStar Centennial Medical Center

Nashville, Tennessee, United States

St. Thomas West Hospital

Nashville, Tennessee, United States

Ascension Seton Medical Center Austin

Austin, Texas, United States

Heart Hospital of Austin

Austin, Texas, United States

Houston Methodist Hospital

Houston, Texas, United States

University of Texas Health Science Center at Houston

Houston, Texas, United States

Methodist Hospital

San Antonio, Texas, United States

University of Vermont Medical Center

Burlington, Vermont, United States

University of Virginia Medical Center

Charlottesville, Virginia, United States

Inova Fairfax Hospital

Falls Church, Virginia, United States

Sentara Norfolk General Hospital

Norfolk, Virginia, United States

Providence Heart Institute (Providence Sacred Heart)

Spokane, Washington, United States

Aurora St. Lukes Medical Center

Milwaukee, Wisconsin, United States

Froedtert Hospital

Milwaukee, Wisconsin, United States

View Full Details on ClinicalTrials.gov

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NCT06777368


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