RecruitingNCT06777368

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REdo tranScatheter Aortic Valve Replacement for Transcatheter aOrtic Valve failuRE

Medtronic CardiovascularMultiple US sitesView on ClinicalTrials.gov

AI Description

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).

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Who can join
adult, older adult
Participants
225
Expected completion
2027-11
Funded by
industry

Conditions studied

Aortic Stenosis

What is being tested

  • DEVICE: Edwards TAV
  • DEVICE: Medtronic TAV

What it measures

  • Primary Outcome Measure, 30-day redo TAVR success defined as correct positioning of a single redo prosthetic heart valve into the proper anatomic location, intended performance of the valve (mean gradient \<20mmHg, peak velocity \<3 m/s, Doppler velocity index (DVI) ≥0.25, aortic regurgitation (AR) \< moderate), and freedom from all-cause mortality, coronary obstruction, unplanned coronary revascularization, and surgery or intervention related to the device, Early (30-days)
  • Primary Outcome Measure, a composite endpoint of 1-year freedom from all-cause mortality, all stroke, or any re-hospitalization for valve or redo TAVR procedure-related causes, Late (1-year)

Centers Participating

These centers are participating in this study. Reach out to them directly to learn more.

NexVal Center

Tampa General Hospital

Tampa, FL

Abbott Northwestern Hospital

Minneapolis, MN

Allegheny General Hospital

Pittsburgh, PA

Ascension Saint Thomas Hospital

Nashville, TN

Ascension Seton Medical Center Austin

Austin, TX

Ascension St. Vincent Heart Center

Carmel, IN

Ascension Via Christi (Wichita)

Wichita, KS

Atrium Health Wake Forest Baptist Medical Center

Winston-salem, NC

Aurora St. Luke's Medical Center

Milwaukee, WI

Baylor St. Luke's Medical Center

Houston, TX

Brigham and Women's Hospital

Boston, MA

Catholic Medical Center

Manchester, NH

CentraCare – St. Cloud Hospital

Saint Cloud, MN

Corewell Health Butterworth Hospital

Grand Rapids, MI

Froedtert Hospital

Milwaukee, WI

Hartford Hospital

Hartford, CT

Henry Ford Health (Detroit)

Detroit, MI

Houston Methodist Hospital

Houston, TX

Inova Fairfax Medical Campus

Falls Church, VA

Jersey Shore University Medical Center

Neptune, NJ

Kaleida Health

Buffalo, NY

Lankenau Medical Center

Wynnewood, PA

Lehigh Valley Hospital–Cedar Crest

Allentown, PA

Los Robles Regional Medical Center

Thousand Oaks, CA

MaineHealth Maine Medical Center (Portland)

Portland, ME

Massachusetts General Hospital

Boston, MA

Mayo Clinic (Rochester, Minnesota)

Rochester, MN

MedStar Union Memorial Hospital

Baltimore, MD

MedStar Washington Hospital Center

Washington, DC

Memorial Hermann-Texas Medical Center

Houston, TX

MercyOne Des Moines Medical Center

Des Moines, IA

Methodist Hospital

San Antonio, TX

Montefiore Einstein Hospital (Moses Campus)

Bronx, NY

Morton Plant Hospital (Clearwater)

Clearwater, FL

NYU Langone Health

New York, NY

OhioHealth Riverside Methodist Hospital

Columbus, OH

Oklahoma Heart Hospital (Oklahoma City)

Oklahoma City, OK

Orlando Health

Orlando, FL

Parkview Regional Medical Center

Fort Wayne, IN

Penn State Health Holy Spirit Medical Center

Camp Hill, PA

Providence Sacred Heart Medical Center & Children's Hospital

Spokane, WA

Providence St. Patrick Hospital

Missoula, MT

Providence St. Vincent Medical Center

Portland, OR

Saint Luke’s Hospital of Kansas City

Kansas City, MO

Sandra Atlas Bass Heart Hospital at North Shore University Hospital

Manhasset, NY

Sentara Norfolk General Hospital

Norfolk, VA

St. Francis Hospital & Heart Center

Roslyn, NY

Stanford Health Care

Stanford, CA

Sutter Medical Center, Sacramento

Sacramento, CA

The Christ Hospital

Cincinnati, OH

The Johns Hopkins Hospital

Baltimore, MD

The Mount Sinai Hospital

New York, NY

The University of Kansas Health System

Kansas City, KS

The University of Vermont Medical Center

Burlington, VT

The Valley Hospital

Paramus, NJ

TriStar Centennial Medical Center

Nashville, TN

Tucson Medical Center

Tucson, AZ

UAB Hospital

Birmingham, AL

UCHealth Medical Center of the Rockies

Loveland, CO

University Hospitals Cleveland Medical Center

Cleveland, OH

University Medical Center

Charlottesville, VA

University of Iowa Health Care

Iowa City, IA

University of Michigan Health System

Ann Arbor, MI

UPMC Presbyterian Shadyside

Pittsburgh, PA

Yale New Haven Hospital

New Haven, CT

Data Sources and Methodology

Registry entry updated 2026-05-28

Deciding whether to join a study is your choice, and you can ask a study team questions before you decide anything.

If you would rather we did it with you, call us on (656) 206-4686.