REdo tranScatheter Aortic Valve Replacement for Transcatheter aOrtic Valve failuRE

Recruiting now

Conditions studied: Aortic Stenosis

In brief

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).

Key facts

Study ID

NCT06777368

Run by

Medtronic Cardiovascular

People needed

225

Starts

2025-02-06

Expected to finish

2027-11-01

Last updated by the study team

2026-05-28

Who can join

Age: 18 and older, up to 105. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Abrazo Arizona Heart Hospital — Phoenix, Arizona, United States (enrolling)
• Tucson Medical Center — Tucson, Arizona, United States (enrolling)
• Kaiser Permanente Los Angeles Medical Center — Los Angeles, California, United States (enrolling)
• Sutter Heatlh — Sacramento, California, United States (enrolling)
• Kaiser Permanente Northern California — Sacramento, California, United States (enrolling)
• Stanford Hospital & Clinics — Stanford, California, United States (enrolling)
• Los Robles Regional Medical Center — Thousand Oaks, California, United States (enrolling)
• Medical Center of the Rockies — Loveland, Colorado, United States (enrolling)
• Hartford Hospital — Hartford, Connecticut, United States (enrolling)
• Yale New Haven Hospital — New Haven, Connecticut, United States (enrolling)
• MedStar Washington Medical Center — Washington D.C., District of Columbia, United States (enrolling)
• Morton Plant Hospital — Clearwater, Florida, United States (enrolling)
• HealthPark Medical Center, Lee Memorial Health — Fort Myers, Florida, United States (enrolling)
• Orlando Health/Orlando Regional Medical Center — Orlando, Florida, United States (enrolling)
• Tampa General/USF — Tampa, Florida, United States (enrolling)
• Parkview Health — Fort Wayne, Indiana, United States (enrolling)
• Saint Vincent Heart Center of Indiana — Indianapolis, Indiana, United States (enrolling)
• MercyOne Iowa Heart Center — Des Moines, Iowa, United States (enrolling)
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States (enrolling)
• The University of Kansas — Kansas City, Kansas, United States (enrolling)
• Ascension Via Christi St. Francis — Wichita, Kansas, United States (enrolling)
• Maine Medical Center — Portland, Maine, United States (enrolling)
• Medstar Union Memorial Hospital — Baltimore, Maryland, United States (enrolling)
• The Johns Hopkins Hospital — Baltimore, Maryland, United States (enrolling)
• University of Alabama at Birmingham — Birmingham, Alabama, United States (enrolling)

Full record on ClinicalTrials.gov

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