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Second chance: can a new valve fix a failing TAVR without open surgery?

NCT ID NCT06777368

Disease control Sponsor: Medtronic Cardiovascular Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is for people whose first TAVR heart valve is failing. Doctors will place a new TAVR valve inside the old one. The goal is to see if this 'redo' procedure is safe and works well. About 225 people will take part, and researchers will check how the valve performs at 30 days and one year.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Medtronic TAV or Edwards TAV device
What this could lead to
If successful, this could provide a proven way to replace a failing TAVR valve without open-heart surgery, offering a safer option for patients.
What could go wrong
This is a relatively small, early-stage study (225 people) focused on safety and device performance. The procedure carries risks like stroke, heart damage, or need for further surgery.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 225 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2025

Expected to finish

Nov 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The study population includes patients with symptomatic heart disease due to BVF affecting TAVs and requiring redo TAVR.

Ages

18 to 105 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Get notified about this study

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Conditions

The condition(s) this trial relates to.

aortic valve stenosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Aortic stenosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    71 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Abbott Northwestern/Minneapolis Heart

    RECRUITING

    Minneapolis, Minnesota, 55407, United States

  • Abrazo Arizona Heart Hospital

    RECRUITING

    Phoenix, Arizona, 85016, United States

  • Allegheny General Hospital

    RECRUITING

    Pittsburgh, Pennsylvania, 15212, United States

  • Ascension Seton Medical Center Austin

    RECRUITING

    Austin, Texas, 78705, United States

  • Ascension Via Christi St. Francis

    RECRUITING

    Wichita, Kansas, 67214, United States

  • Astrium Health Wake Forest Baptist Medical Center

    RECRUITING

    Winston-Salem, North Carolina, 27157, United States

  • Aurora St. Lukes Medical Center

    RECRUITING

    Milwaukee, Wisconsin, 53215, United States

  • Baylor Saint Luke's (The Texas Heart Institute)

    RECRUITING

    Houston, Texas, 77030, United States

  • Brigham and Women's Hospital

    RECRUITING

    Boston, Massachusetts, 02135, United States

  • Buffalo General Medical Center

    RECRUITING

    Buffalo, New York, 14203, United States

  • Catholic Medical Center

    RECRUITING

    Manchester, New Hampshire, 03102, United States

  • CentraCare Heart and Vascular Center

    RECRUITING

    Saint Cloud, Minnesota, 56303, United States

  • Corewell Health (Spectrum)

    RECRUITING

    Grand Rapids, Michigan, 49503, United States

  • Dartmouth-Hitchcock Medical Center

    RECRUITING

    Lebanon, New Hampshire, 03756, United States

  • Froedtert Hospital

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • Hartford Hospital

    RECRUITING

    Hartford, Connecticut, 06106, United States

  • HealthPark Medical Center, Lee Memorial Health

    RECRUITING

    Fort Myers, Florida, 33908, United States

  • Heart Hospital of Austin

    RECRUITING

    Austin, Texas, 78705, United States

  • Henry Ford Hospital

    RECRUITING

    Detroit, Michigan, 48202, United States

  • Houston Methodist Hospital

    RECRUITING

    Houston, Texas, 77030, United States

  • Inova Fairfax Hospital

    RECRUITING

    Falls Church, Virginia, 22042, United States

  • Jersey Shore University Medical Center

    RECRUITING

    Neptune City, New Jersey, 07753, United States

  • Kaiser Permanente Los Angeles Medical Center

    RECRUITING

    Los Angeles, California, 90027, United States

  • Kaiser Permanente Northern California

    RECRUITING

    Sacramento, California, 95825, United States

  • Lankenau Medical Center

    RECRUITING

    Wynnewood, Pennsylvania, 19096, United States

  • Lehigh Valley Hospital

    RECRUITING

    Allentown, Pennsylvania, 18103, United States

  • Los Robles Regional Medical Center

    RECRUITING

    Thousand Oaks, California, 91360, United States

  • Maine Medical Center

    RECRUITING

    Portland, Maine, 04102, United States

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • MedStar Washington Medical Center

    RECRUITING

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

  • Medical Center of the Rockies

    RECRUITING

    Loveland, Colorado, 80538, United States

  • Medstar Union Memorial Hospital

    RECRUITING

    Baltimore, Maryland, 21218, United States

  • MercyOne Iowa Heart Center

    RECRUITING

    Des Moines, Iowa, 50314, United States

  • Methodist Hospital

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Montefiore Medical Center

    RECRUITING

    The Bronx, New York, 10467, United States

  • Morton Plant Hospital

    RECRUITING

    Clearwater, Florida, 33756, United States

  • Mount Sinai Hospital

    RECRUITING

    New York, New York, 10029, United States

  • NYU Langone Medical Center

    RECRUITING

    New York, New York, 10016, United States

  • Northwell Health

    RECRUITING

    Manhasset, New York, 11030, United States

  • OhioHealth Riverside Methodist Hospital

    RECRUITING

    Columbus, Ohio, 43214, United States

  • Oklahoma Heart Hospital

    RECRUITING

    Oklahoma City, Oklahoma, 73120, United States

  • Orlando Health/Orlando Regional Medical Center

    RECRUITING

    Orlando, Florida, 32806, United States

  • Parkview Health

    RECRUITING

    Fort Wayne, Indiana, 46845, United States

  • Providence Heart Institute (Providence Sacred Heart)

    RECRUITING

    Spokane, Washington, 99204, United States

  • Providence Saint Patrick Hospital

    RECRUITING

    Missoula, Montana, 59802, United States

  • Providence Saint Vincent Medical Center

    RECRUITING

    Portland, Oregon, 97225, United States

  • Saint Francis Hospital

    RECRUITING

    Roslyn, New York, 11576, United States

  • Saint Vincent Heart Center of Indiana

    RECRUITING

    Indianapolis, Indiana, 46290, United States

  • Sentara Norfolk General Hospital

    RECRUITING

    Norfolk, Virginia, 23507, United States

  • St. Luke's Hospital of Kansas City

    RECRUITING

    Kansas City, Missouri, 64111, United States

  • St. Thomas West Hospital

    RECRUITING

    Nashville, Tennessee, 37205, United States

  • Stanford Hospital & Clinics

    RECRUITING

    Stanford, California, 94305, United States

  • Sutter Heatlh

    RECRUITING

    Sacramento, California, 95816, United States

  • Tampa General/USF

    RECRUITING

    Tampa, Florida, 33606, United States

  • The Christ Hospital

    RECRUITING

    Cincinnati, Ohio, 45219, United States

  • The Johns Hopkins Hospital

    RECRUITING

    Baltimore, Maryland, 21287, United States

  • The University of Kansas

    RECRUITING

    Kansas City, Kansas, 66103, United States

  • The Valley Hospital

    RECRUITING

    Paramus, New Jersey, 07652, United States

  • TriStar Centennial Medical Center

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Tucson Medical Center

    RECRUITING

    Tucson, Arizona, 85712, United States

  • UPMC Pinnacle

    RECRUITING

    Mechanicsburg, Pennsylvania, 17050, United States

  • UPMC Presbyterian

    RECRUITING

    Pittsburgh, Pennsylvania, 15213, United States

  • University Hospitals of Cleveland Medical Center

    RECRUITING

    Cleveland, Ohio, 44106, United States

  • University of Alabama at Birmingham

    RECRUITING

    Birmingham, Alabama, 35233, United States

  • University of Iowa Hospitals and Clinics

    RECRUITING

    Iowa City, Iowa, 52242, United States

  • University of Michigan Health

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • University of Texas Health Science Center at Houston

    RECRUITING

    Houston, Texas, 77479, United States

  • University of Vermont Medical Center

    RECRUITING

    Burlington, Vermont, 05401, United States

  • University of Virginia Medical Center

    RECRUITING

    Charlottesville, Virginia, 22908, United States

  • Yale New Haven Hospital

    RECRUITING

    New Haven, Connecticut, 05610, United States

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Other studies related to the condition(s) this trial covers.