REdo Transcatheter Aortic VALVE Implantation for the Management of Transcatheter Aortic Valve Failure (NCT06557798)
🩺 Plain-English Summary (8th-Grade Level)
Transcatheter aortic valve implantation (TAVI) is a key-hole technique to replace an aortic heart valve that is narrowed and/or leaking. Although TAVI is a safe and effective treatment for a faulty aortic heart valve, the new TAVI valve will not last forever. Because it is a 'tissue' valve (made from the lining of a cow or pig heart), the valve will fail after a period of time as the tissue degenerates. When the TAVI valve fails, a viable treatment option is to perform a 'Redo TAVI' procedure, implanting a second TAVI valve inside the first failing valve. The main purpose of this study is to carefully evaluate patients being treated by Redo TAVI in order to document the short-term and long-term outcomes of the procedure. The study will also obtain information about which factors predict those outcomes. The study will also assess outcomes in patients who present with TAVI valve failure but are not suitable for Redo TAVI, and instead are treated either by open-heart surgery and surgical aortic valve replacement, or by medical therapy (medication). The study will provide doctors the information they need to understand the best way to treat patients who present with TAVI valve failure, and in particular how to perform Redo TAVI procedures with the best possible outcomes for patients.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (1 items) and avoid the listed exclusions (6 items).
Location: Århus Universitetshospital — Aarhus
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Bio-prosthetic Valve Failure due solely to paravalvular aortic 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
- Pregnant or nursing
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (63 Sites)
- Århus Universitetshospital — Aarhus,
- Rigshospitalet — Copenhagen,
- HUS Helsinki University Hospital — Helsinki,
- Turku University Hospital — Turku,
- Clinical Saint Augustin - Elsan — Bordeaux,
- Brest University Hospital Centre — Brest,
- Henri Mondor University Hospital — Créteil,
- ICPS Hôpital privé Jacques-Cartier — Massy,
- Centre Hospitalier Universitaire de Montpellier — Montpellier,
- Hospital Marie Lannelongue — Paris,
- Institute Mutualiste Montsouris — Paris,
- NCT - Saint-Gatien - Alliance — Saint-Cyr-sur-Loire,
- Les Hospital Universitaires de Strasbourg — Strasbourg,
- Clinique Pasteur Toulouse — Toulouse,
- CHRU Hospitals of Tours — Tours,
- Medipole Lyon-Villeurbanne — Villeurbanne,
- Kerckhoff Klinik — Bad Nauheim,
- Herz- und Diabeteszentrum NRW — Bad Oeynhausen,
- Deutsches Herzzentrum Berlin — Berlin,
- Universitatsklinikum Koln (AoR) — Cologne,
- Klinikum Dortmund GmbH - St. Johannes Hospital — Dortmund,
- Herzzentrum Dresden Universitätsklinik — Dresden,
- Universitatsklinikum Dusseldorf (University Hospital Dusseldorf) — Düsseldorf,
- Universitatsklinikum Frankfurt — Frankfurt,
- Asklepios Klinik St. Georg — Hamburg,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.