REdo Transcatheter Aortic VALVE Implantation for the Management of Transcatheter Aortic Valve Failure
Recruiting now
Conditions studied: Aortic Valve Stenosis
In brief
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.
Key facts
- Study ID
- NCT06557798
- Run by
- The Leeds Teaching Hospitals NHS Trust
- People needed
- 550
- Starts
- 2024-12-12
- Expected to finish
- 2033-03-01
- Last updated by the study team
- 2026-06-25
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Bio-prosthetic Valve Failure (BVF) of a Transcatheter Aortic Valve requiring possible reintervention
You may not qualify if…
- 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
Where it is running
- Aalborg Universitethospital — Aalborg, Denmark (enrolling)
- Rigshospitalet — Copenhagen, Denmark (enrolling)
- HUS Helsinki University Hospital — Helsinki, Finland (enrolling)
- Århus Universitetshospital — Aarhus, Denmark (enrolling)
- Clinical Saint Augustin - Elsan — Bordeaux, France (enrolling)
- Brest University Hospital Centre — Brest, France (enrolling)
- Henri Mondor University Hospital — Créteil, France (enrolling)
- ICPS Hôpital privé Jacques-Cartier — Massy, France (enrolling)
- Turku University Hospital — Turku, Finland (enrolling)
- University Hospital of Nimes — Nîmes, France (enrolling)
- Hospital Marie Lannelongue — Paris, France (enrolling)
- Institute Mutualiste Montsouris — Paris, France (enrolling)
- Les Hospital Universitaires de Strasbourg — Strasbourg, France (enrolling)
- Clinique Pasteur Toulouse — Toulouse, France (enrolling)
- CHRU Hospitals of Tours — Tours, France (enrolling)
- Medipole Lyon-Villeurbanne — Villeurbanne, France (enrolling)
- Kerckhoff Klinik — Bad Nauheim, Germany (enrolling)
- Herz- und Diabeteszentrum NRW — Bad Oeynhausen, Germany (enrolling)
- Centre Hospitalier Universitaire de Montpellier — Montpellier, France (enrolling)
- Universitatsklinikum Koln (AoR) — Cologne, Germany (enrolling)
- Klinikum Dortmund GmbH - St. Johannes Hospital — Dortmund, Germany (enrolling)
- Herzzentrum Dresden Universitätsklinik — Dresden, Germany (enrolling)
- Universitatsklinikum Dusseldorf (University Hospital Dusseldorf) — Düsseldorf, Germany (enrolling)
- Universitatsklinikum Frankfurt — Frankfurt, Germany (enrolling)
- Asklepios Klinik St. Georg — Hamburg, Germany (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.