The ReTAVI Prospective Observational Registry
Recruiting now
Conditions studied: Structural Valve Deterioration, Structural Valve Degeneration, Symptomatic Patients Who Have Had Transcatheter Heart Valve (THV) Failure, Prosthetic Valve Malfunction, Prosthesis Failure
In brief
Patients with severe aortic stenosis (sAS) treated with transcatheter aortic valve implantation (TAVI) (increasingly younger \& lower risk pts) are experiencing SVD of the index THV and thus developing an indication for a redo-TAVI procedure. The evidence on redo-TAVI (where a transcatheter heart valve \[THV\] is implanted into another THV) is limited, with initial data showing acceptable safety as well efficacy in highly selected and limited populations. Aim is to evaluate short- and long-term data on patients undergoing transcatheter redo-TAVI procedures with THVs for failure of a previously implanted THV and to determine VARC-3 defined efficacy and safety at 30 days and functional outcome at 1 year, 3 years and 5 years.
Key facts
- Study ID
- NCT05601453
- Run by
- Institut für Pharmakologie und Präventive Medizin
- People needed
- 250
- Starts
- 2023-09-05
- Expected to finish
- 2031-12-01
- Last updated by the study team
- 2025-08-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Consecutive patients fulfilling the following criteria:
- Consenting adult patient (≥18 years)
- Procedural success of the first TAVI
- TAVI device failure of the index THV, irrespective of SVD severity
- Intention to treat the patient with a redo-TAVI procedure (SAPIEN family THV)
- The Local Heart Team and the Case Review Board consider the patient suitable and indicated for elective redo-TAVI
- Patient is scheduled to undergo a 30 Day and 12 Months follow-up (both visits taking place in the hospital)
You may not qualify if…
- Patients without signed informed consent / data protection statement (according to requirements of local IRB/IEC)
- Life expectancy below 12 months
- Patients with largely incomplete data with respect to the aims of the project
- Pregnant women at the time of the redo-TAVI
- Note: For all patients included a defined core data set will be collected prospectively. All patients being in accordance with above stated inclusion and exclusion criteria and receiving a balloon-expandable transcatheter aortic valve will be included in the extended documentation.
Where it is running
- Kepler University Clinic Linz — Linz, Austria (enrolling)
- University Hospital St. Pölten — Sankt Pölten, Austria (enrolling)
- Medical University of Vienna — Vienna, Austria (enrolling)
- McGill University Health Centre — Montreal, Canada (enrolling)
- Institut Universitaire de Cardiologie et de Pneumologie — Québec, Canada (enrolling)
- St. Paul's Hospital, Vancouver — Vancouver, Canada (enrolling)
- Centre Hospitalier Universitaire de Bordeaux — Bordeaux, France (enrolling)
- Centre Hospitalier Universitaire de Clermont-Ferrand — Clermont-Ferrand, France (enrolling)
- Centre Hospitalier Universitaire de Lille — Lille, France (enrolling)
- Hospices Civils de Lyon — Lyon, France (enrolling)
- Hôpitaux Universitaires de Marseille Timone — Marseille, France (enrolling)
- Jacques Cartier Private Hospital, Massy — Massy, France (enrolling)
- Centre Hospitalier Universitaire de Nantes — Nantes, France (enrolling)
- Hôpital Européen Georges-Pompidou — Paris, France (enrolling)
- Hôpital Bichat-Claude-Bernard — Paris, France (enrolling)
- Centre hospitalier universitaire de Rennes — Rennes, France (enrolling)
- Centre Hospitalier Universitaire de Rouen — Roubaix, France (enrolling)
- Clinique de la Porte de Paris (CCN) — Saint-Denis, France (enrolling)
- Centre Hospitalier Universitaire de Toulouse — Toulouse, France (enrolling)
- University Heart Center Freiburg Bad Krozingen — Bad Krozingen, Germany (enrolling)
- Kerckhoff-Klinik GmbH, UKGM GmbH — Bad Nauheim, Germany (enrolling)
- Heart and Diabetes Center North Rhine-Westphalia — Bad Oeynhausen, Germany (enrolling)
- German Heart Center of Charité Berlin — Berlin, Germany (enrolling)
- BG University Hospital Bergmannsheil gGmbH — Bochum, Germany (enrolling)
- LKH-University Hospital and Medical University of Graz — Graz, Austria (enrolling)
Full record on ClinicalTrials.gov
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