NCT05601453Recruiting
The ReTAVI Prospective Observational Registry
Evaluation of Clinical Outcomes of Patients Undergoing a Redo-TAVI Procedure; a Multicenter Prospective Observational Registry
Source: ClinicalTrials.gov · Last updated 16 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 250 (estimated)
- First submitted
- 7 Oct 2022
- Start date
- 5 Sept 2023
- Primary completion date
- Dec 2026
- Lead sponsor
- Institut für Pharmakologie und Präventive Medizin
- NCT number
- NCT05601453
What you commit to
- Study type: Observational
- Planned participants: 250
- From 5 Sept 2023 to the primary completion date, Dec 2026
- 62 sites in 11 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other
- 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
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (62)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| LKH-University Hospital and Medical University of Graz Coordinator of this site? Confirm its status | Graz | Austria | Recruiting |
| Kepler University Clinic Linz Coordinator of this site? Confirm its status | Linz | Austria | Recruiting |
| University Hospital St. Pölten Coordinator of this site? Confirm its status | Sankt Pölten | Austria | Recruiting |
| Medical University of Vienna Coordinator of this site? Confirm its status | Vienna | Austria | Recruiting |
| McGill University Health Centre Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
| Institut Universitaire de Cardiologie et de Pneumologie Coordinator of this site? Confirm its status | Québec | Canada | Recruiting |
| St. Paul's Hospital, Vancouver Coordinator of this site? Confirm its status | Vancouver | Canada | Recruiting |
| University Hospital of Basel Coordinator of this site? Confirm its status | Basel | Switzerland | Recruiting |
| Hôpitaux universitaires de Genève Coordinator of this site? Confirm its status | Geneva | Switzerland | Recruiting |
| Centre hospitalier universitaire vaudois et Université de Lausanne Coordinator of this site? Confirm its status | Lausanne | Switzerland | Recruiting |
| University Heart Center Freiburg - Bad Krozingen Coordinator of this site? Confirm its status | Bad Krozingen | Germany | Recruiting |
| Kerckhoff-Klinik GmbH, UKGM GmbH Coordinator of this site? Confirm its status | Bad Nauheim | Germany | Recruiting |
| Heart and Diabetes Center North Rhine-Westphalia Coordinator of this site? Confirm its status | Bad Oeynhausen | Germany | Recruiting |
| German Heart Center of Charité Berlin Coordinator of this site? Confirm its status | Berlin | Germany | Recruiting |
| BG University Hospital Bergmannsheil gGmbH Coordinator of this site? Confirm its status | Bochum | Germany | Recruiting |
| University Hospital of Duesseldorf Coordinator of this site? Confirm its status | Düsseldorf | Germany | Recruiting |
| Elisabeth Hospital, Essen Coordinator of this site? Confirm its status | Essen | Germany | Recruiting |
| German Heart Centre Munich Coordinator of this site? Confirm its status | Munich | Germany | Recruiting |
| Robert-Bosch-Hospital, Stuttgart Coordinator of this site? Confirm its status | Stuttgart | Germany | Recruiting |
| University Hospital Ulm Coordinator of this site? Confirm its status | Ulm | Germany | Recruiting |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital University Germans Trias i Pujol Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital de la Santa Creu i Sant Pau Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Universitario De Leon Coordinator of this site? Confirm its status | León | Spain | Recruiting |
| Hospital Clínico Universitario San Carlos Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario Central De Asturias Coordinator of this site? Confirm its status | Oviedo | Spain | Recruiting |
| Hospital Álvaro Cunqueiro (Vigo) Coordinator of this site? Confirm its status | Vigo | Spain | Recruiting |
| Centre hospitalier Universitaire de Bordeaux Coordinator of this site? Confirm its status | Bordeaux | France | Recruiting |
| Centre Hospitalier Universitaire de Clermont-Ferrand Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Recruiting |
| Centre Hospitalier Universitaire de Lille Coordinator of this site? Confirm its status | Lille | France | Recruiting |
| Hospices Civils de Lyon Coordinator of this site? Confirm its status | Lyon | France | Recruiting |
| Hôpitaux Universitaires de Marseille Timone Coordinator of this site? Confirm its status | Marseille | France | Recruiting |
| Jacques Cartier Private Hospital, Massy Coordinator of this site? Confirm its status | Massy | France | Recruiting |
| Centre Hospitalier Universitaire de Nantes Coordinator of this site? Confirm its status | Nantes | France | Recruiting |
| Hôpital Européen Georges Pompidou Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Hôpital Bichat - Claude-Bernard Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Centre Hospitalier Universitaire de Rennes Coordinator of this site? Confirm its status | Rennes | France | Recruiting |
| Centre Hospitalier Universitaire de Rouen Coordinator of this site? Confirm its status | Roubaix | France | Recruiting |
| Clinique de la Porte de Paris (CCN) Coordinator of this site? Confirm its status | Saint-Denis | France | Recruiting |
| Centre Hospitalier Universitaire de Toulouse Coordinator of this site? Confirm its status | Toulouse | France | Recruiting |
| Tel Aviv Medical Center Coordinator of this site? Confirm its status | Tel Aviv | Israel | Recruiting |
| AOU Ospedali Riuniti Ancona, Umberto I, G. M. Lancisi, G. Salesi Coordinator of this site? Confirm its status | Ancona | Italy | Withdrawn |
| IRCCS Azienda Ospedaliero-Universitaria di Bologna Coordinator of this site? Confirm its status | Bologna | Italy | Recruiting |
| Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Coordinator of this site? Confirm its status | Brescia | Italy | Recruiting |
| Careggi Hospital Coordinator of this site? Confirm its status | Florence | Italy | Recruiting |
| IRCCS Ospedale Galeazzi Sant'Ambrogio Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Azienda Ospedale-Università Padova (AOUP) Coordinator of this site? Confirm its status | Padua | Italy | Recruiting |
| Azienda Ospedaliero Universitaria Pisana Coordinator of this site? Confirm its status | Pisa | Italy | Recruiting |
| Policlinici universitari | Sapienza Università di Roma Coordinator of this site? Confirm its status | Roma | Italy | Recruiting |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Roma | Italy | Recruiting |
| Università degli Studi di Trieste Coordinator of this site? Confirm its status | Trieste | Italy | Recruiting |
| Ospedale San Bortolo di Vicenza Coordinator of this site? Confirm its status | Vicenza | Italy | Recruiting |
| St. Antonius Ziekenhuis Nieuwegein Coordinator of this site? Confirm its status | Nieuwegein | Netherlands | Recruiting |
| Medical University of Bialystok Coordinator of this site? Confirm its status | Bialystok | Poland | Recruiting |
| University Clinical Centre of Gdańsk Coordinator of this site? Confirm its status | Gdansk | Poland | Withdrawn |
| Medical University of Silesia Coordinator of this site? Confirm its status | Katowice | Poland | Withdrawn |
| University Hospital of Kraków Coordinator of this site? Confirm its status | Krakow | Poland | Recruiting |
| Institute of Cardiology, Warsaw Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| Medical University of Warsaw Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| Wroclaw Medical University Coordinator of this site? Confirm its status | Wroclaw | Poland | Recruiting |
| Hospital de Santa Cruz, Carnaxide-Lisabon Coordinator of this site? Confirm its status | Carnaxide | Portugal | Recruiting |
| Centro Hospitalar Vila Nova de Gaia/Espinho Coordinator of this site? Confirm its status | Vila Nova de Gaia | Portugal | Recruiting |
Related publications
- Early outcomes of redo-TAVI with the SAPIEN 3 platform: the prospective, multicentre ReTAVI registry.EuroIntervention · 2026 · PMID 42219979
This page is information, not medical advice. Discuss any trial with your doctor.