The ReTAVI Prospective Observational Registry
Recruiting · NCT05601453 · Observational (researchers observe without assigning treatment) · Lead sponsor: Institut für Pharmakologie und Präventive Medizin
View the official record on ClinicalTrials.gov →Interventions studied
Elective redo transcatheter aortic valve implantation (redo-TAVI)
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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)
Exclusion criteria
- 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
60 locations listed.
- AOU Ospedali Riuniti Ancona, Umberto I, G. M. Lancisi, G. Salesi - Ancona, Italy
- University Heart Center Freiburg Bad Krozingen - Bad Krozingen, Germany
- Kerckhoff-Klinik GmbH, UKGM GmbH - Bad Nauheim, Germany
- Heart and Diabetes Center North Rhine-Westphalia - Bad Oeynhausen, Germany
- Hospital de la Santa Creu i Sant Pau - Barcelona, Spain
- Hospital Clinic de Barcelona - Barcelona, Spain
- Hospital University Germans Trias i Pujol - Barcelona, Spain
- University Hospital of Basel - Basel, Switzerland
- German Heart Center of Charité Berlin - Berlin, Germany
- Medical University of Bialystok - Bialystok, Poland
- BG University Hospital Bergmannsheil gGmbH - Bochum, Germany
- IRCCS Azienda Ospedaliero Universitaria di Bologna - Bologna, Italy
- Centre Hospitalier Universitaire de Bordeaux - Bordeaux, France
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia - Brescia, Italy
- Hospital de Santa Cruz, Carnaxide-Lisabon - Carnaxide, Portugal
- Centre Hospitalier Universitaire de Clermont-Ferrand - Clermont-Ferrand, France
- University Hospital of Duesseldorf - Düsseldorf, Germany
- Elisabeth Hospital, Essen - Essen, Germany
- Careggi Hospital - Florence, Italy
- University Clinical Centre of Gdańsk - Gdansk, Poland
- Hôpitaux universitaires de Genève - Geneva, Switzerland
- LKH-University Hospital and Medical University of Graz - Graz, Austria
- Medical University of Silesia - Katowice, Poland
- University Hospital of Kraków - Krakow, Poland
- Centre hospitalier universitaire vaudois et Université de Lausanne - Lausanne, Switzerland
- Hospital Universitario de León - León, Spain
- Centre Hospitalier Universitaire de Lille - Lille, France
- Kepler University Clinic Linz - Linz, Austria
- Hospices Civils de Lyon - Lyon, France
- Hospital Clinico Universitario San Carlos - Madrid, Spain
- Hôpitaux Universitaires de Marseille Timone - Marseille, France
- Jacques Cartier Private Hospital, Massy - Massy, France
- IRCCS Ospedale Galeazzi Sant'Ambrogio - Milan, Italy
- McGill University Health Centre - Montreal, Canada
- German Heart Centre Munich - Munich, Germany
- Centre Hospitalier Universitaire de Nantes - Nantes, France
- St. Antonius Ziekenhuis, Nieuwegein - Nieuwegein, Netherlands
- Hospital Universitario Central de Asturias - Oviedo, Spain
- Azienda Ospedale-Università Padova (AOUP) - Padua, Italy
- Hôpital Européen Georges-Pompidou - Paris, France
- Hôpital Bichat-Claude-Bernard - Paris, France
- Azienda Ospedaliero-Universitaria Pisana - Pisa, Italy
- Institut Universitaire de Cardiologie et de Pneumologie - Québec, Canada
- Centre hospitalier universitaire de Rennes - Rennes, France
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Roma, Italy
- Policlinici universitari | Sapienza Università di Roma - Roma, Italy
- Centre Hospitalier Universitaire de Rouen - Roubaix, France
- Clinique de la Porte de Paris (CCN) - Saint-Denis, France
- University Hospital St. Pölten - Sankt Pölten, Austria
- Robert-Bosch-Hospital, Stuttgart - Stuttgart, Germany
- Tel Aviv Medical Center - Tel Aviv, Israel
- Centre Hospitalier Universitaire de Toulouse - Toulouse, France
- Università degli Studi di Trieste - Trieste, Italy
- University Hospital Ulm - Ulm, Germany
- St. Paul's Hospital, Vancouver - Vancouver, Canada
- Ospedale San Bortolo di Vicenza - Vicenza, Italy
- Medical University of Vienna - Vienna, Austria
- Hospital Álvaro Cunqueiro, Vigo - Vigo, Spain
- Centro Hospitalar Vila Nova de Gaia / Espinho - Vila Nova de Gaia, Portugal
- Medical University of Warsaw - Warsaw, Poland
Showing 60 of 62 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →