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The ReTAVI Prospective Observational Registry
Sponsor: Institut für Pharmakologie und Präventive Medizin
Summary
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.
Official title: Evaluation of Clinical Outcomes of Patients Undergoing a Redo-TAVI Procedure; a Multicenter Prospective Observational Registry
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
250
Start Date
2023-09-05
Completion Date
2031-12
Last Updated
2025-08-20
Healthy Volunteers
No
Conditions
Interventions
Elective redo transcatheter aortic valve implantation (redo-TAVI)
Elective redo-TAVI procedure with the intention to treat the patient with a SAPIEN family valve implantation (currently the only registered medical devices for redo-TAVI use)
Locations (62)
LKH-University Hospital and Medical University of Graz
Graz, Austria
Kepler University Clinic Linz
Linz, Austria
University Hospital St. Pölten
Sankt Pölten, Austria
Medical University of Vienna
Vienna, Austria
McGill University Health Centre
Montreal, Canada
Institut Universitaire de Cardiologie et de Pneumologie
Québec, Canada
St. Paul's Hospital, Vancouver
Vancouver, Canada
Centre Hospitalier Universitaire de Bordeaux
Bordeaux, France
Centre Hospitalier Universitaire de Clermont-Ferrand
Clermont-Ferrand, France
Centre Hospitalier Universitaire de Lille
Lille, France
Hospices Civils de Lyon
Lyon, France
Hôpitaux Universitaires de Marseille Timone
Marseille, France
Jacques Cartier Private Hospital, Massy
Massy, France
Centre Hospitalier Universitaire de Nantes
Nantes, France
Hôpital Européen Georges-Pompidou
Paris, France
Hôpital Bichat-Claude-Bernard
Paris, France
Centre hospitalier universitaire de Rennes
Rennes, France
Centre Hospitalier Universitaire de Rouen
Roubaix, France
Clinique de la Porte de Paris (CCN)
Saint-Denis, France
Centre Hospitalier Universitaire de Toulouse
Toulouse, France
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
German Heart Center of Charité Berlin
Berlin, Germany
BG University Hospital Bergmannsheil gGmbH
Bochum, Germany
University Hospital of Duesseldorf
Düsseldorf, Germany
Elisabeth Hospital, Essen
Essen, Germany
German Heart Centre Munich
Munich, Germany
Robert-Bosch-Hospital, Stuttgart
Stuttgart, Germany
University Hospital Ulm
Ulm, Germany
Tel Aviv Medical Center
Tel Aviv, Israel
AOU Ospedali Riuniti Ancona, Umberto I, G. M. Lancisi, G. Salesi
Ancona, Italy
IRCCS Azienda Ospedaliero Universitaria di Bologna
Bologna, Italy
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Brescia, Italy
Careggi Hospital
Florence, Italy
IRCCS Ospedale Galeazzi Sant'Ambrogio
Milan, Italy
Azienda Ospedale-Università Padova (AOUP)
Padua, Italy
Azienda Ospedaliero-Universitaria Pisana
Pisa, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Italy
Policlinici universitari | Sapienza Università di Roma
Roma, Italy
Università degli Studi di Trieste
Trieste, Italy
Ospedale San Bortolo di Vicenza
Vicenza, Italy
St. Antonius Ziekenhuis, Nieuwegein
Nieuwegein, Netherlands
Medical University of Bialystok
Bialystok, Poland
University Clinical Centre of Gdańsk
Gdansk, Poland
Medical University of Silesia
Katowice, Poland
University Hospital of Kraków
Krakow, Poland
Medical University of Warsaw
Warsaw, Poland
Institute of Cardiology Warsaw
Warsaw, Poland
Wroclaw Medical University
Wroclaw, Poland
Hospital de Santa Cruz, Carnaxide-Lisabon
Carnaxide, Portugal
Centro Hospitalar Vila Nova de Gaia / Espinho
Vila Nova de Gaia, Portugal
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Hospital Clinic de Barcelona
Barcelona, Spain
Hospital University Germans Trias i Pujol
Barcelona, Spain
Hospital Universitario de León
León, Spain
Hospital Clinico Universitario San Carlos
Madrid, Spain
Hospital Universitario Central de Asturias
Oviedo, Spain
Hospital Álvaro Cunqueiro, Vigo
Vigo, Spain
University Hospital of Basel
Basel, Switzerland
Hôpitaux universitaires de Genève
Geneva, Switzerland
Centre hospitalier universitaire vaudois et Université de Lausanne
Lausanne, Switzerland