Evaluation of Clinical Outcomes of Patients Undergoing a Redo-TAVI Procedure; a Multicenter Prospective Observational Registry

Status: Recruiting
Location: See all (62) locations...
Intervention Type: Procedure
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ 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)

Locations
Other Locations
Austria
LKH-University Hospital and Medical University of Graz
RECRUITING
Graz
Kepler University Clinic Linz
RECRUITING
Linz
University Hospital St. Pölten
RECRUITING
Sankt Pölten
Medical University of Vienna
RECRUITING
Vienna
Canada
McGill University Health Centre
RECRUITING
Montreal
Institut Universitaire de Cardiologie et de Pneumologie
RECRUITING
Québec
St. Paul's Hospital, Vancouver
RECRUITING
Vancouver
France
Centre Hospitalier Universitaire de Bordeaux
RECRUITING
Bordeaux
Centre Hospitalier Universitaire de Clermont-Ferrand
RECRUITING
Clermont-ferrand
Centre Hospitalier Universitaire de Lille
RECRUITING
Lille
Hospices Civils de Lyon
RECRUITING
Lyon
Hôpitaux Universitaires de Marseille Timone
RECRUITING
Marseille
Jacques Cartier Private Hospital, Massy
RECRUITING
Massy
Centre Hospitalier Universitaire de Nantes
RECRUITING
Nantes
Hôpital Bichat-Claude-Bernard
RECRUITING
Paris
Hôpital Européen Georges-Pompidou
RECRUITING
Paris
Centre hospitalier universitaire de Rennes
RECRUITING
Rennes
Centre Hospitalier Universitaire de Rouen
RECRUITING
Roubaix
Clinique de la Porte de Paris (CCN)
RECRUITING
Saint-denis
Centre Hospitalier Universitaire de Toulouse
RECRUITING
Toulouse
Germany
University Heart Center Freiburg Bad Krozingen
RECRUITING
Bad Krozingen
Kerckhoff-Klinik GmbH, UKGM GmbH
RECRUITING
Bad Nauheim
Heart and Diabetes Center North Rhine-Westphalia
RECRUITING
Bad Oeynhausen
German Heart Center of Charité Berlin
RECRUITING
Berlin
BG University Hospital Bergmannsheil gGmbH
RECRUITING
Bochum
University Hospital of Duesseldorf
RECRUITING
Düsseldorf
Elisabeth Hospital, Essen
RECRUITING
Essen
German Heart Centre Munich
RECRUITING
Munich
Robert-Bosch-Hospital, Stuttgart
RECRUITING
Stuttgart
University Hospital Ulm
RECRUITING
Ulm
Israel
Tel Aviv Medical Center
RECRUITING
Tel Aviv
Italy
AOU Ospedali Riuniti Ancona, Umberto I, G. M. Lancisi, G. Salesi
WITHDRAWN
Ancona
IRCCS Azienda Ospedaliero Universitaria di Bologna
RECRUITING
Bologna
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
RECRUITING
Brescia
Careggi Hospital
RECRUITING
Florence
IRCCS Ospedale Galeazzi Sant'Ambrogio
RECRUITING
Milan
Azienda Ospedale-Università Padova (AOUP)
RECRUITING
Padua
Azienda Ospedaliero-Universitaria Pisana
RECRUITING
Pisa
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
RECRUITING
Roma
Policlinici universitari | Sapienza Università di Roma
RECRUITING
Roma
Università degli Studi di Trieste
RECRUITING
Trieste
Ospedale San Bortolo di Vicenza
RECRUITING
Vicenza
Netherlands
St. Antonius Ziekenhuis, Nieuwegein
RECRUITING
Nieuwegein
Poland
Medical University of Bialystok
RECRUITING
Bialystok
University Clinical Centre of Gdańsk
WITHDRAWN
Gdansk
Medical University of Silesia
WITHDRAWN
Katowice
University Hospital of Kraków
RECRUITING
Krakow
Institute of Cardiology Warsaw
RECRUITING
Warsaw
Medical University of Warsaw
RECRUITING
Warsaw
Wroclaw Medical University
RECRUITING
Wroclaw
Portugal
Hospital de Santa Cruz, Carnaxide-Lisabon
RECRUITING
Carnaxide
Centro Hospitalar Vila Nova de Gaia / Espinho
RECRUITING
Vila Nova De Gaia
Spain
Hospital Clinic de Barcelona
RECRUITING
Barcelona
Hospital de la Santa Creu i Sant Pau
RECRUITING
Barcelona
Hospital University Germans Trias i Pujol
RECRUITING
Barcelona
Hospital Universitario de León
RECRUITING
León
Hospital Clinico Universitario San Carlos
RECRUITING
Madrid
Hospital Universitario Central de Asturias
RECRUITING
Oviedo
Hospital Álvaro Cunqueiro, Vigo
RECRUITING
Vigo
Switzerland
University Hospital of Basel
RECRUITING
Basel
Hôpitaux universitaires de Genève
RECRUITING
Geneva
Centre hospitalier universitaire vaudois et Université de Lausanne
RECRUITING
Lausanne
Contact Information
Primary
Claudia Lüske, PhD
claudia.lueske@ippmed.de
044718503324
Backup
Daniel Greinert
daniel.greinert@ippmed.de
044718503328
Time Frame
Start Date: 2023-09-05
Estimated Completion Date: 2031-12
Participants
Target number of participants: 250
Treatments
redo-TAVI patients
Patients with severe aortic stenosis (sAS) treated with TAVI developing SVD and thus an indication for redo-TAVI procedure
Sponsors
Collaborators: Edwards Lifesciences
Leads: Institut für Pharmakologie und Präventive Medizin

This content was sourced from clinicaltrials.gov