The ReTAVI Prospective Observational Registry

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.

Conditions

• Structural Valve Deterioration
• Structural Valve Degeneration
• Symptomatic Patients Who Have Had Transcatheter Heart Valve (THV) Failure
• Prosthetic Valve Malfunction
• Prosthesis Failure

Interventions

PROCEDURE

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)

Sponsors & Collaborators

• Edwards Lifesciences

  collaborator INDUSTRY

• Institut für Pharmakologie und Präventive Medizin

  lead NETWORK

Principal Investigators

• Giuseppe Tarantini, Prof. · University of Padua Medical School, Padua, Italy

• Radoslaw Parma, Dr. · Medical University of Silesia, Katowice, Poland

• Thomas Cuisset, Prof. · Centre Hospitalier Universitaire de Timone, Marseille, France

• Victoria Delgado, Prof. · University Hospital Germans Trias i Pujol, Badalona, Spain

• Michael Joner, Prof. · German Heart Center, Technical University of Munich, Munich, Germany

• Thomas Modine, Prof. · Hopital Haut Levêque - Centre Hospitalier Universitaire de Bordeaux, France

• Josep Rodés-Cabau, Prof. · nstitut Universitaire de Cardiologie et de Pneumologie de Québec, Canada

• Francesco Saia, Prof. · University Hospital of Bologna, Policlinico S. Orsola-Malpighi, Bologna, Italy

• Hector A. Alvarez Covarrubias, MD · Department of Cardiology, Munich Heart Center, Technical University of Munich, Germany

• Ginatutas Bieliauskas, MD · Department Interventional Cardiology, The Heart Center, Rigshospitalet, University of Copenhagen, Coppenhagen, Denmark

• Luca Nai Fovino, MD · Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padua Medical School, Padua, Italy

• Eric Van Belle, MD · Interventional Cardiology, Centre Hospitalier Universitaire de Lille, France

• Rafał Wolny, MD · Department of Interventional Cardiology and Angiology, National Institute of Cardiology, Warsaw, Poland

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-09-05

Primary Completion

2026-12-31

Completion

2031-12-31

Countries

• Austria
• Canada
• France
• Germany
• Israel
• Italy
• Netherlands
• Poland
• Portugal
• Spain
• Switzerland

Study Locations