The ReTAVI Prospective Observational Registry

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.

NCT Number	NCT05601453
Lead Sponsor	Institut für Pharmakologie und Präventive Medizin Collaborators: Edwards Lifesciences
Conditions	Structural Valve Deterioration, Structural Valve Degeneration, Symptomatic Patients Who Have Had Transcatheter Heart Valve (THV) Failure, Prosthetic Valve Malfunction, Prosthesis Failure
Enrollment	250 participants
Start Date	2023-09-05
Primary Completion	2026-12 (estimated)
Study Completion	2031-12 (estimated)
Updated on ClinicalTrials.gov	2025-08-20