Status: Not yet recruiting
Self-Expanding Hydra Transcatheter Heart Valve (THV) Series Versus Balloon-Expandable Devices for Valve-In-Valve Transcatheter Aortic Valve Implantation (TAVI) for Patients With Failed Surgical Aortic Bioprosthesis.
This is a prospective, randomised, international, multicentre, open-label, investigator-initiated study in patients undergoing valve-in-valve Transcatheter Aortic Valve Implantation (TAVI) for failed surgical aortic bioprosthesis. A total of 111 patients will be randomized in a 2:1 ratio, with 74 patients assigned to self-expanding Hydra THV Series and 37 patients assigned to BEV (Sapien THV Series and MyVal THV Series).
Participants needed: 111
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: National University of Ireland, Galway, IrelandUpdated: Apr 13, 2026Locations: 1
Eligibility criteria
Male or Female patient ≥18 years of age [+4]
Patients unwilling to provide an informed consent, or whose legal representative... [+13]