Self-Expanding Hydra Transcatheter Heart Valve (THV) Series Versus Balloon-Expandable Devices for… (NCT07524595) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
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.
Ireland111 participantsStarted 2026-04
Plain-language summary
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).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Male or Female patient ≥18 years of age
✓. Severe hemodynamic valve deterioration of a surgically implanted bioprosthetic aortic valve, including severe valve stenosis and/or severe valve regurgitation, as determined by the Heart Team assessment
✓. Patients eligible for transfemoral TAVI with both study THV platforms per heart team consensus.
✓. TAVI (with or without fracture of surgical valve) is suitable with commercially available sizes of both Hydra and Sapien/Myvall BEVs.
✓. Patient has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Ethics Committee and is willing to comply with all protocol-required (follow-up) evaluations.
Exclusion criteria
✕. Patients unwilling to provide an informed consent, or whose legal representative object to their participation in the study
✕. Patient is a woman who is pregnant or nursing (a pregnancy test must be performed within 7 days prior to the index procedure in woman of child-bearing potential according to local practice)
What they're measuring
1
Mean pressure gradient across the aortic valve.
Timeframe: 30 Days
Trial details
NCT IDNCT07524595
SponsorNational University of Ireland, Galway, Ireland