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).
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.
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)
Patients with non-transfemoral TAVI access.
Surgical or transcatheter valve in mitral position (mitral rings are not an exclusion)
Parallel
Hydra THV Series
DeviceTranscatheter Aortic Valve Implantation (TAVI) for Patients with Failed Surgical Aortic Bioprosthesis with the use of Hydra THV Series
Sapien THV Series and MyVal THV Series
DeviceTranscatheter Aortic Valve Implantation (TAVI) for Patients with Failed Surgical Aortic Bioprosthesis with the use of Sapien THV Series and MyVal THV Series
Mean pressure gradient across the aortic valve.
The objective is to demonstrate that the self-expanding Hydra THV series is non-inferior, and potentially superior, to balloon-expandable valves (Sapien and MyVal THV series) in terms of hemodynamic performance for patients undergoing ViV TAVI for failed surgical aortic bioprostheses.
Incidence of Moderate/Severe Prosthesis-Patient Mismatch (PPM)
VARC-3 criteria (iEOA ≤0.85 cm²/m² for BMI \<30 kg/m² or ≤0.70 cm²/m² for BMI ≥30 kg/m²).
Post-TAVI invasive mean aortic pressure gradient
Incidence of VARC-3 Device Success rate
* Technical success * Freedom from mortality * Freedom from surgery or intervention related to the device or to a major vascular or access-related or cardiac structural complication * VARC3 Intended performance of the valve (mean gradient \<20 mmHg, peak velocity \<3 m/s, Doppler velocity index \>0.25, and less than moderate aortic regurgitation)
Freedom from Early safety composite endpoint (rate at 30 days)
freedom from all-cause mortality freedom from all stroke freedom from VARC type 2-4 bleeding freedom from major vascular, access-related, or cardiac structural complication freedom from acute kidney injury stage 3 or 4 freedom from moderate or severe aortic regurgitation freedom from new permanent pacemaker due to procedure-related conduction abnormalities freedom from surgery or intervention related to the device
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