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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
111
Transcatheter Aortic Valve Implantation (TAVI) for Patients with Failed Surgical Aortic Bioprosthesis with the use of Hydra THV Series
Transcatheter Aortic Valve Implantation (TAVI) for Patients with Failed Surgical Aortic Bioprosthesis with the use of Sapien THV Series and MyVal THV Series
University of Galway
Galway, Ireland
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.
Time frame: 30 Days
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).
Time frame: 30 Days
Post-TAVI invasive mean aortic pressure gradient
Time frame: 30 Days
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)
Time frame: 30 Days
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
Time frame: 30 days
Myocardial Infarction rate
Time frame: pre-discharge and 30 days
Rate of moderate or severe prosthetic valve regurgitation
Time frame: pre-discharge and 30 days
Rate of new conduction abnormalities
Time frame: pre-discharge and 30 days
Rate of new permanent pacemaker implantation due to procedure-related conduction abnormalities
Time frame: pre-discharge and 30 days
Rate of coronary artery obstruction requiring intervention
Time frame: pre-discharge
Echocardiographic endpoints
Effective orifice area (EOA) Index effective orifice area (iEOA) Mean aortic valve gradient Peak aortic valve gradient Peak aortic velocity Total aortic regurgitation, transvalvular regurgitation (except baseline) and paravalvular regurgitation (except baseline) Left ventricular ejection fraction (LVEF) Energy lost index (ELI) calculated as \[(EOA x Aortic Cross-Sectional Area)/(Aortic Cross-Sectional Area - EOA)\]
Time frame: pre-discharge and 30 days
New York Heart Association (NYHA) Functional Classification
Time frame: pre-procedure , 30 days
Quality-of-life, Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time frame: pre-procedure, and 30 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.