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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hydra THV Series | Experimental | Self-expanding THV |
|
| Sapien THV Series, MyVal THV Series | Active Comparator | Balloon-expandable THV |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydra THV Series | Device | Transcatheter Aortic Valve Implantation (TAVI) for Patients with Failed Surgical Aortic Bioprosthesis with the use of Hydra THV Series |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Moderate/Severe Prosthesis-Patient Mismatch (PPM) | VARC-3 criteria (iEOA โค0.85 cmยฒ/mยฒ for BMI <30 kg/mยฒ or โค0.70 cmยฒ/mยฒ for BMI โฅ30 kg/mยฒ). | 30 Days |
| Post-TAVI invasive mean aortic pressure gradient |
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"Inclusion Criteria":
"Exclusion criteria":
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Galway | Galway | Ireland |
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| Sapien THV Series and MyVal THV Series | Device | Transcatheter Aortic Valve Implantation (TAVI) for Patients with Failed Surgical Aortic Bioprosthesis with the use of Sapien THV Series and MyVal THV Series |
|
| 30 Days |
| Incidence of VARC-3 Device Success rate |
| 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 | 30 days |
| Myocardial Infarction rate | pre-discharge and 30 days |
| Rate of moderate or severe prosthetic valve regurgitation | pre-discharge and 30 days |
| Rate of new conduction abnormalities | pre-discharge and 30 days |
| Rate of new permanent pacemaker implantation due to procedure-related conduction abnormalities | pre-discharge and 30 days |
| Rate of coronary artery obstruction requiring intervention | 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)] | pre-discharge and 30 days |
| New York Heart Association (NYHA) Functional Classification | pre-procedure , 30 days |
| Quality-of-life, Kansas City Cardiomyopathy Questionnaire (KCCQ) | pre-procedure, and 30 days |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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