NCT06049654 Comparison of Allegra vs Sapien Transcatheter Aortic Valves in Valve-In-Valve Indication
| NCT ID | NCT06049654 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fundación EPIC |
| Condition | Aortic Valve Stenosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 104 participants |
| Start Date | 2024-02-01 |
| Primary Completion | 2026-11-01 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
The VIVALL-2 study is a randomized trial to compare the self-expandable supra-annular Allegra and the balloon-expandable intra-annular Edwards transcatheter valve systems in patients with degenerated biological aortic surgical valve.
Eligibility Criteria
Inclusion Criteria: Patients meeting ALL the following criteria will be included: * Patients aged ≥ 18 years. * Severe haemodynamical valve deterioration of a biological aortic valve implanted surgically, including severe valve stenosis (effective aortic valve area \< 1.0 cm2) and/or severe valve regurgitation. * The patient has cardiac symptoms and/or deterioration of left ventricular ejection fraction attributable to the aortic valve disease. * Heart team decision of VIV procedure. * Patient is willing to return at 30 days for TTE and to be clinically contacted at 1 year. Exclusion Criteria: Patients meeting, at least, 1 of the following criteria will be excluded: * Patients who openly express their refusal to participate in the study. * Female patients in gestational age. * Presence or suspicious of biological aortic valve thrombosis. * Known hypersensitivity or contraindication to antithrombotic therapy (or inability to be anticoagulated during the procedure), nitinol, or sensitivi