Clinical Trial

Comparison of Allegra vs Sapien Transcatheter Aortic Valves in Valve-In-Valve Indication

Recruiting
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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.
Protocol Amendment History 14 amendments
This ClinicalTrials.gov record has been amended 14 times since 2023-09-17; most recent amendment 2026-06-12.
Status change: Not Yet Recruiting → Recruiting 2024-02-01
Trial Details
NCT Number NCT06049654
Lead Sponsor Fundación EPIC
Conditions Aortic Valve Stenosis, Structural Valve Deterioration
Enrollment 104 participants
Start Date 2024-02-01
Primary Completion 2027-11-01 (estimated)
Study Completion 2027-11-01 (estimated)
Updated on ClinicalTrials.gov 2026-06-15