Clinical Trial

ALLIANCE AVIV: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve in Failing Aortic Bioprosthetic Valves

Recruiting
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Summary
The objective of this study is to establish the safety and effectiveness of the Edwards SAPIEN X4/X4S Transcatheter Heart Valve (THV) in subjects who are at high or greater risk with a failing aortic bioprosthetic valve.
Protocol Amendment History 2 changes
notable Primary completion pushed: 2026-12 -> 2029-03 2026-07-28
minor Completion pushed: 2036-02 -> 2039-12 2026-07-28
Trial Details
NCT Number NCT05172973
Lead Sponsor Edwards Lifesciences
Conditions Aortic Valve Insufficiency, Aortic Valve Stenosis
Enrollment 200 participants
Start Date 2023-11-22
Primary Completion 2029-03 (estimated)
Study Completion 2039-12 (estimated)
Updated on ClinicalTrials.gov 2026-07-27