Clinical Trial

ALLIANCE: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve

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 with symptomatic, severe, calcific aortic stenosis (AS).
Protocol Amendment History 2 changes
critical Trial status changed: Active, Not Recruiting → Recruiting 2026-07-09
notable Primary completion pushed: 2025-07-22 -> 2027-07 2026-06-23
Trial Details
NCT Number NCT05172960
Lead Sponsor Edwards Lifesciences
Conditions Aortic Stenosis, Severe
Enrollment 1,234 participants
Start Date 2022-06-20
Primary Completion 2027-07 (estimated)
Study Completion 2037-01 (estimated)
Updated on ClinicalTrials.gov 2026-08-11