The ALLIANCE program consists of two clinical trials: The ALLIANCE trial (pivotal study) and the ALLIANCE aortic valve-in-valve (AViV) trial, each for a different patient condition.
About the ALLIANCE trial
The objective of the ALLIANCE trial (pivotal) is to establish the safety and effectiveness of the Edwards next-generation SAPIEN X4 valve in patients with symptomatic, severe, calcific aortic stenosis.
Native aortic annulus size suitable for SAPIEN X4 THV
NYHA functional class ≥ II
The SAPIEN X4 system's adjustable valve sizing and commissural alignment are being studied in this trial. The SAPIEN X4 valve incorporates RESILIA tissue, which is created with a novel technology called Edwards Integrity Preservation.
The SAPIEN X4 system pivotal procedural animation
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