The ALLIANCE trial
One clinical program, multiple clinical trials
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.
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Trial design
Eligibility criteria
- Severe, calcific aortic stenosis
- Native aortic annulus size suitable for SAPIEN X4 THV
- NYHA functional class ≥ II
Study device
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
We’re here for you
We are committed to providing the highest levels of customer service to help our patients improve their quality of life. For any questions, please contact the Edwards Patient Support Center.
For details about the trial, visit NCT05172960 at ClinicalTrials.gov.
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Caution: Investigational device
Limited by Federal (or United States) law to investigational use.