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 AViV trial
The objective of this study is to establish the safety and effectiveness of the Edwards SAPIEN X4 system in subjects who are at high or greater surgical risk with a failing aortic bioprosthetic valve.
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Trial design
Eligibility criteria
- Failing aortic bioprosthetic valve demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency
- Bioprosthetic valve size suitable for SAPIEN X4 valve
- New York Heart Association functional class ≥ II
- Heart Team agrees the subject is at high or greater surgical risk
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 AVIV procedural animation
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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 NCT05172973 at ClinicalTrials.gov.
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Caution: Investigational device
Limited by Federal (or United States) law to investigational use.