The ALLIANCE pivotal trial
The objective of the ALLIANCE pivotal trial is to establish the safety and effectiveness of the Edwards SAPIEN X4 valve in patients with symptomatic, severe, calcific aortic stenosis.
Now enrolling
The ALLIANCE program currently consists of two clinical trials: The ALLIANCE trial (pivotal study) and the ALLIANCE aortic valve-in-valve (AViV) trial.
The objective of the ALLIANCE pivotal trial is to establish the safety and effectiveness of the Edwards SAPIEN X4 valve in patients with symptomatic, severe, calcific aortic stenosis.
The objective of the ALLIANCE AViV trial is to establish the safety and effectiveness of the Edwards SAPIEN X4 valve in patients who are at high or greater surgical risk with a failing aortic bioprosthetic valve.
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Limited by Federal (or United States) law to investigational use.