SAPIEN X4 Transcatheter Heart Valve for Failing Aortic Valves
This study is testing the safety and effectiveness of the SAPIEN X4/X4S Transcatheter Heart Valve (THV) in people whose existing aortic bioprosthetic valve is failing. You might be able to join if your current valve has moderate or worse narrowing (stenosis) or leaking (insufficiency), and your heart team believes surgery is too risky for you. The study will look at how many people experience death or stroke within one year after receiving the SAPIEN X4/X4S THV. This study aims to enroll about 200 participants, but its current recruitment status is unclear.
- Study design
- This is a single-arm study, meaning all participants will receive the SAPIEN X4/X4S THV. It is planned to include 200 participants across multiple centers.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will track participants for at least one year to measure outcomes like death and stroke.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
ALLIANCE AVIV: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve in Failing Aortic Bioprosthetic Valves
At a glance
Conditions
Where it's being run
36 sites across 22 statesStudy leadership
- Robert Cubbedu, MD · PRINCIPAL_INVESTIGATOR · Naples Community Hospital
Who to contact
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What this trial measures
- Non-hierarchical composite of death and stroke1 year
The number of patients that died or had a stroke