Study detail
RecruitingObservational
Safety and Effectiveness of Balloon-Expandable Bioprosthetic SAPIEN X4 Transcatheter Heart Valve in Failing Aortic Bioprosthetic Valves
Edwards Lifesciences
Summary
The objective of this study is to establish the safety and effectiveness of the Edwards SAPIEN X4 Transcatheter Heart Valve (THV) in subjects who are at high or greater risk with a failing aortic bioprosthetic valve.
Description
Prospective, single arm, multicenter study
Eligibility
- Age range
- Not specified
- Sex
- All
- Healthy volunteers
- No
Detailed criteria