IRB Study Number 23-1295
Status Recruiting
Phase Not Applicable
Location Cleveland Clinic Main Campus
Institute Heart and Vascular Institute
Description
A prospective, single arm, multicenter, pivotal study to establish the safety and effectiveness of the Edwards SAPIEN X4 Transcatheter Heart Valve (THV) in subjects who are at high or greater surgical risk with a failing aortic bioprosthetic valve
Inclusion Criteria
- Failing aortic bioprosthetic valve demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency
- Bioprosthetic valve size suitable for SAPIEN X4 THV based on computed tomography angiography (CTA) analysis
- Heart Team agrees the subject is at high or greater surgical risk
- Additional inclusion criteria will be assessed by study staff
Exclusion Criteria
- Anatomical characteristics that would preclude safe femoral placement of the introducer sheath or safe passage of the delivery system
- Failing valve has moderate or severe paravalvular regurgitation
- Failing valve is unstable, rocking, or not structurally intact
- Additional inclusion criteria will be assessed by study staff
