IRB Study Number 22-663
Status Recruiting
Phase Not Applicable
Location Cleveland Clinic Main Campus
Institute Heart and Vascular Institute
Description
This is a prospective, single arm, multicenter study designed to establish the safety and effectiveness of the Edwards SAPIEN X4 Transcatheter Heart Valve (THV) in subjects with symptomatic, severe, calcific Aortic Stenosis (AS)
Inclusion Criteria
- Severe, Calcific AS as defined by study protocol
- Native aortic annulus size suitable for SAPIEN X4 THV based on CTA analysis
- NYHA Functional Class >/= II
Exclusion Criteria
- Anatomical characteristics that would preclude safe femoral placement of the introducer sheath or safe passage of the delivery system
- Aortic valve is unicuspid, bicuspid or non-calcified
- Pre-existing mechanical or bioprosthetic valve in any position
