Edwards Lifesciences
The objective of this study is to establish the safety and effectiveness of the Edwards SAPIEN X4/X4S Transcatheter Heart Valve (THV) in subjects with symptomatic, severe, calcific aortic stenosis (AS).
This is a prospective, single arm, multicenter study. Subjects with bicuspid aortic valve morphology will be enrolled in a separate registry.
Inclusion Criteria: 1. Severe, calcific AS 2. Native aortic annulus size suitable for SAPIEN X4 THV 3. NYHA functional class ≥ II 4. The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent. Exclusion Criteria: 1. Anatomical characteristics that would preclude safe femoral placement of the introducer sheath or safe passage of the delivery system 2. Aortic valve is unicuspid, bicuspid or non-calcified 3. Pre-existing mechanical or bioprosthetic valve in any position 4. Severe aortic regurgitation (\> 3+) 5. Severe mitral reg…
Implantation of the SAPIEN X4 valve
Implantation of the SAPIEN X4S valve