Safety and Effectiveness of Balloon-Expandable Bioprosthetic SAPIEN X4 Transcatheter Heart Valve
The objective of this study is to establish the safety and effectiveness of the Edwards SAPIEN X4 Transcatheter Heart Valve (THV) in subjects with symptomatic, severe, calcific aortic stenosis (AS).
- Severe, calcific AS
- Native aortic annulus size suitable for SAPIEN X4 THV
- NYHA functional class ≥ II
- The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.