The objective of Sapien 3 is to assess the safety and device success of the Edwards SAPIEN 3 Transcatheter Heart Valve (S3 THV) and the Edwards Commander transfemoral and Certitude transapical/transaortic Delivery Systems in patients with symptomatic, severe aortic stenosis who are indicated for aortic valve replacement.
All-cause mortality at 30 days post-index procedure
France, Germany, Ireland, Italy, United Kingdom
Center number :
17 investigational centers