Sapien 3

Brief summary:

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.

Primary endpoints:

All-cause mortality at 30 days post-index procedure

CERC Services:

CEC

Countries:

France, Germany, Ireland, Italy, United Kingdom

Center number :

17 investigational centers