ACURATE IDE

Brief summary:

The objective of ACURATE IDE is to evaluate safety and effectiveness of the ACURATE Transfemoral Aortic Valve System for transcatheter aortic valve replacement (TAVR) in subjects with severe native aortic stenosis who are indicated for TAVR.

Primary endpoints:

Safety : Composite of all-cause mortality, all stroke, life-threatening and major bleeding, stage 2 and 3 acute kidney injury and major vascular complications at 30 days.

Effectiveness : Composite of all-cause mortality and disabling stroke at 1 year.

CERC Services:

CEC

Countries:

Canada, USA

Center number :

50 investigational centers