ACURATE IDE

Structural Heart Disease

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.

ID: NCT03735667

Last publication: ACURATE neo2 valve versus commercially available transcatheter heart valves in patients with severe aortic stenosis (ACURATE IDE): a multicentre, randomised, controlled, non-inferiority trial | CERC

 Sponsor

Boston Scientific

 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

  • Clinical Events Committee (CEC) activities

 Countries

Canada, USA

 Number of investigational sites

50

 Number of patients

1948