Transcatheter Replacement of Stenotic Aortic Valve through Implantation of ACURATE in Subjects InDicatEd for TAVR
ACURATE IDE is a prospective, multicenter trial designed to evaluate the safety and effectiveness of the ACURATE Transfemoral Aortic Valve System for TAVR in subjects who have severe native aortic stenosis and are indicated for TAVR. Study cohorts include the following: Randomized Cohort: A prospective, multicenter, 1:1 randomized controlled trial (RCT; ACURATE versus Control [commercially available SAPIEN 3 or CoreValve] TAVR device). Randomization will be stratified by center and by intended control device. Roll-In Cohort: A non-randomized roll-in phase with the test device. Centers that do not have implantation experience with the ACURATE neo™ Aortic Bioprosthesis (transfemoral delivery; Symetis SA, Ecublens, Switzerland) will perform at least 2 roll-in cases before commencing enrollment in the randomized cohort. Centers with prior experience with ACURATE are not required to do roll-in cases. Data from roll-in subjects will be summarized separately from the randomized cohort and will not be included in the primary endpoint analysis.