ACURATE IDE Trial Overview
Study Objectives
To evaluate safety and effectiveness of the transfemoral ACURATE™ Aortic Valve Platform for transcatheter aortic valve replacement (TAVR) in subjects with severe native aortic stenosis who are indicated for TAVR.
Study Focus
The ACURATE Valve Platform is intended to improve aortic valve function in subjects with severe native aortic stenosis who are indicated for TAVR.
Patient Selection
Symptomatic Subjects with Severe Aortic Stenosis
Timeline (applies to all cohorts in the study)
After the procedure, the trial outcome measures for participants and the valves will be regularly evaluated.
Test Device and Sizes
The transfemoral ACURATE Aortic Valve Platform (ACURATE) consists of the following:
The ACURATE neo2 Valve, in sizes Small (23mm), Medium (25mm), and Large (27mm) nominal diameters at waist level. Includes three main components: a three-leaflet porcine pericardial bioprosthetic aortic valve; a self-expandable Nitinol stent; and a double porcine pericardium skirt sutured on the inner and outer surface of the stent to prevent paravalvular leaks. Introduced percutaneously via the iliofemoral artery.
The ACURATE neo2 Tranfemoral (TF) Delivery System. The delivery system is compatible with all 3 valve sizes. Allows positioning and delivery of the transcatheter valve via iliofemoral access.
The ACURATE Prime Valve XL, in size Extra Large (29 mm) nominal diameters at waist level. Includes the same three main components: a three-leaflet porcine pericardial bioprosthetic aortic valve; a self-expandable Nitinol stent; and a double porcine pericardium skirt sutured on the inner and outer surface of the stent to prevent paravalvular leaks. Introduced percutaneously via the iliofemoral artery.
The ACURATE Prime Transfemoral (TF) Delivery System XL, compatible with the ACURATE Prime XL Valve size. Allows positioning and delivery of the transcatheter ACURATE Valve XL via iliofemoral access.
Control Device and Sizes
Subjects assigned to the control arm will receive a commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device that is introduced percutaneously via the femoral artery using conventional catheterization techniques. Every subject in the main randomized and extended durability cohorts must be deemed treatable with an available size of both the test (ACURATE) device and the control device.
