To evaluate safety and effectiveness of the ACURATE neo2™ Transfemoral Aortic Valve System for transcatheter aortic valve replacement (TAVR) in subjects with severe native aortic stenosis who are indicated for TAVR.
In April 2021, the FDA approved modifying the trial design to include patients across all surgical risk levels – including the low risk population – who are deemed suitable for TAVR by the heart team. As part of this approval, the number of expected enrollments in the clinical trial was expanded to 1,500 randomized patients, up from the previous approved study design of 1,050.
Planned Indication(s) for Use
The ACURATE neo2 Transfemoral Aortic Valve System is intended to improve aortic valve function in subjects with severe native aortic stenosis who are indicated for TAVR.
After the procedure, the trial outcome measures for participants and the valves will be regularly evaluated.
Test Device and Sizes
The ACURATE Transfemoral Aortic Valve System (ACURATE) consists of the following:
ACURATE neo2 Aortic 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.
ACURATE neo2 Transfemoral Delivery System. The delivery system is compatible with all 3 valve sizes. Allows positioning and delivery of the transcatheter valve 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 randomized cohort must be deemed treatable with an available size of both the test (ACURATE) device and the control device.
For the full trial overview, visit the ACURATE IDE page: