Aortic Stenosis Clinical Trial
Official title:
Symetis ACURATE TA™ Valve Implantation Using TransApical Access:SAVI2 Registry
Post-market registry on ACURATE TA™ Transapical Aortic Bioprosthesis and ACURATE TA™ Delivery System implantation in patients presenting severe symptomatic aortic stenosis to collect continued surveillance data pertaining to safety and performance of the device.
The SAVI2 registry is a single arm, prospective, multicenter, non-randomized and open
registry up to 1 year follow-up with the Symetis ACURATE TA™.
The ACURATE TA™ is an aortic bioprosthesis for minimal invasive implantation via transapical
access to treat patients with severe symptomatic aortic stenosis where conventional aortic
valve replacement (AVR) via open surgery is considered to be associated with high surgical
risk.
The primary objectives of the registry is to further evaluate the safety and performance of
the implantation and the safety at 30-Day Follow-up.
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