Aortic Valve Stenosis Clinical Trial
Official title:
Safety and Efficacy Comparison Of Two TAVI Systems in a Prospective Randomized Evaluation II: A Randomized, Controlled, Non-inferiority Trial Evaluating Safety and Clinical Efficacy of the Symetis ACURATE Neo Compared to the Medtronic Evolut R Bioprosthesis in Transfemoral Transcatheter Aortic Valve Implantation
Current care randomized clinical trial comparing the CE marked Symetis ACURATE neo™ Aortic Bioprosthesis and ACURATE TF™ Transfemoral Delivery System with the CE marked Medtronic CoreValve Evolut R TAVI system (or any future CE-marked CoreValve versions).
Transcatheter aortic valve implantation (TAVI) is an established and valuable treatment
option for patients with severe symptomatic aortic stenosis and at high surgical risk for
aortic valve replacement. The use of TAVI is rapidly expanding worldwide and its indications
are widening into intermediate and lower risk populations. However, device comparisons by use
of randomized trials are scarce in particular for newer generation transcatheter valves.
The Symetis ACURATE neo™, a self-expanding transcatheter valve delivered via transfemoral
access, is a second-generation device that gained CE mark approval in June 2014.
The SCOPE-II trial will compare the safety and performance of the Symetis ACURATE neo™ with
the self-expanding Medtronic Evolut R system, a widely used and well-established
transcatheter heart valve, which obtained CE mark in 8NOV2006 and HAS approval on 13JAN2015.
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