Last updated on November 2019

Safety and Efficacy Comparison Of Two TAVI Systems in a Prospective Randomized Evaluation II

Brief description of study

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). The collected data will also be used to apply for regulatory approval in France by HAS (Haute Autorit de Sant).

Detailed Study Description

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.

Clinical Study Identifier: NCT03192813

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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