SCOPE 1 Trial
Research type
Research Study
Full title
Safety and efficacy of the Symetis ACURATE neo/TF compared to the Edwards SAPIEN 3 bioprosthesis for transcatheter aortic valve implantation by transfemoral approach
IRAS ID
217116
Contact name
Simon Redwood
Contact email
Sponsor organisation
University of Bern
Duration of Study in the UK
4 years, 5 months, 1 days
Research summary
Transcatheter aortic valve implantation (TAVI) is an established treatment option for patients with severe symptomatic aortic stenosis and at high risk for surgical aortic valve replacement. The use of TAVI is rapidly expanding worldwide and the indications for TAVI are widening into lower risk populations in view of favorable outcomes among intermediate and high risk pateitns, changes to address limitations, such as vascular access complications, paravalvular (leak around the outside of the valve) regurgitation, and electrical disturbances. However, device comparisons by use of randomized trials are scarce.\nThe SCOPE-trial will compare the performance of the Symetis ACURATE Neo self expanding device to the balloon-expandable Edwards SAPIEN 3 which is a widely used and well-established transcatheter heart valve of the second generation, in a randomized fashion.\n\n\nParticipants will be recruited at sites that are already using both these devices as part of their routine standard of care. Each participant will be followed up for 3 years in order to answer the primary and secondary objectives. There are no addition invasive tests required for this study. Additional procedures include completing 2 quality of life questionnaires, stroke scale assessment and completing 6 minute walk tests at a number of time points throughout the study.\n
REC name
London - Bloomsbury Research Ethics Committee
REC reference
17/LO/1246
Date of REC Opinion
9 Aug 2017
REC opinion
Favourable Opinion