SCOPE II
Research type
Research Study
Full title
Safety and efficacy Comparison Of two TAVI systems in a Prospective randomized Evaluation II:\nA 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.\n
IRAS ID
226980
Contact name
Philip URBAN
Contact email
Sponsor organisation
CERIC
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
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. \nThe Symetis ACURATE neoTM, a self-expanding transcatheter valve delivered via transfemoral access, is a second-generation device that gained CE mark approval in June 2014. Medtronic CoreValve Evolut R Transcatheter Aortic Valve Implantation (TAVI) System is also a CE-marked transcatheter valve and is the most widely used self-expanding transcatheter valve from the second generation.\nThe two transcatheter aortic valve systems have regulatory and marketing. The devices are commercially available in UK and routinely used in current practice. \n\nThe two transcatheter aortic valve systems will be taken off the shelf at the participating site. \n\nThe SCOPE-II trial will compare, within current guidelines and Insruction For Use, the safety and performance of the Symetis ACURATE neoTM with the self-expanding Medtronic Evolut R system. \nThe procedure and the clinical follow up are the same as for any other TAVI procedure. The difference of participating in the study is that some medical data will be collected and analyzed.\nBefore the procedure, as per standard of care, patient will be required to undergo a physical medical examination, and a routine blood test. The disease grade will be documented by TransThoracic Echocardiogram (TTE), Electrocardiogram, Computed Tomography scanner, Coronary catheterization, and lower extremity arteriogram. \nAt the occasion of the 30-day and 1-year follow-up visit, patient will undergo TTE and ECG examination. The total duration of their participation in the study follow-up period will be 1 year.\n\n
REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
17/LO/1363
Date of REC Opinion
23 Oct 2017
REC opinion
Further Information Favourable Opinion