Evolut R FORWARD
Research type
Research Study
Full title
A prospective single arm study to document the clinical and device performance outcomes of the Evolute R system for the treatment of aortic valve stenosis
IRAS ID
194752
Contact name
Ganesh Manoharan
Contact email
Sponsor organisation
Medtronic
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
, 16/NI/0034
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
The Evolut-R Forward study: is a prospective single arm, multi-centre, observational post market study looking at the clinical and device performance outcomes of the Evolut-R Transcatheter Aortic Valve Implantation system used in routine hospital practice for aortic valve stenosis or valve failure.
Approximately 1000 patients will be enrolled over a period of 12 to 18 months and followed up for 3 years after surgery, the study is expected to run up to 5 years.Transcaheter aortic valve implantation (TAVI) has become a routine treatment option at specialized heart centres treating patients with severe aortic stenosis (a narrowing of the aortic valve thus restricting blood flow to the valve). While there has been significant improvements in TAVI outcomes due to better patient selection, some important issues related to procedural complications still remain.
This research study will aim to observe the Evolut R aortic valve and the Evolute R system which has been developed from the already commercially available Corevalve system in order to prevent some of the procedural complications that still remain. The research is part of standard of care and will look at the safety and efficacy of the Evolute R system in a large cohort of patients.
REC name
HSC REC B
REC reference
16/NI/0034
Date of REC Opinion
30 Mar 2016
REC opinion
Further Information Favourable Opinion