Edwards CENTERA Transcatheter Heart Valve System
Research type
Research Study
Full title
Safety and Performance Study of the Edwards CENTERA Self-Expanding Transcatheter Heart Valve
IRAS ID
170092
Contact name
Mark Spence
Contact email
Sponsor organisation
Edwards Lifesciences SA
Clinicaltrials.gov Identifier
Duration of Study in the UK
6 years, 0 months, 1 days
Research summary
Research Summary
The purpose of this study is to assess the safety and device success of the Edwards CENTERA Transcatheter Heart Valve (THV) System in patients with symptomatic, severe aortic stenosis who are indicated for aortic valve replacement.
This is a non-randomized, prospective, multi-centre safety and device success study.
Up to two hundred patients are planned to be enrolled at up to 25 participating investigational centres in Europe. Patients will be assessed at the following intervals: baseline, hospital discharge, 30 days, 6 months, 1 year and annually thereafter through 5 years.
Summary of Results
A total of 247 patients were enrolled between 12 March 2015 and 28 June 2016 at 26 sites from Europe (22), Australia (3) and New Zealand (1). 198 participants were implanted with the CENTERA valve, and the average age at enrollment was 82.7 years.
The study was designed to evaluate the safety and device success of the CENTERA Transcatheter Heart Valve (THV) System in patients with symptomatic, severe aortic stenosis requiring aortic valve replacement and undergoing a TAVI procedure.
The results provide evidence that the CENTERA THV system was safe and effective for use in patients with severe aortic stenosis requiring aortic valve replacement via TAVI.
REC name
South West - Cornwall & Plymouth Research Ethics Committee
REC reference
15/SW/0215
Date of REC Opinion
9 Oct 2015
REC opinion
Further Information Favourable Opinion