The SURPASS Study #2017-15
Research type
Research Study
Full title
The SURPASS Study: Post-Market Study to evalUate Real-world outcomes and treatment Practices for the CENTERA™ TranScatheter Heart Valve System.
IRAS ID
246772
Contact name
Joseph Mills
Contact email
Sponsor organisation
Edwards Lifesciences LLC
Duration of Study in the UK
0 years, 11 months, 25 days
Research summary
Aortic Stenosis is one of the commonest forms of vascular disease in developed countries, and left un-treated leads to debilitation and can be life threatening. Progressive calcification of the valve causes reduced blood flow through the heart and in time, results in various symptoms including angina, syncope and/or heart failure.
Treatment options for patients with severe, symptomatic AS who are considered to be at intermediate, high or extreme risk for surgical aortic valve replacement (SAVR) can receive treatment by using medical management only, by a percutaneous balloon aortic valvuloplasty (BAV) or by transcatheter aortic valve implantation (TAVI).
The objective of this study is to evaluate real-world outcomes and treatment practices for the Edwards CENTERA self-expanding transcatheter heart valve (THV) system as part of the subjects standard of care during TAVI.
The study will be mainly be conducted in Europe and will recruit 400 subjects in total over up to 40 sites. Each subject will undergo standard of care treatment with the device and then be followed up after the procedure for 30 days.REC name
London - Stanmore Research Ethics Committee
REC reference
18/LO/2140
Date of REC Opinion
1 Feb 2019
REC opinion
Further Information Favourable Opinion