The ENCIRCLE Trial
Research type
Research Study
Full title
SAPIEN M3 System TransCatheter Mitral Valve Replacement via TransseptaL Access
IRAS ID
292443
Contact name
Simon Redwood
Contact email
Sponsor organisation
Edwards Lifesciences LLC
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
6 years, 6 months, 10 days
Research summary
Mitral regurgitation (MR) is the most frequent valve disease in the US and the second most common form of valvular heart disease requiring surgery in Europe.
MR is classified as either primary or secondary. In primary MR (also known as organic or degenerative), there is an abnormality in one or more components of the mitral apparatus (leaflets, annulus, chordae tendineae, papillary muscles).
In secondary MR (also known as functional), the valve itself is usually normal and mitral insufficiency arises from alterations in left ventricular (LV) geometry.
The objective of this study is to establish the safety and effectiveness of the SAPIEN M3 System (which includes the SAPIEN M3 valve and the SAPIEN M3 dock) in adult subjects with symptomatic, at least 3+ MR for whom commercially available surgical or transcatheter treatment options are deemed unsuitable due to clinical, anatomic or technical considerations. The SAPIEN M3 dock and valve (size 29mm) are being implanted via transcatheter access.
The study will be conducted at up to 65 sites in North America, Europe and Australia and is expected to last up to 7 years. Participants will undergo medical assessments at the following intervals: screening, procedure (implant of the SAPIEN M3 dock and valve), post-procedure, discharge, 30 days, 6 months, 1 year and annually through 5 years.REC name
London - Dulwich Research Ethics Committee
REC reference
21/LO/0381
Date of REC Opinion
22 Jul 2021
REC opinion
Further Information Favourable Opinion