SAPIEN M3 System
Transcatheter Mitral Valve Replacement (TMVR)
The ENCIRCLE Trial
A prospective, single arm, multicenter, pivotal, adaptive design study
Trial objective
Establish the safety and effectiveness of the SAPIEN M3 system in subjects with symptomatic, at least 3+ MR for whom commercially available surgical or transcatheter treatment options are deemed unsuitable due to clinical, anatomical, or technical considerations.
Primary endpoint
Non-hierarchical composite of death & heart failure rehospitalization at 1 year.
Secondary endpoints
- Improvement in New York Heart Association (NYHA) functional class at 1 year compared to baseline
- Improvement in Kansas City Cardiomyopathy Questionnaire (KCCQ) overall score at 1 year compared to baseline
- Improvement in MR at 1 year compared to baseline
- Decrease in left ventricular end-diastolic volume index (LVEDVi) at 1 year compared to baseline
Follow-up
30 days, 6 months, 1 year, and annually through 5 years.
§Refer to Clinical Study Protocol for full enrollment criteria.
MAC, mitral annular calcification.
MR, mitral regurgitation.
TEER, transcatheter edge-to-edge repair.
The ENCIRCLE trial 1-Year Outcomes
Learn more about the SAPIEN
M3 System
Medical device for professional use
For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use (consult eifu.edwards.com where applicable).