RecruitingMitral RegurgitationMitral Valve Insufficiency

The ENCIRCLE Trial

Eligible age

18+ yrs

Accepts

All genders

Locations

29 states

Healthy volunteers

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About this study

This study will establish the safety and effectiveness of the SAPIEN M3 System in subjects with symptomatic, at least 3+ mitral regurgitation (MR) for whom commercially available surgical or transcatheter treatment options are deemed unsuitable. Following completion of enrollment, subjects will be eligible for enrollment in the continued access phase of the trial.

Sponsor: Edwards Lifesciences

You may qualify if…

✓ 1. 18 years of age or older
✓ 2. MR ≥ 3+
✓ 3. NYHA functional class ≥ II
✓ 4. Per the Heart Team, commercially available surgical or transcatheter treatment options are deemed unsuitable due to clinical, anatomic or technical considerations.
✓ 5. Subject's heart failure management has been optimized based on subject characteristics and applicable guidelines, and stable for at least 30 days prior to enrollment.
✓ 6. The subject or subject's legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.

You may not qualify if…

✕ 1. Mitral/cardiac anatomy that would preclude appropriate delivery and deployment of the SAPIEN M3 dock or valve
✕ 2. Inappropriate anatomy for femoral introduction and delivery of the SAPIEN M3 dock and valve
✕ 3. Presence of any device that will contact or interfere with the SAPIEN M3 System during delivery or after implantation
✕ 4. Left ventricular ejection fraction \<25%
✕ 5. Severe right ventricular dysfunction
✕ 6. Need for aortic, tricuspid or pulmonic valve intervention within the next 12 months
✕ 7. History of heart transplant
✕ 8. Cardiac imaging evidence of intracardiac mass, thrombus or vegetation