The ENCIRCLE Trial (NCT04153292) | Clinical Trial Compass
RecruitingNot Applicable
The ENCIRCLE Trial
United States900 participantsStarted 2020-11-12
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 18 years of age or older
✓. MR ≥ 3+
✓. NYHA functional class ≥ II
✓. Per the Heart Team, commercially available surgical or transcatheter treatment options are deemed unsuitable due to clinical, anatomic or technical considerations.
✓. 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.
✓. 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.
Exclusion criteria
✕. Mitral/cardiac anatomy that would preclude appropriate delivery and deployment of the SAPIEN M3 dock or valve
✕. Inappropriate anatomy for femoral introduction and delivery of the SAPIEN M3 dock and valve
✕. Presence of any device that will contact or interfere with the SAPIEN M3 System during delivery or after implantation
✕. Left ventricular ejection fraction \<25%
✕. Severe right ventricular dysfunction
✕. Need for aortic, tricuspid or pulmonic valve intervention within the next 12 months
What they're measuring
1
Non-hierarchical composite of death and heart failure rehospitalization