Safety and performance evaluation of the CARLEN System in patients with functional mitral valve regurgitation.
Age > 21 years at time of enrollment
Patient has provided informed consent, is willing and capable of participating in all testing, and agrees to return for all required post-procedure follow-up visits
Moderate-to-severe or severe (MR ≥ 3+) functional (secondary) mitral valve regurgitation
Symptomatic with mitral regurgitation (NYHA Class II, III, or ambulatory IV) despite maximally-tolerated guideline-directed medical therapy (GDMT) as determined by the local multidisciplinary Heart Team
Estimated life expectancy of less than 12 months
Women who are pregnant, lactating, or planning to become pregnant during the clinical study. Women of child-bearing potential must have negative pregnancy test result within 2 weeks prior to the procedure
Left Ventricular Ejection Fraction (LVEF) < 20%
Left ventricular end diastolic diameter (LVEDD) > 75 mm