Early Feasibility Study (EFS) of the Nyra Cardiac Leaflet Enhancer (CARLEN) System

Safety and performance evaluation of the CARLEN System in patients with functional mitral valve regurgitation.

Key Inclusion Criteria: * 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 * Patient is suitable for transcatheter mitral valve repair as determined by the local multidisciplinary Heart Team and confirmed by the Eligibility Committee Key Exclusion Criteria: * 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 * Acute hemodynamic decompensation * Known hypersensitivity or contraindications to necessary and routine medications including contrast compounds or components used in the CARLEN System that cannot be successfully pre-medicated, including nitinol, an alloy of nickel and titanium * Contraindicated for transesophageal echo (TEE) * Presence of other anatomical characteristics and/or significant comorbidities that in the judgement of the Investigator or Eligibility Committee precludes the subject from participation * Aortic valve disease requiring intervention or intervention * Severe or greater tricuspid regurgitation * Severe right ventricular dysfunction * Severe pulmonary hypertension * Presence of significant congenital heart disease * Planned or scheduled cardiac surgery within next 12 months * Endocarditis within last 90 days * Evidence of intracardiac mass, vegetation, or inflammatory or infectious valve disease