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

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