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

The purpose of this early feasibility study (EFS) is to evaluate the safety and performance of the CARLEN System in patients with symptomatic, moderate-to-severe or severe (MR ≥ 3+), functional (or secondary) mitral 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