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

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