CE Mark Study for the Harpoon Medical Device

Exclusion Criteria

• •Age \< 18 years
• •Infective endocarditis
• •Anterior or bileaflet prolapse
• •Functional MR
• •History of Mediastinal Radiation
• •Inflammatory (rheumatic) valve disease
• •Requirement for concomitant cardiac surgery (e.g., coronary artery bypass grafting (CABG), aortic valve surgery, etc.)
• •Symptomatic coronary artery disease
• •Cardiogenic shock at the time of enrollment
• •ST segment elevation myocardial infarction requiring intervention within 30 days prior to enrollment
• •Evidence of cirrhosis or hepatic synthetic failure
• •Pregnancy at the time of enrollment (women of child bearing age should have negative pregnancy within 14 days of surgery)
• •Severe pulmonary hypertension (PA systolic pressure \> 70 mmHg)
• •Previous cardiac surgery, or surgery on the left pleural space
• •Left ventricular, atrial or appendage thrombus
• •Severely calcified mitral leaflets
• •Recent stroke (\< 6 months) with permanent impairment
• •EuroScore (for mitral valve repair) \> 8%
• •Patients with contraindications to Transoesophageal echocardiography
• •Severe left or right ventricular dysfunction
• •NYHA Class IV
• •Renal insufficiency CKD stage 3b or worse (GFR \< 45 ml/min/1.73 m2)
• •Patient is participating in another clinical study for which follow-up is currently ongoing. (Co-enrollment in an investigational device or interventional study)
• •Patient with non-cardiac co-morbidities and life expectancy \< 1 year
• •Patient has a condition or conditions that, in the opinion of the Investigator, preclude participation, including willingness to comply with all follow-up procedures