CE Mark Study for the Harpoon Medical Device

Inclusion Criteria:

   - Age ≥ 18 years

   - Patient referred for mitral valve surgery

   - Presence of severe MR as read on an echocardiographic study performed within 60 days
   prior to procedure

   - Estimated post-ePTFE chordae tendineae implantation coaptation surface is adequate in
   the judgment of the operating surgeon and the patient eligibility committee

   - Degenerative mitral valve disease

   - Patient is able to sign informed consent and able to return for follow-up and is
   capable of participating in all testing associated with this clinical investigation

   - Women of child-bearing potential have a negative pregnancy test

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