Beating Heart Mitral Valve Repair With the HARPOON™ System

Exclusion Criteria

• •Patients will be excluded if ANY of the following criteria apply:
• •1. Functional mitral regurgitation (FMR).
• •2. Evidence of anterior or bileaflet prolapse.
• •3. Severe mitral annular calcification (MAC).
• •4. Moderate or greater leaflet calcification.
• •5. Fragile or thinning apex (e.g. LV aneurysm).
• •6. Have undergone cardiac or peripheral vascular procedures within 30 days prior to the trial procedure.
• •7. Planned cardiac or peripheral vascular procedures within 30 days after the trial procedure.
• •8. Requirement for concomitant cardiac surgery.
• •9. Severe pulmonary hypertension (pulmonary artery systolic pressure \> 60mmHg).
• •10. Severe aortic stenosis or insufficiency.
• •11. Severe tricuspid regurgitation. (Patients with mild or moderate tricuspid regurgitation are not excluded.)
• •12. Left ventricular ejection fraction (LVEF) \<30%, or severely impaired right ventricular dysfunction as measured by the core lab.
• •13. Any history of endocarditis.
• •14. Contraindication to cardiac surgery, including hostile chest or history of mediastinal radiation.
• •15. Previous structural heart intervention (e.g. any heart valve replacement or repair procedures). Previous percutaneous coronary intervention (PCI) is allowed.
• •16. Previous coronary artery bypass grafting (CABG).
• •17. Stroke within 30 days prior to index procedure.
• •18. ST segment elevation myocardial infarction (STEMI) requiring intervention within 30 days prior to index procedure.
• •19. Evidence of cirrhosis or hepatic synthetic failure (Child-Pugh Class B or higher, \[or MELD score of ≥ 13\]).
• •20. Renal insufficiency CKD Stage 3b or worse (GFR \< 45 ml/min/1.73 m2).
• •21. Hemodynamic instability or cardiogenic shock at the time of enrollment (e.g. requiring inotropic support or mechanical support devices).
• •22. History of bleeding diathesis or coagulopathy or leukopenia (WBC \< 3000 mcL) or acute anemia (Hb \< 9 g/dL) or thrombocytopenia (platelets \< 50,000 cells mcL).
• •23. Active SARS-CoV-2 infection (Coronavirus-19 \[COVID-19\]) or previously diagnosed with COVID-19 with sequelae that could confound endpoint assessments (as assessed by Case Review Committee).
• •24. Refuse blood products.
• •25. Planned treatment with any other investigational device or procedure through 1-year follow-up, or who are currently participating in an investigational drug or device trial.
• •26. Carotid stenosis ≥ to 80% at time of enrollment.
• •27. Rheumatic heart disease including rheumatic mitral stenosis.
• •28. Pregnant or lactating at the time of enrollment (women of childbearing age should have negative pregnancy test within 72 hours of surgery) or planning pregnancy within the next 12 months.
• •29. Concurrent medical condition with a life expectancy of less than 12 months in the judgment of the Investigator.
• •30. Condition or conditions that, in the opinion of the Investigator, precludes participation, including willingness to comply with all follow-up procedures.
• •31. Contraindication for transesophageal echocardiography (TEE), including esophageal spasm, esophageal stricture, esophageal laceration, esophageal perforation, esophageal diverticula (e.g. Zenker's diverticulum).
• •32. Echocardiographic evidence of intracardiac mass (e.g. left ventricular, atrial, or appendage thrombus, myxoma, or vegetation).
• •33. Cannot tolerate procedural anticoagulation or post-procedure antiplatelet regimen.
• •34. No longer meets eligibility criteria based on intra-operative assessment.