The ENCIRCLE Trial

Exclusion Criteria

• •1. Mitral/cardiac anatomy that would preclude appropriate delivery and deployment of the SAPIEN M3 dock or valve
• •2. Inappropriate anatomy for femoral introduction and delivery of the SAPIEN M3 dock and valve
• •3. Presence of any device that will contact or interfere with the SAPIEN M3 System during delivery or after implantation
• •4. Left ventricular ejection fraction \<25%
• •5. Severe right ventricular dysfunction
• •6. Need for aortic, tricuspid or pulmonic valve intervention within the next 12 months
• •7. History of heart transplant
• •8. Cardiac imaging evidence of intracardiac mass, thrombus or vegetation
• •9. Active bacterial endocarditis within 180 days of the procedure
• •10. Hemodynamic instability requiring inotropic or mechanical support within 30 days of the procedure
• •11. Myocardial infarction within 30 days of the procedure
• •12. Clinically significant untreated coronary artery disease requiring revascularization
• •13. Any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 30 days of the procedure
• •14. Stroke or transient ischemic attack within 90 days of the procedure
• •15. Irreversible, severe pulmonary hypertension
• •16. Chronic obstructive pulmonary disease requiring home oxygen therapy or chronic outpatient oral steroid use
• •17. Renal insufficiency or receiving renal replacement therapy
• •18. Liver disease
• •19. Planned surgery within the next 12 months
• •20. Inability to tolerate or a medical condition precluding treatment with antithrombotic therapy, including heparin administration during the procedure
• •21. Active infection requiring current antibiotic therapy
• •22. Active SARS-CoV-2 infection (Coronavirus-19 \[COVID-19\]) or previously diagnosed with COVID-19 with sequelae that could confound endpoint assessments
• •23. Leukopenia, anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy or hypercoagulable states
• •24. Refusal of blood products
• •25. Female who is pregnant or lactating
• •26. Estimated life expectancy \<12 months due to non-cardiac conditions
• •27. Participating in another investigational drug or device study that has not reached its primary endpoint
• •28. Subject considered to be part of a vulnerable population