The MITRAL II Pivotal Trial (Mitral Implantation of TRAnscatheter vaLves).

Exclusion Criteria

• •1. \- The heart team considers the patient is a surgical candidate.
• •2. \- Mitral annulus is not severely calcified.
• •3. \- Myocardial infarction requiring revascularization within 30 days from procedure.
• •4. \- Clinically significant untreated coronary artery disease requiring revascularization.
• •5. Any therapeutic invasive cardiac procedure resulting in a permanent implant that is performed within 30 days of the index procedure (unless part of planned strategy for treatment of concomitant coronary artery disease). Implantation of a permanent pacemaker is not exclusionary.
• •6. Any patient with a balloon valvuloplasty (BMV) within 30 days of the procedure (unless BMV is a bridge to ViMAC procedure after a qualifying Echo).
• •7. Severe symptomatic tricuspid regurgitation (hepatic dysfunction, ascites, edema not controlled with diuretics) requiring surgery.
• •8. Leukopenia (WBC \< 3000 cell/mL), acute anemia (Hgb \< 9 g/dL), Thrombocytopenia (Platelets \< 50,000 cell/mL), history of coagulopathy or hypercoagulable state.
• •9. Hypertrophic obstructive cardiomyopathy (HOCM) with mean LVOT gradient of ≥20 mm Hg at rest or ≥50 mmHg with Valsalva.
• •10. Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance within 30 days of screening evaluation.
• •11. Need for emergency surgery for any reason.
• •12. Severe left ventricular dysfunction with LVEF \< 20%.
• •13. Echocardiographic evidence of intracardiac mass, thrombus or vegetation.
• •14. Active upper GI bleeding within 90 days prior to procedure.
• •15. A known contraindication or hypersensitivity to all anticoagulation regimens, or inability to be anticoagulated for the study procedure.
• •16. Cardiac anatomy that would preclude appropriate delivery and deployment of an Edwards SAPIEN 3/Ultra/RESILIA valve in MAC via transseptal access, including but not limited to:
• •* Native neo mitral annulus size \< 275 mm2 or \> 810 mm2 as measured by CT scan.
• •* Significant risk of LVOT obstruction or valve embolization as assessed by CT core lab
• •17. Clinically (by neurologist) or neuroimaging confirmed stroke or transient ischemic attack (TIA) within 90 days of the procedure.
• •18. Estimated life expectancy \<12 months due to non-cardiac conditions.
• •19. Expectation that patient will not improve despite treatment of mitral valve dysfunction.
• •20. Active bacterial endocarditis within 180 days of procedure.
• •21. \- Severe right ventricular dysfunction as assessed by Echo core lab
• •22. \- Active infection requiring antibiotic therapy (subject may be a candidate after 2 weeks of antibiotic discontinuation.
• •23. \- Female who is pregnant or lactating.
• •24. \- Participating in another investigational device study.
• •25. \- Aortic valve disease requiring intervention. If aortic valve intervention is required, the AVR procedure should be performed first and if the patient remains symptomatic after AVR, may be presented for consideration for inclusion in this trial.
• •26. \- Severe fixed pulmonary hypertension (PASP ≥70 mmHg and more than 2/3 of the systemic systolic blood pressure).
• •27. \- Severe chronic obstructive pulmonary disease requiring continuous home oxygen.
• •28. \- The patient refuses mitral valve intervention
• •29. \- Recent symptomatic COVID-19 infection with residual symptoms that may affect the outcomes of this trial.