SATURN Transcatheter Mitral Valve Replacement for Functional Mitral Regurgitation

Exclusion Criteria

• •1. Excessive frailty or comorbid conditions that preclude the anticipated benefit of the valve replacement.
• •2. Life expectancy \<1 yr due to noncardiac conditions.
• •3. Active endocarditis.
• •4. Active systemic infection.
• •5. Modified Rankin Scale ≥4 disability.
• •6. Hemodialysis/ chronic renal failure (eGFR \< 35 mL/min/m2).
• •7. Pulmonary arterial hypertension (fixed PAS \< 60mmHg). 8) COPD on home oxygen.
• •9\) Refuses blood transfusions. 10) Documented bleeding or coagulation conditions (hypo- or hyper-coagulable states).
• •11\) Severe connective tissue disease under chronic immunosuppressive or cortisone therapy.
• •12\) Pregnant/ lactating. Females of childbearing age must be willing to take contraceptives.
• •13\) Participating in other investigational studies likely to confound the results or affect the study.
• •14\) Unable to consent. 15) Unable or unwilling to comply with study Follow-up. 16) Patients classified as "vulnerable patients".
• •1. Myocardial infarction during prior 30 days.
• •2. Stroke or TIA during prior 30 days.
• •3. Severe extracardiac arteriopathy (safety measure for extra-circulatory support if surgical conversion is needed).
• •4. Prior mitral valve treatment (e.g. valve repair or replacement, MitraClip, etc.), and/or anticipated mitral valve treatment prior to enrollment.
• •5. Prior surgical mechanical valve AVR.
• •6. Prior TAVI.
• •7. Need for any cardiovascular surgery or intervention (other than for MV disease) within 30 days.
• •8. CRT or ICD implanted in previous 30 days.
• •9. Cardiogenic shock, hemodynamic instability, Systolic Blood Pressure \<90mmHg, Inotropic dependent or IABP/mechanical circulatory support.
• •10. CABG or PCI within previous 30 days.
• •11. Adequately treated for cardiac condition per applicable standards, such as for coronary artery disease, left ventricular dysfunction, mitral regurgitation, or heart failure. No need for revascularization.
• •12. Prior or planned heart transplantation (UNOS status 1).
• •13. Physical evidence of right-sided congestive heart failure:
• •1. Patients with ascites.
• •2. Patients with anasarca (generalized edema / hydropsy).
• •14. Chest condition that prevents transapical access.
• •15. Known hypersensitivity or contraindication to procedural or post-procedural medication (e.g., contrast solution, anticoagulation therapy).
• •16. Documented hypersensitivity to nickel or titanium.
• •1. Left ventricular EF ≤ 30% by imaging.
• •2. Severe mitral annular calcification, severe mitral stenosis, valvular vegetation or mass.
• •3. Extensive mitral flail leaflets.
• •4. Left ventricular thrombus, mass, or vegetation.
• •5. Left ventricular end-diastolic diameter \> 7.5 cm.
• •6. Severe right ventricular dysfunction.
• •7. Significant intracardiac shunt.
• •8. Anatomic ineligibility for SATURN valve as determined by the Screening Committee.