Inclusion Criteria:
- Age 18 years or older.
- Symptomatic, moderate to severe or severe, functional or mixed, mitral regurgitation (≥ Grade 3+).
- NYHA functional Class ≥ II. If Class IV, patient must be ambulatory.
- Ability to tolerate oral anticoagulation.
- Ability to qualify for bailout surgery (which may include open heart surgery).
- High risk for open-heart mitral valve surgery due to age, co-morbidities or frailty, as determined by the Heart Team.
- Willing and able to complete study-related assessments and questionnaires.
Exclusion Criteria:
- Purely degenerative (organic/primary) (i.e. intrinsic valve lesions) mitral regurgitation.
- Excessive frailty or comorbid conditions that preclude the anticipated benefit of the mitral valve replacement.
- Life expectancy <1 yr. due to noncardiac conditions.
- Endocarditis in the 3 months prior to procedure date.
- Current admission with acute heart failure exacerbation.
- Dependency on inotropic agents or mechanical circulatory support.
- Untreated clinically significant CAD.
- Active systemic infection.
- Modified Rankin Scale ≥4 disability.
- Chronic renal failure defined as eGFR < 30 mL/min/m2 or on renal replacement therapy.
- Severe pulmonary arterial hypertension (PAH), defined as PASP > 70mmHg.
- Platelets < 90,000.
- COPD on home oxygen therapy deemed too high risk for intubation.
- Refuses blood transfusions.
- Documented bleeding or coagulation disorders (hypo- or hyper-coagulable states).
- Severe connective tissue disease under chronic immunosuppressive or cortisone therapy.
- Participating in other investigational studies likely to confound the results or affect the study.
- Unable or does not sign the study informed consent form.
- Patients classified as "vulnerable patients"
Cardiovascular Exclusion Criteria
- Myocardial infarction during prior 30 days.
- Stroke or TIA during prior 90 days.
- Severe extracardiac arteriopathy (safety measure for extra-circulatory support if surgical conversion is needed).
- Prior mitral valve treatment (e.g., valve repair or replacement, MitraClip, etc.), and/or anticipated mitral valve treatment prior to enrollment.
- Prior surgical mechanical valve AVR.
- Prior TAVI. -Need for any planned cardiovascular surgery or intervention (other than for MV disease) within 30 days post-index procedure.
- CRT, CRT-D, IPG or ICD implanted in previous 30 days.
- Cardiogenic shock, hemodynamic instability, Systolic Blood Pressure <90mmHg, Inotropic dependent or IABP/mechanical circulatory support.
CABG or PCI within previous 30 days.
- Inadequately treated for cardiac condition per applicable standards, such as for coronary artery disease, left ventricular dysfunction, mitral regurgitation, or heart failure, as reviewed by the Patient Screening Committee.
- Prior or planned heart transplantation (UNOS status 1).
- Physical evidence of right-sided CHF:
1. Patients with ascites.
2. Patients with anasarca (generalized edema / hydropsy).
- Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or other structural heart disease causing heart failure with the exception of dilated ischemic or non-ischemic cardiomyopathy.
Procedural Exclusion Criteria
- Known hypersensitivity or contraindication to procedural or post-procedural medication (e.g., contrast solution, anticoagulation therapy).
- Documented hypersensitivity to nickel or titanium.
Cardiac Imaging Exclusion Criteria (evaluated by Core Labs)
- Contraindications to TEE imaging
- Left ventricular EF ≤ 30% by echocardiogram.
- Severe mitral annular calcification, severe mitral stenosis, valvular vegetation or mass.
- Extensive mitral flail leaflets
- Evidence of new or untreated intracardiac thrombus, mass, or vegetation.
- Severe right ventricular dysfunction.
- Severe tricuspid regurgitation.
- Hemodynamically significant inter-atrial shunt (ASD).
- Severe aortic regurgitation or aortic stenosis.
- Anatomic ineligibility for SATURN Valve or SATURN TS procedure as determined by the Screening Committee.