Reduction of Mitral Regurgitation With the SATURN Trans-Septal Transcatheter Mitral Valve Replacement (TMVR) System in Patients With Severe Symptomatic Mitral Regurgitation

Inclusion criteria

• Age 65 years or older.
• Symptomatic moderate to severe or severe functional 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

• General Exclusion Criteria
• Degenerative (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 year 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 \> 60mmHg.
• Platelets \< 90,000.
• COPD 2 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" 3 .
• 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 or ICD implanted in previous 30 days.
• Cardiogenic shock, hemodynamic instability, Systolic Blood Pressure \<90mmHg, Inotropic dependent or requiring 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 congestive heart failure:
• Patients with ascites.
• 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.
• Contraindications to TEE imaging
• Cardiac Imaging Exclusion Criteria
• 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 TS Bioprosthetic System or SATURN TS procedure as determined by the Screening Committee.