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

Ki vehet részt

• 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

Ki nem vehet részt

• Endocarditis in the 3 months prior to procedure date
• COPD 2 on home oxygen therapy deemed too high risk for intubation
• 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
• CRT or ICD implanted in previous 30 days
• CABG or PCI within previous 30 days
• Prior or planned heart transplantation (UNOS status 1)
• Excessive frailty or comorbid conditions that preclude the anticipated benefit of the mitral valve replacement
• Life expectancy <1 year due to noncardiac conditions
• Current admission with acute heart failure exacerbation
• Active systemic infection
• Severe pulmonary arterial hypertension (PAH), defined as PASP > 60mmHg
• Documented bleeding or coagulation disorders (hypo- or hyper-coagulable states)
• Severe connective tissue disease under chronic immunosuppressive or cortisone therapy
• Need for any planned cardiovascular surgery or intervention (other than for MV disease) within 30 days post-index procedure
• 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
• 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
• Chronic renal failure defined as eGFR <30 mL/min/m2 or on renal replacement therapy
• Platelets < 90,000
• General Exclusion Criteria
• Degenerative (i.e. intrinsic valve lesions) mitral regurgitation
• Dependency on inotropic agents or mechanical circulatory support
• Untreated clinically significant CAD
• Modified Rankin Scale ≥4 disability
• Refuses blood transfusions
• 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
• Cardiogenic shock, hemodynamic instability, Systolic Blood Pressure <90mmHg, Inotropic dependent or requiring IABP/mechanical circulatory support
• 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