Reduction of Mitral Regurgitation With the SATURN Trans-Septal Transcatheter Mitral Valve Replacement (TMVR) System in Patients With Severe Symptomatic Mitral Regurgitation
Trial Parameters
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Brief Summary
The goal of this clinical trial is to evaluate feasibility, safety, and performance of the SATURN TS TMVR System for the treatment of moderate-to-severe or severe, symptomatic mitral regurgitation through a transcatheter approach. The main questions it aims to answer are: * is the use of the device feasible? * is it safe (defined as freedom from device-related major adverse events at 30 days)? * does it perform (defined as reduction of MR Grade to ≤ 1+ at 30 days)? Participants will need to do the following as part of the clinical trial: * complete 6-Minute Walking Test * complete Quality of Life Questionnaires * undergo blood evaluations * CT scan * 12 lead ECG * Transesophageal Echocardiography * Transthoracic Echocardiogram * the study procedure (valve implantation, right heart catheterization, left arterial pressure, fluoroscopy/ angiogram)
Eligibility Criteria
Inclusion Criteria: 1. Age 65 years or older. 2. Symptomatic moderate to severe or severe functional mitral regurgitation (≥ Grade 3+). 3. NYHA functional Class ≥ II. If Class IV, patient must be ambulatory. 4. Ability to tolerate oral anticoagulation. 5. Ability to qualify for bailout surgery (which may include open heart surgery). 6. High risk for open-heart mitral valve surgery due to age, co-morbidities or frailty, as determined by the Heart Team. 7. Willing and able to complete study-related assessments and questionnaires. Exclusion Criteria: General Exclusion Criteria 1. Degenerative (i.e. intrinsic valve lesions) mitral regurgitation. 2. Excessive frailty or comorbid conditions that preclude the anticipated benefit of the mitral valve replacement. 3. Life expectancy \<1 year due to noncardiac conditions. 4. Endocarditis in the 3 months prior to procedure date. 5. Current admission with acute heart failure exacerbation. 6. Dependency on inotropic agents or mechanical circulatory