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)
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.
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.
Single group
Transcatheter mitral valve replacement
DeviceThe SATURN TS TMVR System will be implanted through a transcatheter approach in patients with symptomatic mitral regurgitation.
Safety Endpoint - Freedom from Device Related Major Adverse Events
Freedom from device-related major adverse events
Technical Procedural Success Endpoint
Technical success defined as alive patient at exit from procedure room with all the following: * Successful access, delivery of the SATURN TS Bioprosthesis, and retrieval of the TS Delivery Systems * Correct positioning of the first intended SATURN TS Bioprosthesis * Freedom from emergency surgery or mitral valve re-intervention related to the device or access procedure
Efficacy Endpoint - Reduction of Mitral Regurgitation Grade to ≤ 1+
Reduction of MR Grade to ≤ 1+
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InnovHeart
Lead sponsor
Avania
Collaborator
