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.
InnovHeart
Lead sponsor
Avania
Collaborator