Bio Refine for Functional Mitral Regurgitation - a Safety & Feasibility Study
The purpose of this study is to evaluate the safety and feasibility of the Bio Refine Coriofix System and determine if it might help in treatment of functional mitral regurgitation. The study will include patients with symptomatic secondary mitral regurgitation in whom mitral surgery cannot and/or will not be offered as a treatment option (the risk is prohibitive). Potential patients will be screened to confirm that all inclusion/exclusion criteria are met, with final eligibility confirmation on day of procedure. All enrolled subjects who went through the procedure will be followed during the procedure to hospital discharge. Additional follow up time points are scheduled at 30 days, 6 months and 12 months post procedure.
• Local heart team has determined that mitral valve surgery will not be offered as a treatment option
• Symptomatic secondary mitral regurgitation (3+ or 4+)
• Adequately treated in compliance with optimal guideline-directed medical therapy for heart failure for at least 90 days
• NYHA functional class II, III or ambulatory IV
• LVEF ≥30%.
• Written informed consent has been obtained