Bio Refine for Functional Mitral Regurgitation - a Safety & Feasibility Study

Inclusion criteria

• 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

Exclusion criteria

• Untreated clinically significant coronary artery disease requiring revascularization.
• CABG, PCI or TAVR within the prior 90 days.
• Aortic or tricuspid valve disease requiring surgery or transcatheter intervention or severe tricuspid regurgitation.
• COPD requiring continuous home oxygen therapy or chronic outpatient oral steroid use.
• CVA or TIA within prior 180 days.
• Hypotension
• Any history of ventricular arrythmia
• Patients implanted with any kind of CIED
• Life expectancy <12 months due to non-cardiac conditions
• Prior mitral valve leaflet surgery or any currently implanted prosthetic mitral valve, or any prior transcatheter mitral valve procedure
• TEE is contraindicated or high risk
• Pregnant or planning pregnancy within next 12 months
• Currently participating in an investigational drug or another device study that has not reached its primary endpoint