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 atreatment option

• Symptomatic secondary mitral regurgitation (3+ or 4+)

• Adequately treated in compliance with optimal guideline-directed medical therapy forheart 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 requiringrevascularization.

• CABG, PCI or TAVR within the prior 90 days.

• Aortic or tricuspid valve disease requiring surgery or transcatheter intervention orsevere tricuspid regurgitation.

• COPD requiring continuous home oxygen therapy or chronic outpatient oral steroiduse.

• 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 mitralvalve, 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 hasnot reached its primary endpoint