Safety and Efficacy of the Percutaneous Transvenous Mitral Annuloplasty Device to Reduce Mitral Regurgitation

An Open-Label, Single-Arm Feasibility Study of the Safety and Efficacy of the Percutaneous Transvenous Mitral Annuloplasty (PTMA) Device Used to Reduce Mitral Regurgitation.

Improvement of heart failure with moderate to severe mitral regurgitation using a percutaneously delivered implanted device.

Inclusion Criteria:

• symptomatic heart failure
• moderate to severe mitral regurgitation
• 20 - 50% LVEF

Exclusion Criteria:

• mitral regurgitation of organic origins
• recent interventions
• severe comorbidities