Edwards Cardioband System ACTIVE Pivotal Clinical Trial (ACTIVE)

Inclusion Criteria: * Age \> 18 years; * Clinically Significant Functional Mitral Regurgitation (MR); * Symptomatic heart failure; * Patient hospitalized due to heart failure during 12 months prior to submission to Central Screening Committee OR elevated Brain Natriuretic Peptid (BNP); * Patient is able and willing to give informed consent and follow protocol procedures, and comply with follow-up visit compliance. Exclusion Criteria: * Primarily degenerative MR; * Mitral annular calcification that would impede implantation of device; * Other severe valve disorders requiring intervention; * Mitral valve anatomy which may preclude proper Edwards Cardioband deployment; * Life expectancy of less than twelve months; * Patient is participating in concomitant research studies of investigational products which have not reached their primary endpoint; * Unwillingness or inability to undergo follow-up investigations/visits; * Other medical, social, or psychological conditions that precludes appropriate consent and follow-up