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