Ensayos clínicos

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