Edwards Cardioband System ACTIVE Pivotal Clinical Trial (ACTIVE)

The ACTIVE Trial is a prospective, randomized, multicenter trial. Patients with clinically
significant functional mitral regurgitation will be randomized 2:1 to receive either
transcatheter mitral valve repair with the Edwards Cardioband System plus guideline directed
medical therapy (GDMT) or GDMT alone. Patients will be seen for follow-up visits at
discharge, 30 days, 6 months, and annually through 5 years.

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