IRB Study Number 18-600
Status Recruiting
Location Cleveland Clinic Main Campus
Institute Heart and Vascular Institute
Description
The objective of this prospective, randomized, blinded clinical trial is to assess the safety and efficacy of the Carillon Mitral Contour System in treating heart failure with functional regurgitation (FMR)
Inclusion Criteria
- Diagnosis of ischemic or non-ischemic cardiomyopathy
- Symptomatic functional (secondary) mitral regurgitation of at least 1+ (mild) severity
- NYHA II, III, or IV
- Additional inclusion criteria will be assessed by study staff
Exclusion Criteria
- Recipient of intravenous positive-inotrope infusion or intra-aortic balloon pump support within the past 30 days
- Heart failure hospitalization within the past 30 days
- Anticipated need of left ventricular assist device within twelve (12) months
- Additional exclusion criteria will be assessed by study staff
