RecruitingFunctional Mitral RegurgitationHeart FailureMitral Valve Insufficiency

The EMPOWER Trial - The Carillon Mitral Contour System® in Treating Heart Failure With FMR

Eligible age

18+ yrs

Accepts

All genders

Locations

26 states

Healthy volunteers

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About this study

The objective of this prospective, randomized, double- blinded (patient and assessors), sham-controlled clinical trial is to assess the safety and efficacy of the CMCS in treating heart failure with functional regurgitation (FMR).

Sponsor: Cardiac Dimensions, Inc.

You may qualify if…

✓ 1. Symptomatic heart failure with functional (secondary) mitral regurgitation of at least 1+ (mild) severity
✓ 2. NYHA II, III, or IV
✓ 3. Six Minute Walk distance ≥ 100 meters and ≤ 600 meters
✓ 4. Left Ventricular Ejection Fraction ≤ 50%
✓ 5. LVEDD:
✓ ≥ 55 mm (women)
✓ ≥ 57 mm (men)
✓ 6. LVESD ≤ 75 mm

You may not qualify if…

✕ 1. Presence of a mechanical or bio-prosthetic mitral valve or, mitral valve annuloplasty, or leaflet repair device
✕ 2. Significant organic mitral valve pathology (e.g., moderate or severe myxomatous degeneration, with or without mitral leaflet prolapse, rheumatic disease, full or partial chordal rupture)
✕ 3. Severe tricuspid regurgitation associated with right ventricular dysfunction and enlargement
✕ 4. Severe mitral annular calcification
✕ 5. Severe aortic stenosis
✕ 6. Expected to require any cardiac surgery, including surgery for coronary artery disease (CAD) or valve disease within one (1) year
✕ 7. Chronic, severe, medical conditions or pathology, other than heart failure, that will prevent likely survival beyond twelve (12) months or any other medical condition that, in the judgement of the Investigator or Central Review Committee, makes the patient a poor candidate for this study
✕ An entire list of eligibility is available in the clinical investigational plan