Clinical Trials

Clinical Trial Number: EMPOWER

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

Phase N/A
Physician Investigator(s)
Study Locations

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).

Eligibility Criteria

Inclusion Criteria:

  1. Diagnosis of ischemic or non-ischemic cardiomyopathy
  2. Symptomatic functional (secondary) mitral regurgitation of at least 1+ (Mild) severity Note: 4+ can only be included if multidisciplinary site assessment (including a surgeon) determines that surgery is not necessary within the 1-year follow-up period for this study.
  3. NYHA Class II, III, or IV
  4. Six Minute Walk distance ≥ 100 meters and ≤ 600 meters

  1. Left Ventricular Ejection Fraction ≤ 50%
  2. LVEDD ≥ 57 mm and LVESD ≤ 75 mm
  3. Corrected BNP of ≥ 300 pg/ml, or corrected NT-proBNP ≥ 1200 pg/ml, or one or more heart failure hospitalizations within six months prior to consent
  4. Guideline directed heart failure medication regimen.

Exclusion Criteria:

  1. Pre-existing device (e.g., pacing lead) in coronary sinus (CS) / great cardiac vein (GCV) or Class I indication for cardiac resynchronization therapy (CRT)
  2. Presence of a mechanical or bio-prosthetic mitral valve or, mitral valve annuloplasty, or leaflet repair device
  3. 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), as assessed by the Imaging Core Laboratory
  4. Severe tricuspid regurgitation associated with right ventricular dysfunction and enlargement, as assessed by the Imaging Core Laboratory
  5. Severe mitral annular calcification
  6. Severe aortic stenosis
  7. Expected to require any cardiac surgery, including surgery for coronary artery disease (CAD) or valve disease within one (1) year
  8. 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 judgment of the Investigator, makes the patient a poor candidate for this study
    • An entire list of eligibility is available in the clinical investigational plan