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

Summary

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

Inclusion Criteria:

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 ≥ 57 mm and LVESD ≤ 75 mm
6. Corrected BNP of \> 300 pg/ml, or corrected NT-proBNP \> 1200 pg/ml, or one or more heart failure hospitalizations within one year prior to consent
7. Guideline directed heart failure medication regimen
8. Age 18 years old
9. Carillon implant can be sized and placed in accordance with the IFU
10. The subject has been informed of the nature of the trial and agrees to its provisions, including the possibility of randomization to the Control group and returning for all required post-procedure follow-up visits, and has provided written informed consent

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)
4. Severe tricuspid regurgitation associated with right ventricular dysfunction and enlargement
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

Conditions7

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