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

Summary

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).

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:

   * ≥ 55 mm (women)
   * ≥ 57 mm (men)
6. LVESD ≤ 75 mm
7. Corrected NT-proBNP \> 1200 pg/ml measured within 60 days of randomization, and/or one or more heart failure hospitalizations within one year prior to consent or one or more outpatient visits for intensification of heart failure therapy within one year prior to consent.
8. Optimal Guideline directed heart failure medical therapy assessed by the Central Review Committee
9. Age ≥ 18 years old
10. Carillon implant can be sized and placed in accordance with the IFU
11. 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. 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

Conditions7

Locations75 sites

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