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

Launched by CARDIAC DIMENSIONS, INC. · May 3, 2017

Keywords

ClinConnect Summary

The EMPOWER Trial is studying a new treatment option for patients with heart failure who also have a condition called functional mitral regurgitation (FMR). FMR occurs when the heart's mitral valve doesn't close properly, causing blood to flow backward and making the heart work harder. The trial is evaluating the safety and effectiveness of the Carillon Mitral Contour System, which aims to improve heart function and relieve symptoms for those affected by FMR.

To participate in this trial, patients should be between the ages of 65 and 74 and have been diagnosed with heart failure. They should also have symptoms related to FMR, be able to walk a certain distance, and meet specific heart function criteria. Participants will receive close monitoring and care throughout the study, and their experiences will help researchers understand if this new treatment can make a difference for others with similar heart issues. If you or a loved one is interested in learning more, please discuss it with your healthcare provider.

Gender

ALL

Eligibility criteria

• 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