The EMPOWER Trial - The Carillon Mitral Contour System® in Treating Heart Failure With at Least Mild FMR
Trial Parameters
Eligibility Fast-Check
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Brief 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 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 resync