The EMPOWER Trial - The Carillon Mitral Contour System® in Treating Heart Failure With FMR (NCT03142152) | Clinical Trial Compass
RecruitingNot Applicable
The EMPOWER Trial - The Carillon Mitral Contour System® in Treating Heart Failure With FMR
United States300 participantsStarted 2018-01-01
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Symptomatic heart failure with functional (secondary) mitral regurgitation of at least 1+ (mild) severity
✓. NYHA II, III, or IV
✓. Six Minute Walk distance ≥ 100 meters and ≤ 600 meters
✓. Left Ventricular Ejection Fraction ≤ 50%
✓. LVEDD:
✓. LVESD ≤ 75 mm
✓. 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.
✓. Optimal Guideline directed heart failure medical therapy assessed by the Central Review Committee
Exclusion criteria
✕. Presence of a mechanical or bio-prosthetic mitral valve or, mitral valve annuloplasty, or leaflet repair device
✕. 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)
✕. Severe tricuspid regurgitation associated with right ventricular dysfunction and enlargement
✕. Severe mitral annular calcification
What they're measuring
1
Primary Safety Objective - Freedom from Major Adverse Events
✕. Expected to require any cardiac surgery, including surgery for coronary artery disease (CAD) or valve disease within one (1) year
✕. 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