The EMPOWER Trial - The Carillon Mitral Contour System® in Treating Heart Failure With FMR
Key facts
- Where
- Barcelona, Madrid, and Valladolid, SpainSee the 3 sites
Where in Spain
- Hospital Clinic de BarcelonaBarcelona, SpainNot yet recruiting
- Hospital 12 de OctubreMadrid, SpainNot yet recruiting
- University Clinical Hospital of ValladolidValladolid, SpainNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Cardiac Dimensions, Inc.
- Trial code
- NCT03142152
- Record updated
- 13 April 2026
- Original description
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).Read full original descriptionShow less
Assessment of the Carillon Mitral Contour System® in Treating Heart Failure With Functional Mitral Regurgitation
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).
Inclusion: 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:; ≥ 55 mm (women); ≥ 57 mm (men); 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; Age ≥ 18 years old; Carillon implant can be sized and placed in accordance with the IFU; 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: 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); 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; An entire list of eligibility is available in the clinical investigational plan; Presence of a mechanical or bio-prosthetic mitral valve or, mitral valve annuloplasty, or leaflet repair device; Severe tricuspid regurgitation associated with right ventricular dysfunction and enlargement; Severe mitral annular calcification; Severe aortic stenosis.