Tests a heart device for leaking mitral valve in heart failure
Tests the Carillon device in adults with heart failure and a leaking mitral valve.
Plain-language title generated from the registry record
Registry title: The EMPOWER Trial - The Carillon Mitral Contour System® in Treating Heart Failure With FMR
Key facts
- Where
- Albany, Ann Arbor, Augusta, Baltimore, Boston, Browns Mills, Buffalo, Charlottesville, Chicago, Cincinnati, Cleveland, Columbus, Danville, Dayton, Delray Beach, Downers Grove, Edison, Gilbert, Henrico, Houma, Houston, Indianapolis, Lancaster, Littleton, Long Beach, Los Angeles, Marietta, Mechanicsburg, Memphis, Miami, Milwaukee, Naperville, Nashville, New Orleans, New York, Newark, Norfolk, Orlando, Palm Beach, Philadelphia, Phoenix, Pittsburgh, Portland, Poughkeepsie, Redwood City, Richmond, Roanoke, Rochester, Royal Oak, Saginaw, Saint Cloud, Salt Lake City, San Diego, San Francisco, Sioux Falls, Springfield, St Louis, Tallahassee, Tampa, Tucson, Tulsa, Urbana, Washington D.C., and Wynnewood, United StatesSee the 75 sites
Where in United States
- Albany Medical CollegeAlbany, United StatesNo longer taking part
- University of MichiganAnn Arbor, United StatesNo longer taking part
- Augusta University Research InstituteAugusta, United StatesNo longer taking part
- Johns HopkinsBaltimore, United StatesTaking people
- Beth Israel DeaconessBoston, United StatesTaking people
- Massachusetts General HospitalBoston, United StatesTaking people
- St. Elizabeth's Medical CenterBoston, United StatesTaking people
- Deborah Heart & LungBrowns Mills, United StatesTaking people
- University at BuffaloBuffalo, United StatesTaking people
- University of Virginia Health SystemCharlottesville, United StatesNo longer taking part
- Rush University Medical CenterChicago, United StatesNo longer taking part
- Lindner Research Center at the Christ HospitalCincinnati, United StatesTaking people
- Cleveland ClinicCleveland, United StatesTaking people
- Harrington VascularCleveland, United StatesNo longer taking part
- The Ohio State UniversityColumbus, United StatesTaking people
- Geisinger Medical CenterDanville, United StatesNo longer taking part
- Kettering Health Research InstituteDayton, United StatesTaking people
- Delray Medical CenterDelray Beach, United StatesNo longer taking part
- Advocate Good SamaritanDowners Grove, United StatesTaking people
- Hackensack University Medical CenterEdison, United StatesTaking people
- Dignity Health Research Institute at Mercy Gilbert and Chandler Regional Medical CentersGilbert, United StatesTaking people
- Henrico Doctors HospitalHenrico, United StatesTaking people
- Cardiovascular Institute SouthHouma, United StatesTaking people
- Houston Healthcare Medical CenterHouston, United StatesTaking people
- Community Health NetworkIndianapolis, United StatesTaking people
- Penn Medicine Lancaster General HealthLancaster, United StatesTaking people
- South Denver CardiologyLittleton, United StatesTaking people
- Memorial Care HospitalLong Beach, United StatesNo longer taking part
- Keck School of Medicine of USCLos Angeles, United StatesTaking people
- UCLA Medical CenterLos Angeles, United StatesTaking people
- WellStar Health SystemMarietta, United StatesNo longer taking part
- UPMC Pinnacle HospitalsMechanicsburg, United StatesTaking people
- Methodist Le Bonheur HealthcareMemphis, United StatesNo longer taking part
- Baptist Hospital of MiamiMiami, United StatesNo longer taking part
- University of MiamiMiami, United StatesNo longer taking part
- Advocate Aurora Research InstituteMilwaukee, United StatesTaking people
- Midwest Cardiovascular Institute (MCI)Naperville, United StatesTaking people
- Centennial Medical CenterNashville, United StatesTaking people
- Ochsner Health SystemNew Orleans, United StatesTaking people
- Northwell Staten IslandNew York, United StatesTaking people
- St Michael/Prime Healthcare ServicesNewark, United StatesTaking people
- Sentara Norfolk General HospitalNorfolk, United StatesNo longer taking part
- Advent Health HospitalOrlando, United StatesTaking people
- Palm Beach Gardens MedicalPalm Beach, United StatesTaking people
- University of PennsylvaniaPhiladelphia, United StatesTaking people
- Thomas Jefferson UniversityPhiladelphia, United StatesNo longer taking part
- Banner Health - PhoenixPhoenix, United StatesTaking people
- AZ Heart RhythmPhoenix, United StatesNo longer taking part
- Allegheny Health NetworkPittsburgh, United StatesTaking people
- University of Pittsburgh Medical CenterPittsburgh, United StatesNo longer taking part
- Oregon Health & Science University (OHSU)Portland, United StatesTaking people
- Providence Heart InstitutePortland, United StatesTaking people
- Vassar Brothers- Hudson Valley Cardiovascular PracticePoughkeepsie, United StatesTaking people
- Stanford UniversityRedwood City, United StatesTaking people
- HCA Chippenham Medical CenterRichmond, United StatesTaking people
- Carilion HospitalRoanoke, United StatesTaking people
- Rochester Regional HospitalRochester, United StatesTaking people
- William Beaumont HospitalRoyal Oak, United StatesNo longer taking part
- Ascension St. Marys Research InstituteSaginaw, United StatesNo longer taking part
- CentraCare Heart and VascularSaint Cloud, United StatesTaking people
- Intermountain Medical CenterSalt Lake City, United StatesNo longer taking part
- Scripps HealthSan Diego, United StatesTaking people
- University of California San FranciscoSan Francisco, United StatesTaking people
- North Central Heart-AveraSioux Falls, United StatesTaking people
- Prairie Heart InstituteSpringfield, United StatesNo longer taking part
- St Louis Heart and VascularSt Louis, United StatesTaking people
- Tallahassee Research InstituteTallahassee, United StatesNo longer taking part
- Tampa General HospitalTampa, United StatesTaking people
- Banner University TusconTucson, United StatesTaking people
- Tucson Medical Center HealthTucson, United StatesTaking people
- Oklahoma Heart Institute HospitalTulsa, United StatesTaking people
- Saint Francis HospitalTulsa, United StatesTaking people
- Carle Foundation HospitalUrbana, United StatesNo longer taking part
- MedstarWashington D.C., United StatesNo longer taking part
- Lankenau Institute of Medical ResearchWynnewood, United StatesTaking people
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.