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

Recruiting now · Not applicable

Conditions studied: Functional Mitral Regurgitation, Heart Failure, Mitral Valve Insufficiency, Heart Diseases, Cardiovascular Diseases, Heart Valve Diseases

In brief

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).

Key facts

Study ID

NCT03142152

Run by

Cardiac Dimensions, Inc.

People needed

300

Starts

2018-01-01

Expected to finish

2030-12-31

Last updated by the study team

2026-04-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• Severe aortic stenosis
• 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

Where it is running

• St Elizabeth's Medical Center — Boston, Massachusetts, United States (enrolling)
• St. Louis Heart and Vascular — St Louis, Missouri, United States (enrolling)
• Community Health Network — Indianapolis, Indiana, United States (enrolling)
• Johns Hopkins — Baltimore, Maryland, United States (enrolling)
• Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
• CentraCare Heart and Vascular — Saint Cloud, Minnesota, United States (enrolling)
• Tucson Medical Center Health — Tucson, Arizona, United States (enrolling)
• Banner Health - Phoenix — Phoenix, Arizona, United States (enrolling)
• Banner University Tuscon — Tucson, Arizona, United States (enrolling)
• Ochsner Health System — New Orleans, Louisiana, United States (enrolling)
• South Denver Cardiology — Littleton, Colorado, United States (enrolling)
• Dignity Health Research Institute at Mercy Gilbert and Chandler Regional Medical Centers — Gilbert, Arizona, United States (enrolling)
• Keck School of Medicine of USC — Los Angeles, California, United States (enrolling)
• Beth Israel Deaconess — Boston, Massachusetts, United States (enrolling)
• UCLA Medical Center — Los Angeles, California, United States (enrolling)
• Advent Health Hospital — Orlando, Florida, United States (enrolling)
• Palm Beach Gardens Medical — Palm Beach, Florida, United States (enrolling)
• Stanford University — Redwood City, California, United States (enrolling)
• Tampa General Hospital — Tampa, Florida, United States (enrolling)
• Scripps Health — San Diego, California, United States (enrolling)
• University of California- San Francisco — San Francisco, California, United States (enrolling)
• Cardiovascular Institute South — Houma, Louisiana, United States (enrolling)
• Advocate Good Samaritan — Downers Grove, Illinois, United States (enrolling)
• Midwest Cardiovascular Institute (MCI) — Naperville, Illinois, United States (enrolling)
• Deborah Heart & Lung — Browns Mills, New Jersey, United States (enrolling)

Full record on ClinicalTrials.gov

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