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The EMPOWER Trial: Carillon Mitral Contour System for Heart Failure with Functional Mitral Regurgitation

This study is looking at a device called the Carillon Mitral Contour System® to treat heart failure when it's caused by functional mitral regurgitation (FMR). FMR is when your heart's mitral valve doesn't close properly, leading to blood leaking backward. The Carillon implant is designed to reshape the mitral valve to reduce this leakage. Researchers want to see if this device is safe and effective when compared to standard heart failure medications. You might be able to join if you have symptomatic heart failure with at least mild FMR, are between 18 and 600 meters on a 6-minute walk test, and have specific heart measurements. The study aims to enroll 300 participants, but its current recruitment status is unclear.

Study design
This is a randomized, double-blinded (you and the assessors won't know which group you're in), sham-controlled study involving 300 participants. Participants will be assigned by chance to either receive the Carillon implant or a sham procedure.
What's involved
You will undergo a heart ultrasound and a coronary angiogram to check if you meet the study's requirements. If eligible, you will be randomized to either receive the Carillon implant or a sham procedure.
Compensation
Not stated in the trial record.
Follow-up
The study will track your safety for 12 months and your overall clinical progress for 24 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03142152

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

Recruiting
NAAges 18+InterventionalTreatment
Cardiac Dimensions, Inc.
~300 participants
Updated 2026-04-13 on ClinicalTrials.gov
What's tested:Carillon Mitral Contour SystemGuideline Directed Heart Failure Medication

At a glance

Recruiting sites
61 of 92 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Primary Safety Objective - Freedom from Major Adverse Events
Measured over 12 months
+1 more outcome measured

Conditions

Functional Mitral Regurgitation
Heart Failure
Mitral Valve Insufficiency
Heart Diseases
Cardiovascular Diseases
Heart Valve Diseases

Explore related trials

Functional mitral regurgitationHeart Failure

Where it's being run

92 sites across 35 states
Pennsylvania8
Florida7
California6
Arizona5
Illinois5
New York5
Ohio5
Virginia5

Study leadership

  • Samir Kapadia, MD · PRINCIPAL_INVESTIGATOR · The Cleveland Clinic
  • Randall Starling, MD · PRINCIPAL_INVESTIGATOR · The Cleveland Clinic

Who to contact

Hank Hauser
[email protected]
(310) 228-0016
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

≥ 55 mm (women)
≥ 57 mm (men) 6. LVESD ≤ 75 mm 7. 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. 8. Optimal Guideline directed heart failure medical therapy assessed by the Central Review Committee 9. Age ≥ 18 years old 10. Carillon implant can be sized and placed in accordance with the IFU 11. 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

An entire list of eligibility is available in the clinical investigational plan

What this trial measures

  • Primary Safety Objective - Freedom from Major Adverse Events12 months

    Freedom from a composite of major adverse events (defined as Device Embolization, Vessel Erosion, Cardiac Perforation, and occurrence of cardiac surgery or percutaneous coronary intervention) in the Intervention group is greater than performance goal of 90%.

  • Primary Efficacy Objective 1 - Hierarchical Clinical Composite24 months

    To demonstrate that the CMCS (Intervention) group is superior to the Control group on the hierarchical composite endpoint of death, Cardiac transplantation or LVAD implantation, unplanned percutaneous or surgical mitral valve intervention, unplanned heart failure hospitalization, change in KCCQ overall summary score, and change in six-minute walk distance at 24 months (analyzed when the last subject completes 12 months of follow-up.)