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

Not Applicable

Recruiting

• Conditions: Mitral Valve Insufficiency; Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Functional Mitral Regurgitation; Heart Failure

• Registration Number: NCT03142152
• Lead Sponsor: Cardiac Dimensions, Inc.

Brief Summary

The objective of this prospective, randomized, blinded clinical trial is to assess the safety and efficacy of the Carillon Mitral Contour System in treating heart failure with functional regurgitation (FMR).

Detailed Description

A total of 300 subjects will be randomized at up to 75 investigational sites in the United States, Canada, and Europe. Subjects will be randomized into one of two study groups using a 1:1 (Intervention : Control) ratio.

Study subjects who are eligible for this clinical study will undergo a transthoracic echocardiographic examination prior to randomization to evaluate the inclusion criteria associated with the severity of mitral regurgitation. A coronary angiogram will be performed to evaluate the coronary artery anatomy and a venogram to assess the suitability of the coronary sinus/great cardiac vein (CS/GCV) for placement of the Carillon implant.

If the subject meets the anatomic requirements for device placement, the subject will be randomized. Subjects who meet all eligibility criteria will be randomized into one of two study groups (Intervention or Control).

Subjects randomized to the Intervention group will undergo the Carillon implant procedure.

Subjects randomized to the Control group will experience an index procedure similar to the Intervention group (without device placement) to ensure they will not be able to deduce the group assignment based on the type of intervention or time associated with the procedure.

After the study subjects are discharged, the subjects' primary care specialists (cardiologist/heart failure physician) and clinical investigation site staff will coordinate follow-up evaluations. Subjects will be evaluated at one (1), six (6), twelve (12), eighteen (18) and twenty-four (24) months post-randomization, to assess long-term safety, and functional and clinical status.

After the 24-month evaluation, all subjects will be unblinded. All Intervention and Control subjects will be followed with an abbreviated annual contact and echocardiogram for an additional three (3) years, for a total of five (5) years.

Study Timeline

• Study First Submitted: 2017-05-02
• Study First Submitted QC: 2017-05-03
• Study First Posted: 2017-05-05
• Study Start: 2018-01-01
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-02
• Last Update Posted: 2025-05-04
• Primary Completion: 2026-12-31
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1. Symptomatic heart failure with functional (secondary) mitral regurgitation of at least 1+ (mild) severity
2. NYHA II, III, or IV
3. Six Minute Walk distance ≥ 100 meters and ≤ 600 meters
4. Left Ventricular Ejection Fraction ≤ 50%
5. LVEDD ≥ 57 mm and LVESD ≤ 75 mm
6. Corrected BNP of > 300 pg/ml, or corrected NT-proBNP > 1200 pg/ml, or one or more heart failure hospitalizations within one year prior to consent
7. Guideline directed heart failure medication regimen
8. Age 18 years old
9. Carillon implant can be sized and placed in accordance with the IFU
10. 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 Criteria

1. Pre-existing device (e.g., pacing lead) in coronary sinus (CS) / great cardiac vein (GCV) or Class I indication for cardiac resynchronization therapy (CRT)

2. Presence of a mechanical or bio-prosthetic mitral valve or, mitral valve annuloplasty, or leaflet repair device

3. 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)

4. Severe tricuspid regurgitation associated with right ventricular dysfunction and enlargement

5. Severe mitral annular calcification

6. Severe aortic stenosis

7. Expected to require any cardiac surgery, including surgery for coronary artery disease (CAD) or valve disease within one (1) year

8. 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 judgment of the Investigator, makes the patient a poor candidate for this study

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Primary Safety Objective - Freedom from Major Adverse Events	12 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 Composite	24 months	To demonstrate that the Carillon Mitral Contour System (Intervention) group is superior to the Control group on the hierarchical composite endpoint of death, transplant or LVAD, percutaneous or surgical mitral valve intervention, heart failure hospitalization, Improvement in KCCQ, and improvement in six-minute walk distance at 24 months (analyzed when the last subject completes 12 months of follow-up.)

Secondary Outcome Measures

Name	Time	Method
Secondary Efficacy Objective 2 - Change in LV End-diastolic Volume	12 months	To demonstrate an improvement from baseline in the parameter left ventricular end-diastolic volume (LVEDV) associated with the Carillon Mitral Contour System (Intervention group) relative to the Control group.
Secondary Efficacy Objective 1- Regurgitant Volume	12 months	To compare regurgitant volume change relative to control from baseline through 12 months of follow up
Secondary Efficacy Objective 8 - Incidence of alternative therapy and all-cause mortality	12 months of follow-up, and any available data up to 24 months	To compare the incidence of need for alternative therapy and all-cause mortality (superiority test if HR \< 1), relative to Control, analyzed when the last subject completes 12 months of follow-up and use all available data up to 24 months
Secondary Efficacy Objective 9 - Total number of HFH	12 months of follow-up, and any available data up to 24 months	To compare total number of HFH, relative to Control, analyzed when the last subject completes 12 months of follow-up and use all available data up to 24 months
Secondary Efficacy Objective 3 - Change in LV End-Systolic Volume	12 months	To demonstrate an improvement from baseline in the parameter left ventricular end-systolic volume (LVESV) associated with the Carillon Mitral Contour System (Intervention group) relative to the Control group.
Secondary Efficacy Objective 4 - Change in 6 Minute Walk Distance	12 months	To demonstrate a significantly greater improvement from baseline in six-minute walk distance associated with the Carillon Mitral Contour System (Intervention group) relative to the Control group.
Secondary Efficacy Objective 5 - Change in KCCQ	12 months	To demonstrate the improvement from baseline in the overall summary score of the Kansas City Cardiomyopathy Questionnaire (KCCQ) associated with the Carillon Mitral Contour System (Intervention group) relative to the Control group.
Secondary Efficacy Objective 6 - Change in NYHA Classification	12 months	To demonstrate the improvement in the proportion of patients who improve by at least one NYHA class from baseline associated with the Carillon Mitral Contour System (Intervention group) relative to the Control group.
Secondary Efficacy Objective 7 - Percent days lost due to HFH or CV death	12 months of follow-up, and any available data up to 24 months	To compare percent days lost due to HFH and CV death, relative to Control, analyzed when the last subject completes 12 months of follow-up and use all available data up to 24 months.
Secondary Safety Objective - Freedom from peri-procedural Major Adverse Events	30 days or hospital discharge date, whichever is longer	Freedom from a composite of major adverse events (defined as Death, Myocardial Infarction, Device Embolization, Vessel Erosion, Cardiac Perforation, and occurrence of cardiac surgery or percutaneous coronary intervention) in the Intervention group is greater than 80%.

Trial Locations

Locations (69)

Dignity Health Research Institute at Mercy Gilbert and Chandler Regional Medical Centers; 🇺🇸 Gilbert, Arizona, United States

Banner Health - Phoenix; 🇺🇸 Phoenix, Arizona, United States

Tucson Medical Center Health; 🇺🇸 Tucson, Arizona, United States

Banner University Tuscon; 🇺🇸 Tucson, Arizona, United States

Memorial Care Hospital; 🇺🇸 Long Beach, California, United States

Keck School of Medicine of USC; 🇺🇸 Los Angeles, California, United States

UCLA Medical Center; 🇺🇸 Los Angeles, California, United States

Stanford University; 🇺🇸 Redwood City, California, United States

Scripps Health; 🇺🇸 San Diego, California, United States

University of California- San Francisco; 🇺🇸 San Francisco, California, United States

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