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

February 27, 2024 updated by: Cardiac Dimensions, Inc.

Assessment of the Carillon Mitral Contour System® in Treating Heart Failure With at Least Mild Functional Mitral Regurgitation

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

A total of 300 subjects will be randomized at up to 75 investigational sites in the United States, Canada, Europe and Australia. 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 Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Clermont Ferrand, France
        • Not yet recruiting
        • Pôle Santé République
        • Contact:
        • Principal Investigator:
          • Janusz Lipiecki, MD
  • Greece
      • Thessaloníki, Greece
        • Recruiting
        • European Interbalkan Medical Center
        • Principal Investigator:
          • Vlasios Ninios, MD
        • Contact:
  • Poland
      • Poznan, Poland, 61-485
        • Recruiting
        • Poznan University of Medical Sciences
        • Contact:
  • United States
    • Arizona
      • Gilbert, Arizona, United States, 85297
        • Recruiting
        • Dignity Health Research Institute at Mercy Gilbert and Chandler Regional Medical Centers
        • Principal Investigator:
          • Nabil Dib, MD
        • Contact:
      • Phoenix, Arizona, United States, 85006
      • Tucson, Arizona, United States, 85724
        • Recruiting
        • Banner University Tuscon
        • Principal Investigator:
          • Arka Chatterjee, MD
        • Contact:
      • Tucson, Arizona, United States, 85712
    • California
      • Los Angeles, California, United States, 90095
      • Los Angeles, California, United States, 90033
      • San Diego, California, United States, 92037
      • San Francisco, California, United States, 94143
        • Recruiting
        • University of California- San Francisco
        • Principal Investigator:
          • Richard Cheng, MD
        • Contact:
      • Torrance, California, United States, 90502
        • Withdrawn
        • Harbor-UCLA Medical Center
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
    • Florida
      • Miami, Florida, United States, 33101
        • Recruiting
        • Baptist Hospital of Miami
        • Principal Investigator:
          • Ramon Quesada, MD
      • Naples, Florida, United States, 34102
      • Orlando, Florida, United States, 32803
      • Tallahassee, Florida, United States, 32308
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Recruiting
        • Augusta University Research Institute
        • Contact:
        • Principal Investigator:
          • Evan Hiner, MD
    • Illinois
      • Champaign, Illinois, United States, 61801
        • Withdrawn
        • Carle Foundation Hospital
      • Chicago, Illinois, United States, 60612
        • Withdrawn
        • Rush University
      • Downers Grove, Illinois, United States, 60515
      • Evanston, Illinois, United States, 60201
        • Withdrawn
        • Northshore University Health System
      • Naperville, Illinois, United States, 60540
      • Springfield, Illinois, United States, 62701
        • Active, not recruiting
        • Prairie Heart Institute
    • Indiana
      • Indianapolis, Indiana, United States, 46250
        • Recruiting
        • Community Health Network
        • Contact:
          • Brenda Newman
      • Indianapolis, Indiana, United States, 46256
      • Munster, Indiana, United States, 46321
        • Withdrawn
        • Community Healthcare System
    • Kansas
      • Wichita, Kansas, United States, 67226
    • Louisiana
      • Houma, Louisiana, United States, 70360
        • Recruiting
        • Cardiovascular Institute South
        • Principal Investigator:
          • Peter Fail, MN
        • Contact:
      • New Orleans, Louisiana, United States, 70121
        • Recruiting
        • Ochsner Health System
        • Contact:
        • Principal Investigator:
          • Stephen Jenkins, MD
    • Massachusetts
      • Boston, Massachusetts, United States, 02135
      • Boston, Massachusetts, United States, 02145
        • Recruiting
        • Massachusetts General Hospital
        • Principal Investigator:
          • Rahul Sakhuja, MD
      • Springfield, Massachusetts, United States, 01199
        • Withdrawn
        • Baystate Medical Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48859
        • Recruiting
        • University Of Michigan
        • Principal Investigator:
          • Daniel Menees, MD
        • Contact:
      • Royal Oak, Michigan, United States, 48073
        • Withdrawn
        • William Beaumont Health
      • Saginaw, Michigan, United States, 48601
        • Recruiting
        • Ascension St. Marys Research Institute
        • Principal Investigator:
          • Safwan Kassas, MD
        • Contact:
    • Minnesota
    • New Jersey
      • Browns Mills, New Jersey, United States, 08015
        • Recruiting
        • Deborah Heart & Lung
        • Contact:
        • Principal Investigator:
          • Richard Kovach
    • New York
      • Buffalo, New York, United States, 14203
      • New York, New York, United States, 10027
        • Withdrawn
        • Columbia University Medical Center
      • Poughkeepsie, New York, United States, 12601
        • Recruiting
        • Vassar Brothers- Hudson Valley Cardiovascular Practice
        • Principal Investigator:
          • Rajeev Narayan, MD
        • Contact:
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Recruiting
        • Lindner Research Center at the Christ Hospital
        • Principal Investigator:
          • Dean Kereiakes, MD
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic
        • Principal Investigator:
          • Amar Krishnaswamy, MD
        • Contact:
      • Columbus, Ohio, United States, 43210
      • Columbus, Ohio, United States, 43219
      • Dayton, Ohio, United States, 45459
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Recruiting
        • Oklahoma Heart Hospital
        • Contact:
        • Principal Investigator:
          • Mohammad Ghani, MD
    • Oregon
      • Portland, Oregon, United States, 97225
      • Portland, Oregon, United States, 97225
        • Recruiting
        • Oregon Health & Science University (OHSU)
        • Contact:
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822
        • Recruiting
        • Geisinger Medical Center
        • Principal Investigator:
          • Shikhar Agarwal, MD
      • Lancaster, Pennsylvania, United States, 17602
      • Philadelphia, Pennsylvania, United States, 19014
      • Pittsburgh, Pennsylvania, United States, 15213
        • Recruiting
        • UPMC Presbyterian
        • Principal Investigator:
          • AJ Conrad Smith, MD
        • Contact:
      • Pittsburgh, Pennsylvania, United States, 15212
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Recruiting
        • Methodist Le Bonheur Healthcare
        • Contact:
        • Principal Investigator:
          • Mehul Patel, MD
      • Nashville, Tennessee, United States, 37203
    • Texas
    • Utah
    • Virginia
      • Henrico, Virginia, United States, 23229
      • Norfolk, Virginia, United States, 23501
        • Withdrawn
        • Sentara Norfolk General
      • Roanoke, Virginia, United States, 24014
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Recruiting
        • Advocate Aurora Research Institute
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Diagnosis of ischemic or non-ischemic cardiomyopathy
  2. Symptomatic functional (secondary) mitral regurgitation of at least 1+ (Mild) severity Note: 4+ can only be included if multidisciplinary site assessment (including a surgeon) determines that surgery is not necessary within the 1-year follow-up period for this study.
  3. NYHA Class II, III, or IV
  4. Six Minute Walk distance ≥ 100 meters and ≤ 600 meters
  5. Left Ventricular Ejection Fraction ≤ 50%
  6. LVEDD ≥ 57 mm and LVESD ≤ 75 mm
  7. Corrected BNP of ≥ 300 pg/ml, or corrected NT-proBNP ≥ 1200 pg/ml, or one or more heart failure hospitalizations within six months prior to consent
  8. Guideline directed heart failure medication regimen.

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), as assessed by the Imaging Core Laboratory
  4. Severe tricuspid regurgitation associated with right ventricular dysfunction and enlargement, as assessed by the Imaging Core Laboratory
  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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
Carillon Mitral Contour System and Guideline Directed Heart Failure Medication
Other: Guideline Directed Heart Failure Medication
Heart failure medication per ACC/AHA guidelines
Device: Carillon Mitral Contour System
The Carillon implant is designed to be deployed, tensioned, and locked in the coronary vein in order to reshape the mitral annulus and thus reduce mitral annular dilation and mitral regurgitation.
Other Names:
  • Percutaneous mitral valve repair
  • Carillon
Active Comparator: Control Group
Guideline Directed Heart Failure Medication
Other: Guideline Directed Heart Failure Medication
Heart failure medication per ACC/AHA guidelines

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Safety Objective - Freedom from Major Adverse Events
Time Frame: 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%.
12 months
Primary Efficacy Objective 1 - Hierarchical Clinical Composite
Time Frame: 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.)
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary Efficacy Objective 1- Regurgitant Volume
Time Frame: 12 months
To compare regurgitant volume change relative to control from baseline through 12 months of follow up
12 months
Secondary Efficacy Objective 7 - Percent days lost due to HFH or CV death
Time Frame: 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.
12 months of follow-up, and any available data up to 24 months
Secondary Efficacy Objective 8 - Incidence of alternative therapy and all-cause mortality
Time Frame: 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
12 months of follow-up, and any available data up to 24 months
Secondary Efficacy Objective 9 - Total number of HFH
Time Frame: 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
12 months of follow-up, and any available data up to 24 months
Secondary Safety Objective - Freedom from peri-procedural Major Adverse Events
Time Frame: 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%.
30 days or hospital discharge date, whichever is longer
Secondary Efficacy Objective 2 - Change in LV End-diastolic Volume
Time Frame: 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.
12 months
Secondary Efficacy Objective 3 - Change in LV End-Systolic Volume
Time Frame: 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.
12 months
Secondary Efficacy Objective 4 - Change in 6 Minute Walk Distance
Time Frame: 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.
12 months
Secondary Efficacy Objective 5 - Change in KCCQ
Time Frame: 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.
12 months
Secondary Efficacy Objective 6 - Change in NYHA Classification
Time Frame: 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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cardiac Dimensions, Inc.

Investigators

  • Principal Investigator: Randall Starling, MD, The Cleveland Clinic
  • Principal Investigator: Samir Kapadia, MD, The Cleveland Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2030

Study Registration Dates

First Submitted

May 2, 2017

First Submitted That Met QC Criteria

May 3, 2017

First Posted (Actual)

May 5, 2017

Study Record Updates

Last Update Posted (Actual)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 27, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CVP 1670-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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