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

April 8, 2026 updated by: Cardiac Dimensions, Inc.

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

A total of 300 subjects will be randomized at up to 100 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 the Carillon implant 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 implant 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

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada
        • Withdrawn
        • University of Alberta
    • Manitoba
      • Winnipeg, Manitoba, Canada
        • Recruiting
        • St Boniface Hospital - University of Manitoba
        • Principal Investigator:
          • Shelley Zieroth, MD
        • Contact:
    • Ontario
      • Toronto, Ontario, Canada
        • Recruiting
        • Toronto General Hospital
        • Principal Investigator:
          • Eric Horlick, MD
        • Contact:
      • Toronto, Ontario, Canada
        • Recruiting
        • Unity Health Toronto, St Michael's Hospital
        • Principal Investigator:
          • Neil Fam, MD
        • Contact:
  • France
      • Clermont-Ferrand, France
        • Recruiting
        • Pôle Santé République
        • Principal Investigator:
          • Janusz Lipiecki, MD
        • Contact:
      • Lille, France
        • Withdrawn
        • Centre Hospitalier Universitaire De Lille
      • Lyon, France
        • Recruiting
        • Hôpital cardiologique Louis Pradel
        • Contact:
        • Principal Investigator:
          • Nathan Mewton, Prof
      • Montpellier, France
        • Recruiting
        • Clinique du Millènaire Montpelier
        • Contact:
        • Principal Investigator:
          • Christopher Piot, Prof
      • Paris, France
        • Withdrawn
        • Hôpital Européen Georges-Pompidou
  • Greece
      • Thessaloniki, Greece
        • Recruiting
        • European Interbalkan Medical Center
        • Principal Investigator:
          • Vlasios Ninios, MD
        • Contact:
  • Italy
      • Naples, Italy
        • Recruiting
        • Università Federico Naples
        • Contact:
        • Principal Investigator:
          • Giovanni Esposito
      • Roma, Italy
        • Not yet recruiting
        • Policinico Umbeto I
        • Principal Investigator:
          • Massimo Mancone
        • Contact:
  • Poland
    • Poland
      • Poznan, Poland, Poland, 61-485
        • Recruiting
        • Poznan University of Medical Sciences
        • Contact:
  • Spain
      • Barcelona, Spain
        • Not yet recruiting
        • Hospital Clinic De Barcelona
        • Contact:
        • Principal Investigator:
          • Omar Abdul-Jawad
      • Madrid, Spain
        • Not yet recruiting
        • Hospital 12 de Octubre
        • Principal Investigator:
          • Jorge Nuche
        • Contact:
      • Valladolid, Spain
        • Not yet recruiting
        • University Clinical Hospital of Valladolid
        • Contact:
        • Principal Investigator:
          • Ignacio Amat-Santos
  • United Kingdom
      • Leeds, United Kingdom
        • Recruiting
        • St James University Hospital
        • Principal Investigator:
          • Klaus Witte, Prof
        • Sub-Investigator:
          • Christopher Malkin, MD
        • 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
        • Recruiting
        • Banner Health - Phoenix
        • Contact:
        • Principal Investigator:
          • Siddarth Singh, MD
      • Phoenix, Arizona, United States, 85016
        • Withdrawn
        • AZ Heart Rhythm
      • Tucson, Arizona, United States, 85724
        • Recruiting
        • Banner University Tuscon
        • Principal Investigator:
          • Arka Chatterjee, MD
        • Contact:
      • Tucson, Arizona, United States, 85712
        • Recruiting
        • Tucson Medical Center Health
        • Principal Investigator:
          • Tom Waggoner, MD
        • Contact:
    • California
      • Long Beach, California, United States, 90806
        • Terminated
        • Memorial Care Hospital
      • Los Angeles, California, United States, 90095
      • Los Angeles, California, United States, 90033
        • Recruiting
        • Keck School of Medicine of USC
        • Principal Investigator:
          • Ray Matthews, MD
        • Contact:
      • Redwood City, California, United States, 94063
        • Recruiting
        • Stanford University
        • Principal Investigator:
          • Rahul Sharma, MD
        • Contact:
      • San Diego, California, United States, 92037
      • San Francisco, California, United States, 94143
        • Recruiting
        • University of California- San Francisco
        • Contact:
        • Principal Investigator:
          • Pooja Prasad, MD
    • Colorado
      • Littleton, Colorado, United States, 80210
        • Recruiting
        • South Denver Cardiology
        • Principal Investigator:
          • Ira Dauber, MD
        • Contact:
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010
        • Terminated
        • MedStar
    • Florida
      • Delray Beach, Florida, United States, 33484
        • Terminated
        • Delray Medical Center
      • Miami, Florida, United States, 33136
        • Terminated
        • University of Miami
      • Miami, Florida, United States, 33176
        • Terminated
        • Baptist Hospital of Miami
      • Orlando, Florida, United States, 32803
      • Palm Beach, Florida, United States, 33410
        • Recruiting
        • Palm Beach Gardens Medical
        • Contact:
        • Principal Investigator:
          • Augusto Villa, MD
      • Tallahassee, Florida, United States, 32308
        • Active, not recruiting
        • Tallahassee Research Institute
      • Tampa, Florida, United States, 33606
        • Recruiting
        • Tampa General Hospital
        • Principal Investigator:
          • Jason Feliberti, MD
        • Contact:
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Terminated
        • Augusta University Research Institute
      • Marietta, Georgia, United States, 30062
        • Terminated
        • Wellstar Health System,
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Terminated
        • Rush University Medical Center
      • Downers Grove, Illinois, United States, 60515
        • Recruiting
        • Advocate Good Samaritan
        • Contact:
        • Principal Investigator:
          • Mahesh Raju, MD
      • Naperville, Illinois, United States, 60540
        • Recruiting
        • Midwest Cardiovascular Institute (MCI)
        • Principal Investigator:
          • Mark Goodwin, MD
        • Contact:
      • Springfield, Illinois, United States, 62701
        • Terminated
        • Prairie Heart Institute
      • Urbana, Illinois, United States, 61801
        • Terminated
        • Carle Foundation Hospital
    • Indiana
      • Indianapolis, Indiana, United States, 46256
        • Recruiting
        • Community Health Network
        • Contact:
        • Principal Investigator:
          • Sandeep Dube, MD
    • 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
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Johns Hopkins
        • Principal Investigator:
          • Rani Hasan, MD
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02135
        • Recruiting
        • St Elizabeth's Medical Center
        • Contact:
        • Principal Investigator:
          • Richard Patten, MD
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Beth Israel Deaconess
        • Contact:
        • Principal Investigator:
          • Arthur Garan, MD
      • Boston, Massachusetts, United States, 02145
        • Recruiting
        • Massachusetts General Hospital
        • Principal Investigator:
          • Rahul Sakhuja, MD
        • Contact:
    • Michigan
      • Ann Arbor, Michigan, United States, 48859
        • Terminated
        • University of Michigan
      • Royal Oak, Michigan, United States, 48073
        • Withdrawn
        • William Beaumont Hospital
      • Saginaw, Michigan, United States, 48601
        • Terminated
        • Ascension St. Marys Research Institute
    • Minnesota
      • Saint Cloud, Minnesota, United States, 57584
        • Recruiting
        • Centracare Heart and Vascular
        • Contact:
        • Principal Investigator:
          • Thom Dhale, MD
    • Missouri
      • St Louis, Missouri, United States, 63044
        • Recruiting
        • St. Louis Heart and Vascular
        • Contact:
        • Principal Investigator:
          • Gil Vardi, MD
    • New Jersey
      • Browns Mills, New Jersey, United States, 08015
        • Recruiting
        • Deborah Heart & Lung
        • Principal Investigator:
          • Richard Kovach, MD
        • Contact:
      • Edison, New Jersey, United States, 07601
        • Recruiting
        • Hackensack University Medical Center
        • Principal Investigator:
          • Ryan Kaple, MD
        • Contact:
      • Newark, New Jersey, United States, 07102
        • Recruiting
        • St Michael/Prime Healthcare Services
        • Contact:
        • Principal Investigator:
          • Addi Suleiman, MD
    • New York
      • Albany, New York, United States, 12208
        • Terminated
        • Albany Medical College,
      • Buffalo, New York, United States, 14203
        • Recruiting
        • University at Buffalo
        • Principal Investigator:
          • Vijay Iyer, MD
        • Contact:
      • New York, New York, United States, 11030
        • Recruiting
        • Northwell Staten Island
        • Principal Investigator:
          • Marcin Kowalski, MD
        • Contact:
      • Poughkeepsie, New York, United States, 12601
        • Recruiting
        • Vassar Brothers- Hudson Valley Cardiovascular Practice
        • Principal Investigator:
          • Rajeev Narayan, MD
        • Contact:
      • Rochester, New York, United States, 14621
        • Recruiting
        • Rochester Regional Hospital
        • Contact:
        • Principal Investigator:
          • Scott Feitell, MD
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Recruiting
        • Lindner Research Center at The Christ Hospital
        • Principal Investigator:
          • Sitaramesh Emani, MD
        • Contact:
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic
        • Principal Investigator:
          • Amar Krishnaswamy, MD
        • Contact:
      • Cleveland, Ohio, United States, 44106
        • Terminated
        • Harrington Vascular
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • The Ohio State University
        • Contact:
        • Principal Investigator:
          • Vaiibhav Patel, MD
      • Dayton, Ohio, United States, 45459
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74136
        • Recruiting
        • Saint Francis Hospital,
        • Principal Investigator:
          • Douglas Ensley, MD
        • Contact:
      • Tulsa, Oklahoma, United States, 74104
        • Recruiting
        • Oklahoma Heart Institute Hospital
        • Principal Investigator:
          • Kamran Muhammad, MD
        • Contact:
    • Oregon
      • Portland, Oregon, United States, 97225
        • Recruiting
        • Providence Heart Institute
        • Principal Investigator:
          • Brandon Jones, MD
        • Contact:
      • Portland, Oregon, United States, 97225
        • Recruiting
        • Oregon Health & Science University (OHSU)
        • Principal Investigator:
          • Johannes Steiner, MD
        • Contact:
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822
        • Active, not recruiting
        • Geisinger Medical Center
      • Lancaster, Pennsylvania, United States, 17602
      • Mechanicsburg, Pennsylvania, United States, 17050
        • Recruiting
        • UPMC Pinnacle Hospitals
        • Contact:
        • Principal Investigator:
          • Aashay Patel, MD
      • Philadelphia, Pennsylvania, United States, 19107
        • Withdrawn
        • Thomas Jefferson University
      • Philadelphia, Pennsylvania, United States, 19014
      • Pittsburgh, Pennsylvania, United States, 15212
        • Recruiting
        • Allegheny Health Network
        • Principal Investigator:
          • Mithun Chakravarthy, MD
        • Contact:
      • Pittsburgh, Pennsylvania, United States, 15213
        • Withdrawn
        • University of Pittsburgh Medical Center
      • Wynnewood, Pennsylvania, United States, 19096
        • Recruiting
        • Lankenau Institute of Medical Research
        • Contact:
        • Principal Investigator:
          • Christopher Droogan, MD
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57108
        • Recruiting
        • North Central Heart-Avera
        • Contact:
        • Principal Investigator:
          • John Wagener, MD
    • Tennessee
      • Memphis, Tennessee, United States, 38104
        • Withdrawn
        • Methodist Le Bonheur Healthcare
      • Nashville, Tennessee, United States, 37203
    • Texas
      • Houston, Texas, United States, 77004
        • Recruiting
        • Houston Healthcare Medical Center
        • Principal Investigator:
          • Pranav Loyalka, MD
        • Contact:
    • Utah
      • Salt Lake City, Utah, United States, 84111
        • Terminated
        • Intermountain Medical Center
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • Withdrawn
        • University of Virginia Health System
      • Henrico, Virginia, United States, 23229
      • Norfolk, Virginia, United States, 23507
        • Withdrawn
        • Sentara Norfolk General Hospital
      • Richmond, Virginia, United States, 23225
        • Recruiting
        • HCA Chippenham Medical Center
        • Contact:
        • Principal Investigator:
          • Hamza Lodhi, MD
      • Roanoke, Virginia, United States, 24014
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Recruiting
        • Advocate Aurora Research Institute
        • Principal Investigator:
          • Tanvir Bajwa, MD
        • 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. 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:

    • ≥ 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 Criteria:

  1. Presence of a mechanical or bio-prosthetic mitral valve or, mitral valve annuloplasty, or leaflet repair device
  2. 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)
  3. Severe tricuspid regurgitation associated with right ventricular dysfunction and enlargement
  4. Severe mitral annular calcification
  5. Severe aortic stenosis
  6. Expected to require any cardiac surgery, including surgery for coronary artery disease (CAD) or valve disease within one (1) year

  7. 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

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 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.)
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 in patients with at least MR grade 2+ at baseline
12 months
Secondary Efficacy Objective 2 - Change in LV End-diastolic Volume
Time Frame: 12 months
To compare the change from baseline left ventricular end-diastolic volume (LVEDV) relative to the Control group.
12 months
Secondary Efficacy Objective 3 - Change in NYHA
Time Frame: 12 months
To compare the change from baseline in New York Heart Association (NYHA) Classification, relative to Control, at twelve (12) months
12 months
Secondary Efficacy Objective 4 - Hierarchical Clinical Composite
Time Frame: 12 months
To compare the first four components of the hierarchical primary efficacy endpoint, relative to Control, analyzed when the last subject completes 12 months of follow up and use all available data up to twenty-four (24) months
12 months
Secondary Efficacy Objective 5 - Heart Failure Hospitalizations
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
Exploratory Secondary Endpoint 1 - Change in Six-Minute Walk Distance
Time Frame: 12 months
To compare the change improvement from baseline in six-minute walk distance (6MWD), relative to Control, at twelve (12) months
12 months
Exploratory Secondary Endpoint 2 - Change in KCCQ
Time Frame: 12 months
To compare the change from baseline, relative to the Control group, in the Overall Summary Score (OSS) of the Kansas City Cardiomyopathy Questionnaire (KCCQ), at twelve (12) months
12 months
Exploratory Secondary Endpoint 3 - Change in LV End-systolic Volume
Time Frame: 12 months
To compare the change from baseline in left ventricular end-systolic volume (LVESV), relative to Control, at twelve (12) months
12 months
Exploratory Secondary Endpoint 4 - days lost due to HFH and 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
Exploratory Secondary Endpoint 5 - Alternative Therapies
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

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)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 8, 2026

Last Verified

April 1, 2026

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

product manufactured in and exported from the U.S.

No

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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