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

NCT03142152 | Recruiting DMC FDA Device

• 1 other identifier: CVP 1670-01
• Study Type: interventional
• Target: 300
• Locations: 8 countries
• Sites: 92

Brief Summary

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).

Conditions

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

Keywords

Functional Mitral Regurgitation; Percutaneous Mitral Valve Repair; Percutaneous Mitral Valve Annuloplasty; Coronary Sinus Annuloplasty; Secondary Mitral Regurgitation; Functional MR; FMR

Outcome Measures

Primary Outcomes (2)

• Primary Safety Objective - Freedom from Major Adverse Events

  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

  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 Outcomes (10)

• Secondary Efficacy Objective 1- Regurgitant Volume

  12 months

• Secondary Efficacy Objective 2 - Change in LV End-diastolic Volume

  12 months

• Secondary Efficacy Objective 3 - Change in NYHA

  12 months

• Secondary Efficacy Objective 4 - Hierarchical Clinical Composite

  12 months

• Secondary Efficacy Objective 5 - Heart Failure Hospitalizations

  12 months of follow-up, and any available data up to 24 months

Study Arms (2)

Intervention Group

EXPERIMENTAL

Carillon Mitral Contour System and Guideline Directed Heart Failure Medication

Device: Carillon Mitral Contour System; Other: Guideline Directed Heart Failure Medication

Control Group

ACTIVE COMPARATOR

Guideline Directed Heart Failure Medication

Other: Guideline Directed Heart Failure Medication

Interventions

Guideline Directed Heart Failure Medication OTHER

Heart failure medication per ACC/AHA guidelines

Control Group; Intervention Group

Carillon Mitral Contour System DEVICE

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.

Also known as: Carillon, Percutaneous mitral valve repair

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Cardiac Dimensions, Inc.: lead

Study Sites (92)

Dignity Health Research Institute at Mercy Gilbert and Chandler Regional Medical Centers

Gilbert, Arizona, 85297, United States

RECRUITING

Banner Health - Phoenix

Phoenix, Arizona, 85006, United States

RECRUITING

AZ Heart Rhythm

Phoenix, Arizona, 85016, United States

WITHDRAWN

Tucson Medical Center Health

Tucson, Arizona, 85712, United States

RECRUITING

Banner University Tuscon

Tucson, Arizona, 85724, United States

RECRUITING

Memorial Care Hospital

Long Beach, California, 90806, United States

TERMINATED

Keck School of Medicine of USC

Los Angeles, California, 90033, United States

RECRUITING

UCLA Medical Center

Los Angeles, California, 90095, United States

RECRUITING

Stanford University

Redwood City, California, 94063, United States

RECRUITING

Scripps Health

San Diego, California, 92037, United States

RECRUITING

University of California- San Francisco

San Francisco, California, 94143, United States

RECRUITING

South Denver Cardiology

Littleton, Colorado, 80210, United States

RECRUITING

Medstar

Washington D.C., District of Columbia, 20010, United States

TERMINATED

Delray Medical Center

Delray Beach, Florida, 33484, United States

TERMINATED

University of Miami

Miami, Florida, 33136, United States

TERMINATED

Baptist Hospital of Miami

Miami, Florida, 33176, United States

TERMINATED

Advent Health Hospital

Orlando, Florida, 32803, United States

RECRUITING

Palm Beach Gardens Medical

Palm Beach, Florida, 33410, United States

RECRUITING

Tallahassee Research Institute

Tallahassee, Florida, 32308, United States

ACTIVE NOT RECRUITING

Tampa General Hospital

Tampa, Florida, 33606, United States

RECRUITING

Augusta University Research Institute

Augusta, Georgia, 30912, United States

TERMINATED

Wellstar Health System,

Marietta, Georgia, 30062, United States

TERMINATED

Rush University Medical Center

Chicago, Illinois, 60612, United States

TERMINATED

Advocate Good Samaritan

Downers Grove, Illinois, 60515, United States

RECRUITING

Midwest Cardiovascular Institute (MCI)

Naperville, Illinois, 60540, United States

RECRUITING

Prairie Heart Institute

Springfield, Illinois, 62701, United States

TERMINATED

Carle Foundation Hospital

Urbana, Illinois, 61801, United States

TERMINATED

Community Health Network

Indianapolis, Indiana, 46256, United States

RECRUITING

Cardiovascular Institute South

Houma, Louisiana, 70360, United States

RECRUITING

Ochsner Health System

New Orleans, Louisiana, 70121, United States

RECRUITING

Johns Hopkins

Baltimore, Maryland, 21287, United States

RECRUITING

St Elizabeth's Medical Center

Boston, Massachusetts, 02135, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02145, United States

RECRUITING

Beth Israel Deaconess

Boston, Massachusetts, 02215, United States

RECRUITING

University of Michigan

Ann Arbor, Michigan, 48859, United States

TERMINATED

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

WITHDRAWN

Ascension St. Marys Research Institute

Saginaw, Michigan, 48601, United States

TERMINATED

CentraCare Heart and Vascular

Saint Cloud, Minnesota, 57584, United States

RECRUITING

St. Louis Heart and Vascular

St Louis, Missouri, 63044, United States

RECRUITING

Deborah Heart & Lung

Browns Mills, New Jersey, 08015, United States

RECRUITING

Hackensack University Medical Center

Edison, New Jersey, 07601, United States

RECRUITING

St Michael/Prime Healthcare Services

Newark, New Jersey, 07102, United States

RECRUITING

Albany Medical College,

Albany, New York, 12208, United States

TERMINATED

University at Buffalo

Buffalo, New York, 14203, United States

RECRUITING

Northwell Staten Island

New York, New York, 11030, United States

RECRUITING

Vassar Brothers- Hudson Valley Cardiovascular Practice

Poughkeepsie, New York, 12601, United States

RECRUITING

Rochester Regional Hospital

Rochester, New York, 14621, United States

RECRUITING

Lindner Research Center at the Christ Hospital

Cincinnati, Ohio, 45219, United States

RECRUITING

Harrington Vascular

Cleveland, Ohio, 44106, United States

TERMINATED

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

The Ohio State University

Columbus, Ohio, 43210, United States

RECRUITING

Kettering Health Research Institute

Dayton, Ohio, 45459, United States

RECRUITING

Oklahoma Heart Institute Hospital

Tulsa, Oklahoma, 74104, United States

RECRUITING

Saint Francis Hospital,

Tulsa, Oklahoma, 74136, United States

RECRUITING

Oregon Health & Science University (OHSU)

Portland, Oregon, 97225, United States

RECRUITING

Providence Heart Institute

Portland, Oregon, 97225, United States

RECRUITING

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

ACTIVE NOT RECRUITING

Penn Medicine Lancaster General Health

Lancaster, Pennsylvania, 17602, United States

RECRUITING

UPMC Pinnacle Hospitals

Mechanicsburg, Pennsylvania, 17050, United States

RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, 19014, United States

RECRUITING

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

WITHDRAWN

Allegheny Health Network

Pittsburgh, Pennsylvania, 15212, United States

RECRUITING

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

WITHDRAWN

Lankenau Institute of Medical Research

Wynnewood, Pennsylvania, 19096, United States

RECRUITING

North Central Heart-Avera

Sioux Falls, South Dakota, 57108, United States

RECRUITING

Methodist Le Bonheur Healthcare

Memphis, Tennessee, 38104, United States

WITHDRAWN

Centennial Medical Center

Nashville, Tennessee, 37203, United States

RECRUITING

Houston Healthcare Medical Center

Houston, Texas, 77004, United States

RECRUITING

Intermountain Medical Center

Salt Lake City, Utah, 84111, United States

TERMINATED

University of Virginia Health System

Charlottesville, Virginia, 22903, United States

WITHDRAWN

Henrico Doctors Hospital

Henrico, Virginia, 23229, United States

RECRUITING

Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States

WITHDRAWN

HCA Chippenham Medical Center

Richmond, Virginia, 23225, United States

RECRUITING

Carilion Hospital

Roanoke, Virginia, 24014, United States

RECRUITING

Advocate Aurora Research Institute

Milwaukee, Wisconsin, 53215, United States

RECRUITING

University of Alberta

Edmonton, Alberta, Canada

WITHDRAWN

St Boniface Hospital - University of Manitoba

Winnipeg, Manitoba, Canada

RECRUITING

Toronto General Hospital

Toronto, Ontario, Canada

RECRUITING

Unity Health Toronto, St Michael's Hospital

Toronto, Ontario, Canada

RECRUITING

Pole Sante Republique

Clermont-Ferrand, France

RECRUITING

Centre Hospitalier Universitaire De Lille

Lille, France

WITHDRAWN

Hôpital Cardiologique Louis Pradel

Lyon, France

RECRUITING

Clinique du Millènaire Montpelier

Montpellier, France

RECRUITING

Hôpital Européen Georges-Pompidou

Paris, France

WITHDRAWN

European Interbalkan Medical Center

Thessaloniki, Greece

RECRUITING

Università Federico Naples

Naples, Italy

RECRUITING

Policinico Umbeto I

Roma, Italy

NOT YET RECRUITING

Poznan University of Medical Sciences

Poznan, Poland, 61-485, Poland

RECRUITING

Hospital Clinic de Barcelona

Barcelona, Spain

NOT YET RECRUITING

Hospital 12 de Octubre

Madrid, Spain

NOT YET RECRUITING

University Clinical Hospital of Valladolid

Valladolid, Spain

NOT YET RECRUITING

St James University Hospital

Leeds, United Kingdom

RECRUITING

Related Publications (3)

• Schofer J, Siminiak T, Haude M, Herrman JP, Vainer J, Wu JC, Levy WC, Mauri L, Feldman T, Kwong RY, Kaye DM, Duffy SJ, Tubler T, Degen H, Brandt MC, Van Bibber R, Goldberg S, Reuter DG, Hoppe UC. Percutaneous mitral annuloplasty for functional mitral regurgitation: results of the CARILLON Mitral Annuloplasty Device European Union Study. Circulation. 2009 Jul 28;120(4):326-33. doi: 10.1161/CIRCULATIONAHA.109.849885. Epub 2009 Jul 13.

  PMID: 19597051 BACKGROUND

• Siminiak T, Wu JC, Haude M, Hoppe UC, Sadowski J, Lipiecki J, Fajadet J, Shah AM, Feldman T, Kaye DM, Goldberg SL, Levy WC, Solomon SD, Reuter DG. Treatment of functional mitral regurgitation by percutaneous annuloplasty: results of the TITAN Trial. Eur J Heart Fail. 2012 Aug;14(8):931-8. doi: 10.1093/eurjhf/hfs076. Epub 2012 May 21.

  PMID: 22613584 BACKGROUND

• Lipiecki J, Siminiak T, Sievert H, Muller-Ehmsen J, Degen H, Wu JC, Schandrin C, Kalmucki P, Hofmann I, Reuter D, Goldberg SL, Haude M. Coronary sinus-based percutaneous annuloplasty as treatment for functional mitral regurgitation: the TITAN II trial. Open Heart. 2016 Jul 8;3(2):e000411. doi: 10.1136/openhrt-2016-000411. eCollection 2016.

  PMID: 27493761 BACKGROUND

MeSH Terms

Conditions

Heart Failure; Mitral Valve Insufficiency; Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases

Study Officials

• Samir Kapadia, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

• Randall Starling, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hank Hauser

CONTACT

(310) 228-0016; hhauser@cardiacdimensions.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2017
• First Posted: May 5, 2017
• Study Start: January 1, 2018
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2030
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (4); PL (1); GR (1); FR (5); GB (1); US (75); ES (3); IT (2)