RecruitingNot ApplicableNCT03142152

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

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

Sponsor

Cardiac Dimensions, Inc.

Enrollment

300 participants

Start Date

Jan 1, 2018

Study Type

INTERVENTIONAL

Conditions

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

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).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a device called the Carillon Mitral Contour System, which is implanted near the heart to reduce a leaky heart valve (mitral regurgitation) and improve symptoms in people with heart failure. **You may be eligible if...** - You have heart failure with at least a mild leaky mitral valve (functional or secondary mitral regurgitation) - You have heart failure symptoms (any level — mild, moderate, or severe) - You can walk between 100 and 600 meters in 6 minutes - Your heart pumping ability (ejection fraction) is 50% or below - Your heart failure is being treated with the recommended medications **You may NOT be eligible if...** - Your mitral valve leakiness is caused by a structural defect in the valve itself (primary mitral regurgitation) - You have recently had a heart attack or heart procedure - Your kidney veins are blocked in a way that prevents device placement Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICECarillon 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.

OTHERGuideline Directed Heart Failure Medication

Heart failure medication per ACC/AHA guidelines

Locations(92)

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

Gilbert, Arizona, United States

Banner Health - Phoenix

Phoenix, Arizona, United States

AZ Heart Rhythm

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

South Denver Cardiology

Littleton, Colorado, United States

Medstar

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

Delray Medical Center

Delray Beach, Florida, United States

University of Miami

Miami, Florida, United States

Baptist Hospital of Miami

Miami, Florida, United States

Advent Health Hospital

Orlando, Florida, United States

Palm Beach Gardens Medical

Palm Beach, Florida, United States

Tallahassee Research Institute

Tallahassee, Florida, United States

Tampa General Hospital

Tampa, Florida, United States

Augusta University Research Institute

Augusta, Georgia, United States

Wellstar Health System,

Marietta, Georgia, United States

Rush University Medical Center

Chicago, Illinois, United States

Advocate Good Samaritan

Downers Grove, Illinois, United States

Midwest Cardiovascular Institute (MCI)

Naperville, Illinois, United States

Prairie Heart Institute

Springfield, Illinois, United States

Carle Foundation Hospital

Urbana, Illinois, United States

Community Health Network

Indianapolis, Indiana, United States

Cardiovascular Institute South

Houma, Louisiana, United States

Ochsner Health System

New Orleans, Louisiana, United States

Johns Hopkins

Baltimore, Maryland, United States

St Elizabeth's Medical Center

Boston, Massachusetts, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Beth Israel Deaconess

Boston, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

William Beaumont Hospital

Royal Oak, Michigan, United States

Ascension St. Marys Research Institute

Saginaw, Michigan, United States

CentraCare Heart and Vascular

Saint Cloud, Minnesota, United States

St. Louis Heart and Vascular

St Louis, Missouri, United States

Deborah Heart & Lung

Browns Mills, New Jersey, United States

Hackensack University Medical Center

Edison, New Jersey, United States

St Michael/Prime Healthcare Services

Newark, New Jersey, United States

Albany Medical College,

Albany, New York, United States

University at Buffalo

Buffalo, New York, United States

Northwell Staten Island

New York, New York, United States

Vassar Brothers- Hudson Valley Cardiovascular Practice

Poughkeepsie, New York, United States

Rochester Regional Hospital

Rochester, New York, United States

Lindner Research Center at the Christ Hospital

Cincinnati, Ohio, United States

Harrington Vascular

Cleveland, Ohio, United States

Cleveland Clinic

Cleveland, Ohio, United States

The Ohio State University

Columbus, Ohio, United States

Kettering Health Research Institute

Dayton, Ohio, United States

Oklahoma Heart Institute Hospital

Tulsa, Oklahoma, United States

Saint Francis Hospital,

Tulsa, Oklahoma, United States

Oregon Health & Science University (OHSU)

Portland, Oregon, United States

Providence Heart Institute

Portland, Oregon, United States

Geisinger Medical Center

Danville, Pennsylvania, United States

Penn Medicine Lancaster General Health

Lancaster, Pennsylvania, United States

UPMC Pinnacle Hospitals

Mechanicsburg, Pennsylvania, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Allegheny Health Network

Pittsburgh, Pennsylvania, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Lankenau Institute of Medical Research

Wynnewood, Pennsylvania, United States

North Central Heart-Avera

Sioux Falls, South Dakota, United States

Methodist Le Bonheur Healthcare

Memphis, Tennessee, United States

Centennial Medical Center

Nashville, Tennessee, United States

Houston Healthcare Medical Center

Houston, Texas, United States

Intermountain Medical Center

Salt Lake City, Utah, United States

University of Virginia Health System

Charlottesville, Virginia, United States

Henrico Doctors Hospital

Henrico, Virginia, United States

Sentara Norfolk General Hospital

Norfolk, Virginia, United States

HCA Chippenham Medical Center

Richmond, Virginia, United States

Carilion Hospital

Roanoke, Virginia, United States

Advocate Aurora Research Institute

Milwaukee, Wisconsin, United States

University of Alberta

Edmonton, Alberta, Canada

St Boniface Hospital - University of Manitoba

Winnipeg, Manitoba, Canada

Toronto General Hospital

Toronto, Ontario, Canada

Unity Health Toronto, St Michael's Hospital

Toronto, Ontario, Canada

Pole Sante Republique

Clermont-Ferrand, France

Centre Hospitalier Universitaire De Lille

Lille, France

Hôpital Cardiologique Louis Pradel

Lyon, France

Clinique du Millènaire Montpelier

Montpellier, France

Hôpital Européen Georges-Pompidou

Paris, France

European Interbalkan Medical Center

Thessaloniki, Greece

Università Federico Naples

Naples, Italy

Policinico Umbeto I

Roma, Italy

Poznan University of Medical Sciences

Poznan, Poland, Poland

Hospital Clinic de Barcelona

Barcelona, Spain

Hospital 12 de Octubre

Madrid, Spain

University Clinical Hospital of Valladolid

Valladolid, Spain

St James University Hospital

Leeds, United Kingdom

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NCT03142152

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