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The EMPOWER Trial - The Carillon Mitral Contour System® in Treating Heart Failure With at Least Mild FMR
Sponsor: Cardiac Dimensions, Inc.
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).
Official title: Assessment of the Carillon Mitral Contour System® in Treating Heart Failure With at Least Mild Functional Mitral Regurgitation
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
300
Start Date
2018-01-01
Completion Date
2030-12-31
Last Updated
2026-03-30
Healthy Volunteers
No
Conditions
Interventions
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.
Guideline 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
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