The EMPOWER Trial - The Carillon Mitral Contour System® in Treating Heart Failure With at Least Mild FMR
NCT ID: NCT03142152
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
300 participants
INTERVENTIONAL
2018-01-01
2030-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Intervention Group
Carillon Mitral Contour System and Guideline Directed Heart Failure Medication
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
Control Group
Guideline Directed Heart Failure Medication
Guideline Directed Heart Failure Medication
Heart failure medication per ACC/AHA guidelines
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. NYHA II, III, or IV
3. Six Minute Walk distance ≥ 100 meters and ≤ 600 meters
4. Left Ventricular Ejection Fraction ≤ 50%
5. LVEDD ≥ 57 mm and LVESD ≤ 75 mm
6. Corrected BNP of \> 300 pg/ml, or corrected NT-proBNP \> 1200 pg/ml, or one or more heart failure hospitalizations within one year prior to consent
7. Guideline directed heart failure medication regimen
8. Age 18 years old
9. Carillon implant can be sized and placed in accordance with the IFU
10. 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
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)
4. Severe tricuspid regurgitation associated with right ventricular dysfunction and enlargement
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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Cardiac Dimensions, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Samir Kapadia, MD
Role: PRINCIPAL_INVESTIGATOR
The Cleveland Clinic
Randall Starling, MD
Role: PRINCIPAL_INVESTIGATOR
The Cleveland Clinic
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Dignity Health Research Institute at Mercy Gilbert and Chandler Regional Medical Centers
Gilbert, Arizona, United States
Banner Health - Phoenix
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
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
Advocate Good Samaritan
Downers Grove, Illinois, United States
Midwest Cardiovascular Institute (MCI)
Naperville, Illinois, United States
Prairie Heart Institute
Springfield, 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
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
Albany Medical College,
Albany, New York, United States
University at Buffalo
Buffalo, New York, United States
Vassar Brothers- Hudson Valley Cardiovascular Practice
Poughkeepsie, 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
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Allegheny Health Network
Pittsburgh, Pennsylvania, United States
Lankenau Institute of Medical Research
Wynnewood, Pennsylvania, United States
North Central Heart-Avera
Sioux Falls, South Dakota, United States
Centennial Medical Center
Nashville, Tennessee, United States
Houston Healthcare Medical Center
Houston, Texas, United States
University of Virginia Health System
Charlottesville, Virginia, United States
Henrico Doctors Hospital
Henrico, 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
Poznan University of Medical Sciences
Poznan, , Poland
St James University Hospital
Leeds, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Natalie Leon
Role: primary
Theresa Jorgensen
Role: primary
Adriana Olivares
Role: primary
Karina Carrillo
Role: primary
Karina Vargas Gonzalez
Role: primary
Silvia Perez
Role: primary
Ladda Douangvila
Role: primary
Josephine Widjaja
Role: primary
Alison Walton
Role: primary
Kaye Reambonanza
Role: primary
Andrea Kupser
Role: primary
Megan Fuller
Role: primary
Jordan Sprechman
Role: primary
Zoe Banchilhon
Role: primary
Ana Nelson
Role: primary
Andrea Tunnicliff
Role: primary
Alecia Sorrells
Role: primary
Jennifer Cuvo
Role: primary
Lynn McLennan
Role: primary
Josilyn Klimek
Role: primary
Brenda Newman
Role: primary
Vaidehi Patel
Role: primary
Angel Penning
Role: primary
Zyriah Robinson
Role: primary
Rina Vaquerano
Role: primary
Ella Claire Cook
Role: primary
Jacob Luetje
Role: primary
Kristin Levasseur
Role: primary
Nathan Warnert
Role: primary
Paige Brown
Role: primary
Andrew McElvarr, BS
Role: primary
Maria Manzo
Role: primary
Cassandra Davern
Role: primary
Tricia Landi
Role: primary
Wendy Parker
Role: primary
Emily Tylicki
Role: primary
Annie Kellum
Role: primary
Chris Seger
Role: primary
Tamara Morton
Role: primary
Jeremy Earnest
Role: primary
John Halvorson
Role: primary
Marcia Macsisak
Role: primary
Susan Kilbride
Role: primary
Andy Hershey
Role: primary
Elizabeth Madenilla
Role: primary
Miranda Nadeo
Role: primary
Hannah Epps
Role: primary
Patty Eisenbraun
Role: primary
Abigail Bentley
Role: primary
Swathi Potla
Role: primary
Melanie Dean
Role: primary
Michelle Egbujor
Role: primary
Michelle Egbujor
Role: primary
Brittny O'Toole
Role: primary
Dena Burke
Role: primary
Suzanne Welsch
Role: primary
Wendy Janz
Role: primary
Tania Jain
Role: primary
Ivana Kandic
Role: primary
Sandrine Duband
Role: primary
Marie Ghesquiere
Role: primary
Dominique Brun
Role: primary
Lisa Crespy
Role: primary
Sosanna Konstantinidou
Role: primary
Oi YI Lam
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CVP 1670-01
Identifier Type: -
Identifier Source: org_study_id