Actively Recruiting
The EMPOWER Trial - The Carillon Mitral Contour System® in Treating Heart Failure With FMR
Led by Cardiac Dimensions, Inc. · Updated on 2026-04-13
300
Participants Needed
92
Research Sites
678 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
The EMPOWER Trial - The Carillon Mitral Contour System® in Treating Heart Failure With FMR
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Symptomatic heart failure with functional (secondary) mitral regurgitation of at least 1+ (mild) severity
- NYHA II, III, or IV
- Six Minute Walk distance 6 100 meters and 4 600 meters
- Left Ventricular Ejection Fraction 4 50%
- LVEDD 6 55 mm (women)
- LVEDD 6 57 mm (men)
- LVESD 4 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 6 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 will not qualify if you...
- Presence of a mechanical or bio-prosthetic mitral valve or mitral valve annuloplasty or leaflet repair device
- Significant organic mitral valve pathology such as 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 or valve disease within one year
- Chronic, severe medical conditions or pathology, other than heart failure, that will likely prevent survival beyond twelve months or any other medical condition judged to make the patient a poor candidate for this study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 92 locations
1
Dignity Health Research Institute at Mercy Gilbert and Chandler Regional Medical Centers
Gilbert, Arizona, United States, 85297
Actively Recruiting
2
Banner Health - Phoenix
Phoenix, Arizona, United States, 85006
Actively Recruiting
3
AZ Heart Rhythm
Phoenix, Arizona, United States, 85016
Withdrawn
4
Tucson Medical Center Health
Tucson, Arizona, United States, 85712
Actively Recruiting
5
Banner University Tuscon
Tucson, Arizona, United States, 85724
Actively Recruiting
6
Memorial Care Hospital
Long Beach, California, United States, 90806
Terminated
7
Keck School of Medicine of USC
Los Angeles, California, United States, 90033
Actively Recruiting
8
UCLA Medical Center
Los Angeles, California, United States, 90095
Actively Recruiting
9
Stanford University
Redwood City, California, United States, 94063
Actively Recruiting
10
Scripps Health
San Diego, California, United States, 92037
Actively Recruiting
11
University of California- San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
12
South Denver Cardiology
Littleton, Colorado, United States, 80210
Actively Recruiting
13
Medstar
Washington D.C., District of Columbia, United States, 20010
Terminated
14
Delray Medical Center
Delray Beach, Florida, United States, 33484
Terminated
15
University of Miami
Miami, Florida, United States, 33136
Terminated
16
Baptist Hospital of Miami
Miami, Florida, United States, 33176
Terminated
17
Advent Health Hospital
Orlando, Florida, United States, 32803
Actively Recruiting
18
Palm Beach Gardens Medical
Palm Beach, Florida, United States, 33410
Actively Recruiting
19
Tallahassee Research Institute
Tallahassee, Florida, United States, 32308
Active, Not Recruiting
20
Tampa General Hospital
Tampa, Florida, United States, 33606
Actively Recruiting
21
Augusta University Research Institute
Augusta, Georgia, United States, 30912
Terminated
22
Wellstar Health System,
Marietta, Georgia, United States, 30062
Terminated
23
Rush University Medical Center
Chicago, Illinois, United States, 60612
Terminated
24
Advocate Good Samaritan
Downers Grove, Illinois, United States, 60515
Actively Recruiting
25
Midwest Cardiovascular Institute (MCI)
Naperville, Illinois, United States, 60540
Actively Recruiting
26
Prairie Heart Institute
Springfield, Illinois, United States, 62701
Terminated
27
Carle Foundation Hospital
Urbana, Illinois, United States, 61801
Terminated
28
Community Health Network
Indianapolis, Indiana, United States, 46256
Actively Recruiting
29
Cardiovascular Institute South
Houma, Louisiana, United States, 70360
Actively Recruiting
30
Ochsner Health System
New Orleans, Louisiana, United States, 70121
Actively Recruiting
31
Johns Hopkins
Baltimore, Maryland, United States, 21287
Actively Recruiting
32
St Elizabeth's Medical Center
Boston, Massachusetts, United States, 02135
Actively Recruiting
33
Massachusetts General Hospital
Boston, Massachusetts, United States, 02145
Actively Recruiting
34
Beth Israel Deaconess
Boston, Massachusetts, United States, 02215
Actively Recruiting
35
University of Michigan
Ann Arbor, Michigan, United States, 48859
Terminated
36
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
Withdrawn
37
Ascension St. Marys Research Institute
Saginaw, Michigan, United States, 48601
Terminated
38
CentraCare Heart and Vascular
Saint Cloud, Minnesota, United States, 57584
Actively Recruiting
39
St. Louis Heart and Vascular
St Louis, Missouri, United States, 63044
Actively Recruiting
40
Deborah Heart & Lung
Browns Mills, New Jersey, United States, 08015
Actively Recruiting
41
Hackensack University Medical Center
Edison, New Jersey, United States, 07601
Actively Recruiting
42
St Michael/Prime Healthcare Services
Newark, New Jersey, United States, 07102
Actively Recruiting
43
Albany Medical College,
Albany, New York, United States, 12208
Terminated
44
University at Buffalo
Buffalo, New York, United States, 14203
Actively Recruiting
45
Northwell Staten Island
New York, New York, United States, 11030
Actively Recruiting
46
Vassar Brothers- Hudson Valley Cardiovascular Practice
Poughkeepsie, New York, United States, 12601
Actively Recruiting
47
Rochester Regional Hospital
Rochester, New York, United States, 14621
Actively Recruiting
48
Lindner Research Center at the Christ Hospital
Cincinnati, Ohio, United States, 45219
Actively Recruiting
49
Harrington Vascular
Cleveland, Ohio, United States, 44106
Terminated
50
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
51
The Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
52
Kettering Health Research Institute
Dayton, Ohio, United States, 45459
Actively Recruiting
53
Oklahoma Heart Institute Hospital
Tulsa, Oklahoma, United States, 74104
Actively Recruiting
54
Saint Francis Hospital,
Tulsa, Oklahoma, United States, 74136
Actively Recruiting
55
Oregon Health & Science University (OHSU)
Portland, Oregon, United States, 97225
Actively Recruiting
56
Providence Heart Institute
Portland, Oregon, United States, 97225
Actively Recruiting
57
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822
Active, Not Recruiting
58
Penn Medicine Lancaster General Health
Lancaster, Pennsylvania, United States, 17602
Actively Recruiting
59
UPMC Pinnacle Hospitals
Mechanicsburg, Pennsylvania, United States, 17050
Actively Recruiting
60
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19014
Actively Recruiting
61
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Withdrawn
62
Allegheny Health Network
Pittsburgh, Pennsylvania, United States, 15212
Actively Recruiting
63
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Withdrawn
64
Lankenau Institute of Medical Research
Wynnewood, Pennsylvania, United States, 19096
Actively Recruiting
65
North Central Heart-Avera
Sioux Falls, South Dakota, United States, 57108
Actively Recruiting
66
Methodist Le Bonheur Healthcare
Memphis, Tennessee, United States, 38104
Withdrawn
67
Centennial Medical Center
Nashville, Tennessee, United States, 37203
Actively Recruiting
68
Houston Healthcare Medical Center
Houston, Texas, United States, 77004
Actively Recruiting
69
Intermountain Medical Center
Salt Lake City, Utah, United States, 84111
Terminated
70
University of Virginia Health System
Charlottesville, Virginia, United States, 22903
Withdrawn
71
Henrico Doctors Hospital
Henrico, Virginia, United States, 23229
Actively Recruiting
72
Sentara Norfolk General Hospital
Norfolk, Virginia, United States, 23507
Withdrawn
73
HCA Chippenham Medical Center
Richmond, Virginia, United States, 23225
Actively Recruiting
74
Carilion Hospital
Roanoke, Virginia, United States, 24014
Actively Recruiting
75
Advocate Aurora Research Institute
Milwaukee, Wisconsin, United States, 53215
Actively Recruiting
76
University of Alberta
Edmonton, Alberta, Canada
Withdrawn
77
St Boniface Hospital - University of Manitoba
Winnipeg, Manitoba, Canada
Actively Recruiting
78
Toronto General Hospital
Toronto, Ontario, Canada
Actively Recruiting
79
Unity Health Toronto, St Michael's Hospital
Toronto, Ontario, Canada
Actively Recruiting
80
Pole Sante Republique
Clermont-Ferrand, France
Actively Recruiting
81
Centre Hospitalier Universitaire De Lille
Lille, France
Withdrawn
82
Hôpital Cardiologique Louis Pradel
Lyon, France
Actively Recruiting
83
Clinique du Millènaire Montpelier
Montpellier, France
Actively Recruiting
84
Hôpital Européen Georges-Pompidou
Paris, France
Withdrawn
85
European Interbalkan Medical Center
Thessaloniki, Greece
Actively Recruiting
86
Università Federico Naples
Naples, Italy
Actively Recruiting
87
Policinico Umbeto I
Roma, Italy
Not Yet Recruiting
88
Poznan University of Medical Sciences
Poznan, Poland, Poland, 61-485
Actively Recruiting
89
Hospital Clinic de Barcelona
Barcelona, Spain
Not Yet Recruiting
90
Hospital 12 de Octubre
Madrid, Spain
Not Yet Recruiting
91
University Clinical Hospital of Valladolid
Valladolid, Spain
Not Yet Recruiting
92
St James University Hospital
Leeds, United Kingdom
Actively Recruiting
Research Team
H
Hank Hauser
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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