Percutaneous mitral annuloplasty for functional mitral regurgitation: results of the CARILLON Mitral Annuloplasty Device European Union Study.
Joachim Schofer, Tomasz Siminiak, Michael Haude...
https://pubmed.ncbi.nlm.nih.gov/19597051Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID03142152
Assessment of the Carillon Mitral Contour System in Treating Heart Failure With Functional Mitral Regurgitation
Led by Cardiac Dimensions, Inc. · Updated on 2026-04-13
300
Participants Needed
92
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of the Carillon Mitral Contour System (CMCS) in treating patients with heart failure who also have functional mitral regurgitation (FMR). This prospective, randomized, double-blinded, sham-controlled trial aims to better understand how this device may impact heart function and symptoms in people with this condition. Participants will be randomly assigned to one of two groups: one group will receive the Carillon implant along with guideline-directed heart failure medications, while the other group will receive only the heart failure medications and a sham procedure to preserve blinding. Before randomization, patients will undergo specific heart imaging tests and evaluations to determine eligibility and suitability for the device placement. After the procedure, participants will have follow-up visits at 1, 6, 12, 18, and 24 months to monitor safety and heart function. After 24 months, all participants will be informed of their group assignment and followed annually for an additional three years. During the study, researchers will assess various health outcomes including freedom from major adverse events at 12 months and clinical improvement at 24 months. Additional measures will include changes in heart valve function, heart size, walking ability, heart failure symptoms, hospitalizations, and quality of life. Participants will have regular heart imaging, clinical evaluations, and questionnaires to track these outcomes. The total participation time may extend up to five years with long-term monitoring to better understand the device’s impact over time.
CONDITIONS
Brief Title
The EMPOWER Trial - The Carillon Mitral Contour System® in Treating Heart Failure With FMR
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Symptomatic heart failure with at least mild (1+) functional mitral regurgitation
- New York Heart Association (NYHA) class II, III, or IV
- Six Minute Walk distance between 100 and 600 meters
- Left Ventricular Ejection Fraction 50% or less
- Left Ventricular End-Diastolic Diameter (LVEDD) at least 55 mm (women) or 57 mm (men)
- Left Ventricular End-Systolic Diameter (LVESD) of 75 mm or less
- Corrected NT-proBNP over 1200 pg/ml within 60 days of randomization and/or recent heart failure hospitalizations or therapy intensifications
- Receiving optimal guideline-directed heart failure medical therapy
- Suitable anatomy for Carillon implant placement per instructions for use
- Willing and able to provide informed consent and complete all follow-up visits
You will not qualify if you...
- Presence of mechanical or bio-prosthetic mitral valve, mitral valve annuloplasty, or leaflet repair device
- Significant organic mitral valve disease such as moderate or severe myxomatous degeneration or rheumatic disease
- Severe tricuspid regurgitation with right ventricular dysfunction and enlargement
- Severe mitral annular calcification
- Severe aortic stenosis
- Expected cardiac surgery within one year including coronary artery disease or valve surgery
- Severe chronic medical conditions other than heart failure likely to limit survival beyond 12 months or making patient unsuitable for study participation
- Other clinical conditions judged by investigators to be poor candidates for the study
AI-Screening
AI-Powered Screening
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Implementation
Duration - Procedure day
Participants randomized to the Intervention group undergo the Carillon implant procedure. Participants in the Control group have a similar index procedure without implant placement to maintain blinding.
1 procedure visit (in-person)
Post-operative Follow-up
Duration - 24 months
After discharge, participants are followed up to assess long-term safety and clinical status.
5 visits at 1, 6, 12, 18, and 24 months post-randomization
Long-term Monitoring
Duration - 3 years
Participants are followed annually with contact and echocardiogram to monitor ongoing status.
Annual visits for 3 years after 24-month evaluation
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
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Research Team
H
Hank Hauser
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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Published Research Related To This Trial
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https://pubmed.ncbi.nlm.nih.gov/22613584Coronary sinus-based percutaneous annuloplasty as treatment for functional mitral regurgitation: the TITAN II trial.
Janusz Lipiecki, Tomasz Siminiak, Horst Sievert...
https://pubmed.ncbi.nlm.nih.gov/27493761