A Randomized Controlled Trial to Evaluate the Safety and Efficacy of Cardiac Contractility Modulation.
William T Abraham, Karl-Heinz Kuck, Rochelle L Goldsmith...
https://pubmed.ncbi.nlm.nih.gov/29754812Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID05064709
Assessment of Implantable Cardiac Contractility Modulation Therapy in Heart Failure Patients With Higher Ejection Fraction
Led by Impulse Dynamics · Updated on 2026-05-06
1500
Participants Needed
105
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the safety and effectiveness of Cardiac Contractility Modulation (CCM) therapy in people with heart failure who have a left ventricular ejection fraction (LVEF) between 40% and 70%. This clinical trial includes two parts with separate scientific goals: Part I focuses on functional capacity and health status, while Part II evaluates clinical outcomes. The study is randomized, quadruple-blind, and sham-controlled, involving subjects from about 225 sites worldwide. Participants will have an OPTIMIZER Smart Mini System implanted that delivers CCM therapy. They will be randomly assigned in a 2:1 ratio to either have CCM therapy turned ON continuously or to a sham group with CCM therapy turned OFF for the first 18 months. After 18 months, the sham group will also have CCM therapy turned ON. CCM therapy consists of seven one-hour sessions distributed evenly over each 24-hour period. The study includes follow-up through both parts, lasting up to several years. During the study, participants will undergo screening and baseline testing before implantation. Researchers will measure changes in walking distance over six minutes and health status by the Kansas City Cardiomyopathy Questionnaire after six months. Safety will be assessed by tracking device- or procedure-related complications for 12 months. Clinical outcomes including mortality, morbidity, and health status will be reviewed after 18 months. Participants will be monitored regularly for these outcomes throughout the study duration.
CONDITIONS
Brief Title
Assessment of CCM in HF With Higher Ejection Fraction
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form
- Male or non-pregnant female, 18 years or older
- Diagnosed with symptomatic heart failure
- Left ventricular ejection fraction between 40% and 70% as assessed by echocardiogram
- Heart failure hospitalization within 12 months prior to consent OR urgent heart failure visit requiring IV therapy within 6 months prior to consent OR elevated BMI-adjusted natriuretic peptide if no recent hospitalization or urgent visit
- Stable, scheduled oral loop diuretic treatment for at least 30 days before consent or eligibility maintained on SGLT2 inhibitor with flexible PRN diuretic regimen
You will not qualify if you...
- Resting ventricular rate less than 50 or greater than 110 beats per minute
- Resting systolic blood pressure less than 100 or equal to or greater than 160 mmHg
- Body mass index greater than 46
- Severe valvular stenotic disease or severe valvular regurgitation
- Mechanical tricuspid valve
- Complex congenital heart disease
- Exercise intolerance caused by conditions other than heart failure
- Unable to walk at least 100 meters or can walk more than 450 meters during a 6-minute walk test
- Kansas City Cardiomyopathy Questionnaire Clinical Summary Score higher than 85
- Hypertrophic, infiltrative/restrictive, or inflammatory cardiomyopathy
- Unstable angina within 30 days prior to consent
- Acute decompensated heart failure requiring IV therapy or ultrafiltration within 30 days prior to consent
- Receiving cardiac resynchronization therapy unless implanted more than one year ago and classified as NYHA class III or higher
- Scheduled or recent cardiac surgery or percutaneous cardiac intervention
- Myocardial infarction within 90 days prior to consent
- Prior heart transplant or ventricular assist device
- Planning pregnancy during the study
- Permanent dialysis or severe kidney dysfunction
- Participation in another investigational drug or device study that may interfere
- Active chemotherapy or radiation treatment for cancer or treatment within two years prior to consent
- Expected lifespan less than 18 months
- Unable to follow study protocol as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - 1 day
Participants will have the OPTIMIZER™ Smart Mini System implanted to deliver Cardiac Contractility Modulation (CCM) therapy or sham treatment.
1 visit (in-person)
Treatment
Duration - 18 months
Participants receive CCM therapy programmed ON or OFF for the first 18 months during the blinded phase of the trial.
Regular visits during the 18-month study period to monitor safety and effectiveness
Treatment
Duration - Up to an additional 18 months or until study completion
After the initial 18 months, participants who were in the sham group will have CCM therapy turned ON and continue treatment.
Visits continue as scheduled for ongoing treatment and assessments
Follow-up
Duration - Up to 36 months in total
Participants are monitored for safety and clinical outcomes through the end of the study.
Periodic visits to assess health status and clinical outcomes
Trial Site Locations
Total: 105 locations
1
Grandview Medical Group Research, LLC
Birmingham, Alabama, United States, 35243
Actively Recruiting
2
CardioVascular Associates of Mesa
Mesa, Arizona, United States, 85206
Actively Recruiting
3
Chan Heart Rhythm Institute
Mesa, Arizona, United States, 85206
Actively Recruiting
4
Southwest Cardiovascular Associates
Mesa, Arizona, United States, 85208
Actively Recruiting
5
Arizona Heart Rhythm
Phoenix, Arizona, United States, 85016
Actively Recruiting
6
Cardiovascular Consultants, Ltd
Phoenix, Arizona, United States, 85032
Actively Recruiting
7
HonorHealth
Scottsdale, Arizona, United States, 85258
Actively Recruiting
8
Pima Heart and Vascular
Tuscon, Arizona, United States, 85712
Actively Recruiting
9
John Muir Health
Concord, California, United States, 94520
Actively Recruiting
10
University of California San Diego
La Jolla, California, United States, 92093
Actively Recruiting
11
USC Keck School of Medicine
Los Angeles, California, United States, 90033
Actively Recruiting
12
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
13
Valley Clinical Trials- Northridge
Northridge, California, United States, 91325
Actively Recruiting
14
Sequoia Hospital
Redwood City, California, United States, 94062
Actively Recruiting
15
University of California Davis Health
Sacramento, California, United States, 95817
Withdrawn
16
University of California, San Francisco
San Francisco, California, United States, 94143
Withdrawn
17
Nuvance Health - Danbury Hospital
Danbury, Connecticut, United States, 06810
Actively Recruiting
18
Hartford Healthcare
Hartford, Connecticut, United States, 06103
Actively Recruiting
19
HCA Florida JFK Hospital
Atlantis, Florida, United States, 33462
Actively Recruiting
20
Nouvelle Clinical Research LLC
Cutler Bay, Florida, United States, 33189
Actively Recruiting
21
Broward Health
Fort Lauderdale, Florida, United States, 33316
Actively Recruiting
22
Memorial Healthcare System
Hollywood, Florida, United States, 33021
Withdrawn
23
Baptist Health South Florida
Miami, Florida, United States, 33176
Actively Recruiting
24
NCA Research Institute - Florida
Naples, Florida, United States, 34102
Withdrawn
25
AdventHealth Orlando
Orlando, Florida, United States, 32803
Actively Recruiting
26
Revival Clinical Research
Orlando, Florida, United States, 32807
Actively Recruiting
27
Tallahassee Research Institute
Tallahassee, Florida, United States, 32308
Withdrawn
28
Cleveland Clinic Foundation - Florida Weston Hospital
Weston, Florida, United States, 33326
Actively Recruiting
29
Piedmont Healthcare
Atlanta, Georgia, United States, 30309
Withdrawn
30
Franciscan Health Indianapolis
Indianapolis, Indiana, United States, 46237
Withdrawn
31
Ascension Medical Group St. Vincent
Indianapolis, Indiana, United States, 46260
Actively Recruiting
32
University of Iowa
Iowa City, Iowa, United States, 52242
Actively Recruiting
33
MercyOne Iowa Heart
West Des Moines, Iowa, United States, 50266
Actively Recruiting
34
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
35
Kansas City Cardiac Arrhythmia Research LLC
Overland Park, Kansas, United States, 66211
Actively Recruiting
36
Baptist Health Lexington
Lexington, Kentucky, United States, 40503
Actively Recruiting
37
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
Withdrawn
38
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
39
University of Michigan
Ann Arbor, Michigan, United States, 48113
Actively Recruiting
40
Henry Ford St. John Hospital
Detroit, Michigan, United States, 48236
Actively Recruiting
41
Ascension Providence Hospital
Southfield, Michigan, United States, 48075
Actively Recruiting
42
Trinity health- Michigan Heart
Ypsilanti, Michigan, United States, 48197
Actively Recruiting
43
Minneapolis Heart Institute at Abbott Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Actively Recruiting
44
North Mississippi Medical Center
Tupelo, Mississippi, United States, 38801
Withdrawn
45
St. Louis Heart and Vascular
Bridgeton, Missouri, United States, 63044
Actively Recruiting
46
St. Luke's Hospital
Chesterfield, Missouri, United States, 63017
Withdrawn
47
St. Lukes Hospital Kansas City (Mid America Heart Institute)
Kansas City, Missouri, United States, 64111
Actively Recruiting
48
Bryan Heart
Lincoln, Nebraska, United States, 68506
Actively Recruiting
49
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-5331
Withdrawn
50
Catholic Medical Center
Manchester, New Hampshire, United States, 03102
Withdrawn
51
Our Lady of Lourdes
Camden, New Jersey, United States, 08103
Actively Recruiting
52
Hackensack University Medical Center
Edison, New Jersey, United States, 08837
Withdrawn
53
Jersey Shore University Medical Center
Edison, New Jersey, United States, 08837
Withdrawn
54
Cooper Hospital- Cardiovascular Associates of Delaware Valley
Haddon Heights, New Jersey, United States, 08035
Actively Recruiting
55
Atlantic Health System- Morristown Medical Center
Morristown, New Jersey, United States, 07960
Actively Recruiting
56
Rutgers New Jersey Medical School
Piscataway, New Jersey, United States, 08854
Withdrawn
57
AtlantiCare Regional Medical Center
Pomona, New Jersey, United States, 08240
Actively Recruiting
58
Buffalo General
Buffalo, New York, United States, 14203
Actively Recruiting
59
Weill Cornell Medicine
New York, New York, United States, 10021
Withdrawn
60
Nuvance Health - Heart & Vascular Institute/Hudson Valley Cardiovascular Practice, PC
Poughkeepsie, New York, United States, 12601
Actively Recruiting
61
Nuvance Health - Vassar brothers Medical Center
Poughkeepsie, New York, United States, 12601
Actively Recruiting
62
Sanger Heart and Vascular
Charlotte, North Carolina, United States, 28203
Withdrawn
63
TriHealth Bethesda
Cincinnati, Ohio, United States, 45202
Withdrawn
64
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Withdrawn
65
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Actively Recruiting
66
Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210
Actively Recruiting
67
OhioHealth Research Institute
Columbus, Ohio, United States, 43214
Actively Recruiting
68
Mercy Health- St. Vincent Medical Center LLC
Toledo, Ohio, United States, 43608
Withdrawn
69
Oklahoma Heart Institute
Tulsa, Oklahoma, United States, 74104
Actively Recruiting
70
St. Francis Hospital - Tulsa
Tulsa, Oklahoma, United States, 74136
Actively Recruiting
71
Providence Heart & Vascular
Portland, Oregon, United States, 97225
Actively Recruiting
72
Bryn Mawr Medical Specialists Association
Bryn Mawr, Pennsylvania, United States, 19010
Actively Recruiting
73
UPMC Pinnacle Harrisburg
Harrisburg, Pennsylvania, United States, 17110
Withdrawn
74
Penn State Hershey Medical City
Hershey, Pennsylvania, United States, 17033
Actively Recruiting
75
Lancaster General Hospital
Lancaster, Pennsylvania, United States, 17602
Withdrawn
76
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, United States, 19104-6061
Actively Recruiting
77
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
78
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
79
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140
Actively Recruiting
80
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
Actively Recruiting
81
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
82
Tower Health Reading Hospital
Reading, Pennsylvania, United States, 19611
Withdrawn
83
WellSpan Health
York, Pennsylvania, United States, 17403
Withdrawn
84
Prisma Health Upstate
Greenville, South Carolina, United States, 29601
Actively Recruiting
85
Bon Secours Upstate Cardiology
Greenville, South Carolina, United States, 29607
Withdrawn
86
North Central Heart
Sioux Falls, South Dakota, United States, 57108
Actively Recruiting
87
The Stern Cardiovascular Foundation
Germantown, Tennessee, United States, 38138
Actively Recruiting
88
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, United States, 78705
Withdrawn
89
Ascension Seton
Austin, Texas, United States, 78723
Actively Recruiting
90
Austin Heart
Austin, Texas, United States, 78756
Actively Recruiting
91
Baylor Scott and White Research Institute
Dallas, Texas, United States, 75204
Actively Recruiting
92
HCA Medical City Dallas
Dallas, Texas, United States, 75230
Withdrawn
93
Baylor Scott White- All Saints- Fort Worth
Fort Worth, Texas, United States, 76104
Actively Recruiting
94
Medical City Fort Worth Hospital
Fort Worth, Texas, United States, 76104
Actively Recruiting
95
Baylor College of Medicine
Houston, Texas, United States, 77030
Actively Recruiting
96
Houston Methodist
Houston, Texas, United States, 77030
Actively Recruiting
97
Memorial Hermann Texas Medical Center
Houston, Texas, United States, 77030
Actively Recruiting
98
Heart Rhythm Specialists
McKinney, Texas, United States, 75070
Actively Recruiting
99
Baylor Scott and White- The Heart Hospital- Plano
Plano, Texas, United States, 75093
Withdrawn
100
Baylor Scott and White Research Institute - Round Rock
Round Rock, Texas, United States, 78665
Actively Recruiting
101
Methodist Hospital
San Antonio, Texas, United States, 78229
Withdrawn
102
Bon Secours St. Mary's
Richmond, Virginia, United States, 23114
Actively Recruiting
103
Bon Secours St. Mary's
Richmond, Virginia, United States, 23226
Actively Recruiting
104
Swedish Medical Center
Seattle, Washington, United States, 98122
Actively Recruiting
105
Peace Health
Vancouver, Washington, United States, 98664
Actively Recruiting
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Research Team
R
Rachael Riccitello
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Safety, Performance, and Efficacy of Cardiac Contractility Modulation Delivered by the 2-Lead Optimizer Smart System: The FIX-HF-5C2 Study.
Phi Wiegn, Rodrigo Chan, Charles Jost...
https://pubmed.ncbi.nlm.nih.gov/32264716Clinical effects of cardiac contractility modulation in heart failure with mildly reduced systolic function.
Carsten Tschöpe, Javed Butler, Dimitrios Farmakis...
https://pubmed.ncbi.nlm.nih.gov/33274601Cardiac contractility modulation signals improve exercise intolerance and maladaptive regulation of cardiac key proteins for systolic and diastolic function in HFpEF.
Carsten Tschöpe, Sophie Van Linthout, Frank Spillmann...
https://pubmed.ncbi.nlm.nih.gov/26638055Cardiac contractility modulation: A new horizon in the management of heart failure with preserved ejection fraction (HFpEF).
Adnan Aneeq, Muneeb Jan, Sibtain Nisar...
https://pubmed.ncbi.nlm.nih.gov/37980262