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
1500 participants
INTERVENTIONAL
2022-02-03
2029-02-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
CCM in Heart Failure With Preserved Ejection Fraction
NCT03240237
Assessment of Combined CCM and ICD Device in HFrEF
NCT05855135
Propensity-Matched Study of Cardiac Contractility Modulation Therapy in Heart Failure
NCT07209098
Continued Access Protocol for the Evaluation of the OPTIMIZER Smart System
NCT03102437
Cardiac Contractility Modulation (CCM) Therapy in Subjects With Medically Refractory Heart Failure
NCT02857309
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
All subjects will undergo screening and baseline testing; all eligible subjects will be implanted with the Optimizer System. Subjects will be randomized in a 2:1 ratio to either CCM ON (CCM group) or to CCM OFF (Sham group). The trial will be blinded to the treatment assignment of the device for 18-months. Subjects in the Sham group will have CCM turned ON after completion of the 18-month study visit. Subjects enrolled during Part I (450 subjects) of the trial will continue follow-up through the end of Part II (up to an additional 1,050) and contribute data to both parts of the trial. Each part of the trial is distinguished by a separate scientific purpose. The specific purpose of each part is:
Part I - Establish safety and effectiveness based on functional capacity and health status.
Part II - Establish safety and effectiveness based on clinical outcome data.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
CCM Group (CCM ON)
CCM therapy will be turned on in 2/3 of the subjects for the entire duration of the study.
Cardiac Contractility Modulation Therapy via OPTIMIZER™ Smart Mini System
The OPTIMIZER™ Smart Mini System will be implanted and CCM will be programmed ON for the first 18 months (blinded phase). CCM therapy will be programmed to deliver 7 one-hour phases of CCM therapy that are distributed equally over every 24-hour period. CCM will remain on following completion of the 18-month visit.
Sham Group (CCM OFF)
CCM therapy will be turned off in 1/3 of the subjects for the first 18 months of the study. After 18 months, CCM therapy will be turned on for the rest of the study duration.
OPTIMIZER™ Smart Mini System
The OPTIMIZER™ Smart Mini System will be implanted and CCM will be programmed OFF for the first 18 months (blinded phase). CCM will be turned on following completion of the 18-month visit.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Cardiac Contractility Modulation Therapy via OPTIMIZER™ Smart Mini System
The OPTIMIZER™ Smart Mini System will be implanted and CCM will be programmed ON for the first 18 months (blinded phase). CCM therapy will be programmed to deliver 7 one-hour phases of CCM therapy that are distributed equally over every 24-hour period. CCM will remain on following completion of the 18-month visit.
OPTIMIZER™ Smart Mini System
The OPTIMIZER™ Smart Mini System will be implanted and CCM will be programmed OFF for the first 18 months (blinded phase). CCM will be turned on following completion of the 18-month visit.
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. Male or non-pregnant female, 18 years or older;
3. Diagnosed with symptomatic heart failure;
4. LVEF ≥40 and ≤70% (as assessed by site echo);
5. A. Heart failure hospitalization within 12 months prior to study consent OR an urgent heart failure visit requiring IV therapy within 6 months prior to study consent OR B. If there is no heart failure hospitalization within 12 months prior to study consent OR an urgent heart failure visit requiring IV therapy within 6 months prior to study consent, an elevated BMI-adjusted natriuretic peptide value must be achieved (Refer to Table 1 in Section 9.2.6)
6. Subjects must meet one of the following conditions:
* Have stable, scheduled oral loop diuretic treatment (not just PRN) for a minimum of 30 days before providing study consent unless there is a documented allergy or intolerance.
* Eligibility for enrollment is maintained for patients on an SGLT2 inhibitor without prescribed concurrent standing loop diuretic therapy if investigators provide instructions for a flexible PRN diuretic regimen (deemed appropriate by the clinician in response to symptoms or weight gain) Note: Stable is defined as no more than a 100% increase or 50% decrease in dose within the last 30 days. A one-time hold of diuretic dosing for 24 hours during the 30-day period is allowed and not an exclusionary event.
Exclusion Criteria
2. Resting systolic blood pressure \<100 or ≥160 mmHg;
3. BMI greater than 46
4. Any severe valvular stenotic disease or any severe valvular regurgitation;
5. Mechanical tricuspid valve;
6. Complex congenital heart disease;
7. Exercise tolerance limited by a condition other than heart failure that, in the opinion of the investigator, contributes significantly to the primary symptoms of shortness of breath and/or exercise intolerance;
8. Unable to walk at least 100 meters or walks more than 450 meters during a 6MWT;
9. A KCCQ CCS score higher than 85;
10. Hypertrophic, infiltrative/restrictive or inflammatory cardiomyopathy;
11. Unstable angina pectoris within 30 days prior to study consent;
12. Acute, decompensated heart failure requiring IV therapy or ultrafiltration within 30 days prior to consent, in the hospital or an outpatient setting;
13. Receiving cardiac resynchronization therapy (CRT); NOTE: Subjects with active/ongoing cardiac resynchronization therapy (CRT) implanted more than one year ago are eligible for inclusion if they are currently classified as NYHA class III or higher.
14. Scheduled for a cardiac surgery or a percutaneous cardiac intervention (PCI) or have undergone cardiac surgery within 90 days or a PCI procedure within 30 days prior to study consent;
15. Myocardial infarction within 90 days prior to study consent;
16. Prior heart transplant or ventricular assist device;
17. Planning to become pregnant during the study;
18. Dialysis (permanent) or GFR \<15 ml/min/1.73m2;
19. Participating in another investigational drug or device study that may interfere with the interpretation of study data;
20. Currently undergoing active chemotherapeutic and/or radiation treatment for cancer or has a history of chemotherapy during the 2-year period prior to study consent;
21. Expected lifespan of less than 18 months from time of study consent;
22. Unable to follow through study protocol for any reasons in the investigator's judgement.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Impulse Dynamics
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.
Javed Butler, MD, MPH, MBA
Role: PRINCIPAL_INVESTIGATOR
Baylor Scott and White Research Institute, Dallas, Texas
Oussama Wazni, MD, MBA
Role: PRINCIPAL_INVESTIGATOR
Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio, USA
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Grandview Medical Group Research, LLC
Birmingham, Alabama, United States
The University of Alabama at Birmingham
Birmingham, Alabama, United States
CardioVascular Associates of Mesa
Mesa, Arizona, United States
Chan Heart Rhythm Institute
Mesa, Arizona, United States
Southwest Cardiovascular Associates
Mesa, Arizona, United States
Banner Health- Phoenix
Phoenix, Arizona, United States
Arizona Heart Rhythm
Phoenix, Arizona, United States
Cardiovascular Consultants, Ltd
Phoenix, Arizona, United States
HonorHealth
Scottsdale, Arizona, United States
Pima Heart and Vascular
Tuscon, Arizona, United States
John Muir Health
Concord, California, United States
Northbay Heart and Vascular
Fairfield, California, United States
University of California San Diego
La Jolla, California, United States
USC Keck School of Medicine
Los Angeles, California, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
Valley Clinical Trials Pasadena
Northridge, California, United States
Valley Clinical Trials- Northridge
Northridge, California, United States
Sequoia Hospital
Redwood City, California, United States
University of California Davis Health
Sacramento, California, United States
University of California, San Francisco
San Francisco, California, United States
Nuvance Health - Danbury Hospital
Danbury, Connecticut, United States
Hartford Healthcare
Hartford, Connecticut, United States
HCA Florida JFK Hospital
Atlantis, Florida, United States
Nouvelle Clinical Research LLC
Cutler Bay, Florida, United States
Holy Cross Hospital
Fort Lauderdale, Florida, United States
Broward Health
Fort Lauderdale, Florida, United States
Memorial Healthcare System
Hollywood, Florida, United States
Baptist Health South Florida
Miami, Florida, United States
NCA Research Institute - Florida
Naples, Florida, United States
AdventHealth Orlando
Orlando, Florida, United States
Revival Clinical Research
Orlando, Florida, United States
Tallahassee Research Institute
Tallahassee, Florida, United States
Cleveland Clinic Foundation - Florida Weston Hospital
Weston, Florida, United States
Piedmont Healthcare
Atlanta, Georgia, United States
WellStar Health System, Inc
Marietta, Georgia, United States
Franciscan Health Indianapolis
Indianapolis, Indiana, United States
Ascension Medical Group St. Vincent
Indianapolis, Indiana, United States
University of Iowa
Iowa City, Iowa, United States
MercyOne Iowa Heart
West Des Moines, Iowa, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Kansas City Cardiac Arrhythmia Research LLC
Overland Park, Kansas, United States
Baptist Health Lexington
Lexington, Kentucky, United States
University of Kentucky Research Foundation
Lexington, Kentucky, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Henry Ford St. John Hospital
Detroit, Michigan, United States
Ascension Providence Hospital
Southfield, Michigan, United States
Trinity health- Michigan Heart
Ypsilanti, Michigan, United States
Minneapolis Heart Institute at Abbott Northwestern Hospital
Minneapolis, Minnesota, United States
North Mississippi Medical Center
Tupelo, Mississippi, United States
St. Louis Heart and Vascular
Bridgeton, Missouri, United States
St. Luke's Hospital
Chesterfield, Missouri, United States
St. Lukes Hospital Kansas City (Mid America Heart Institute)
Kansas City, Missouri, United States
Bryan Heart
Lincoln, Nebraska, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Catholic Medical Center
Manchester, New Hampshire, United States
Our Lady of Lourdes
Camden, New Jersey, United States
Hackensack University Medical Center
Edison, New Jersey, United States
Jersey Shore University Medical Center
Edison, New Jersey, United States
Cooper Hospital- Cardiovascular Associates of Delaware Valley
Haddon Heights, New Jersey, United States
Atlantic Health System- Morristown Medical Center
Morristown, New Jersey, United States
Rutgers New Jersey Medical School
Piscataway, New Jersey, United States
AtlantiCare Regional Medical Center
Pomona, New Jersey, United States
Buffalo General
Buffalo, New York, United States
Weill Cornell Medicine
New York, New York, United States
Nuvance Health - Heart & Vascular Institute/Hudson Valley Cardiovascular Practice, PC
Poughkeepsie, New York, United States
Nuvance Health - Vassar brothers Medical Center
Poughkeepsie, New York, United States
Sanger Heart and Vascular
Charlotte, North Carolina, United States
TriHealth Bethesda
Cincinnati, Ohio, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Ohio State University Wexner Medical Center
Columbus, Ohio, United States
OhioHealth Research Institute
Columbus, Ohio, United States
Mercy Health- St. Vincent Medical Center LLC
Toledo, Ohio, United States
Oklahoma Heart Institute
Tulsa, Oklahoma, United States
St. Francis Hospital - Tulsa
Tulsa, Oklahoma, United States
Providence Heart & Vascular
Portland, Oregon, United States
Bryn Mawr Medical Specialists Association
Bryn Mawr, Pennsylvania, United States
UPMC Pinnacle Harrisburg
Harrisburg, Pennsylvania, United States
Penn State Hershey Medical City
Hershey, Pennsylvania, United States
Lancaster General Hospital
Lancaster, Pennsylvania, United States
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Tower Health Reading Hospital
Reading, Pennsylvania, United States
WellSpan Health
York, Pennsylvania, United States
Prisma Health Upstate
Greenville, South Carolina, United States
Bon Secours Upstate Cardiology
Greenville, South Carolina, United States
North Central Heart
Sioux Falls, South Dakota, United States
The Stern Cardiovascular Foundation
Germantown, Tennessee, United States
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, United States
Ascension Seton
Austin, Texas, United States
Austin Heart
Austin, Texas, United States
Baylor Scott and White Research Institute
Dallas, Texas, United States
HCA Medical City Dallas
Dallas, Texas, United States
Baylor Scott White- All Saints- Fort Worth
Fort Worth, Texas, United States
Medical City Fort Worth Hospital
Fort Worth, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Houston Methodist
Houston, Texas, United States
Memorial Hermann Texas Medical Center
Houston, Texas, United States
Heart Rhythm Specialists
McKinney, Texas, United States
Baylor Scott and White- The Heart Hospital- Plano
Plano, Texas, United States
Baylor Scott and White Research Institute - Round Rock
Round Rock, Texas, United States
Methodist Hospital
San Antonio, Texas, United States
Bon Secours St. Mary's
Richmond, Virginia, United States
Bon Secours St. Mary's
Richmond, Virginia, United States
Swedish Medical Center
Seattle, Washington, United States
Peace Health
Vancouver, Washington, United States
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.
References
Explore related publications, articles, or registry entries linked to this study.
Abraham WT, Kuck KH, Goldsmith RL, Lindenfeld J, Reddy VY, Carson PE, Mann DL, Saville B, Parise H, Chan R, Wiegn P, Hastings JL, Kaplan AJ, Edelmann F, Luthje L, Kahwash R, Tomassoni GF, Gutterman DD, Stagg A, Burkhoff D, Hasenfuss G. A Randomized Controlled Trial to Evaluate the Safety and Efficacy of Cardiac Contractility Modulation. JACC Heart Fail. 2018 Oct;6(10):874-883. doi: 10.1016/j.jchf.2018.04.010. Epub 2018 May 10.
Wiegn P, Chan R, Jost C, Saville BR, Parise H, Prutchi D, Carson PE, Stagg A, Goldsmith RL, Burkhoff D. Safety, Performance, and Efficacy of Cardiac Contractility Modulation Delivered by the 2-Lead Optimizer Smart System: The FIX-HF-5C2 Study. Circ Heart Fail. 2020 Apr;13(4):e006512. doi: 10.1161/CIRCHEARTFAILURE.119.006512. Epub 2020 Apr 8.
Tschope C, Butler J, Farmakis D, Morley D, Rao I, Filippatos G. Clinical effects of cardiac contractility modulation in heart failure with mildly reduced systolic function. ESC Heart Fail. 2020 Dec;7(6):3531-3535. doi: 10.1002/ehf2.13126. Epub 2020 Dec 3.
Tschope C, Van Linthout S, Spillmann F, Klein O, Biewener S, Remppis A, Gutterman D, Linke WA, Pieske B, Hamdani N, Roser M. Cardiac contractility modulation signals improve exercise intolerance and maladaptive regulation of cardiac key proteins for systolic and diastolic function in HFpEF. Int J Cardiol. 2016 Jan 15;203:1061-6. doi: 10.1016/j.ijcard.2015.10.208. Epub 2015 Oct 27. No abstract available.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CA_CP_340
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.