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
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ACTIVE_NOT_RECRUITING
NA
300 participants
INTERVENTIONAL
2023-05-17
2027-07-31
Brief Summary
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Eligible subjects will be implanted with the CCM-D System. A subset of subjects will be induced into ventricular fibrillation "on the table" in the implant procedure room. During the follow-up period, inappropriate shock rate and device-related complications will be evaluated. The follow-up period is expected to last at least two years.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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CCM-D Implant
The subject is implanted with the CCM-D device.
OPTIMIZER® Integra CCM-D System (Treatment Arm)
The CCM-D System is an implantable cardiac device system that combines cardiac contractility modulation and implantable cardioverter defibrillator (ICD) modules into one device. CCM-D is also known as a "Cardiac Contractility Modulation - Defibrillator". All 300 subjects will be implanted with the CCM-D System and followed for a period of at least two years.
Interventions
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OPTIMIZER® Integra CCM-D System (Treatment Arm)
The CCM-D System is an implantable cardiac device system that combines cardiac contractility modulation and implantable cardioverter defibrillator (ICD) modules into one device. CCM-D is also known as a "Cardiac Contractility Modulation - Defibrillator". All 300 subjects will be implanted with the CCM-D System and followed for a period of at least two years.
Eligibility Criteria
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Inclusion Criteria
1. Patient is aged 18 years or older;
2. Patient meets the Stage C or D criteria of the Universal Definition of Heart Failure ;
3. Patient has HFrEF (LVEF ≤40%);
4. Patient is on GDMT for heart failure;
5. Patient has a Class I or Class II indication for an ICD
6. Patient has a reasonable expectation of meaningful survival of \> 1 year;
7. Patient has either non-ischemic cardiomyopathy or ischemic cardiomyopathy and is at least 40 days post-MI, if an MI occurred;
8. Patient is willing to give informed consent, available for scheduled study follow-up visits, and able to complete all testing described in the study protocol at the investigational site location.
Exclusion Criteria
1. Patients should not have severe AI or AS, and should not have MS; additionally, patients undergoing DE testing should not have severe MR;
2. Patients who have undergone mitral valve repair or clip within 90 days prior to study consent;
3. Cardiac surgery within 90 days or a PCI procedure within 30 days prior to study consent;
4. Prior heart transplant or ventricular assist device;
5. Implanted mechanical tricuspid valve;
6. PR interval greater than 375ms or advanced AV block;
7. In situ S-ICD, pacemaker, or CRT device;
8. Indicated for CRT;
9. End stage renal disease, currently on dialysis, or with other major medical disorder (e.g. liver failure, terminal cancer);
10. Indicated for permanent bradyarrhythmia pacing;
11. Unstable angina pectoris within 30 days prior to study consent;
12. Pregnant or planning to become pregnant during the study;
13. Participating in another cardiac investigational device or drug study at the same time (or within 30 days prior to study consent); Note: Registries and other observational studies are acceptable.
14. Other criteria that preclude Optimizer INTEGRA CCM-D implantation and/or CCM therapy, as determined by Investigator.
18 Years
ALL
No
Sponsors
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Impulse Dynamics
INDUSTRY
Responsible Party
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Principal Investigators
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Niraj Varma, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
The Cleveland Clinic
Nir Uriel, MD
Role: PRINCIPAL_INVESTIGATOR
Columbia University
Locations
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Phoenix Heart
Glendale, Arizona, United States
CardioVascular Associates of Mesa
Mesa, Arizona, United States
Southwest Cardiovascular Associates
Mesa, Arizona, United States
Arizona Heart Rhythm
Phoenix, Arizona, United States
CVC Cardiovascular Consultants
Phoenix, Arizona, United States
Phoenix Heart
Phoenix, Arizona, United States
Honor Health
Scottsdale, Arizona, United States
University of Southern California
Los Angeles, California, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
Aurora Denver Cardiology Associates
Aurora, Colorado, United States
Hartford HealthCare
Hartford, Connecticut, United States
Broward Health Medical Center
Fort Lauderdale, Florida, United States
Baptist Health South Florida
Miami, Florida, United States
Mount Sinai Medical Center Miami Beach
Miami Beach, Florida, United States
Advent Health Orlando
Orlando, Florida, United States
Cleveland Clinic Weston
Weston, Florida, United States
Iowa Heart Center
West Des Moines, Iowa, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Baptist Health Lexington
Lexington, Kentucky, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Saint Luke's Hospital
Kansas City, Missouri, United States
St. Louis VA
St Louis, Missouri, United States
St. Louis Heart and Vascular
St Louis, Missouri, United States
Deborah Heart and Lung Center
Browns Mills, New Jersey, United States
Virtua
Cherry Hill, New Jersey, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
The Heart House - Cardiovascular Associates of the Delaware Valley
Haddon Heights, New Jersey, United States
Rutgers New Jersey Medical School
Newark, New Jersey, United States
NYU Langone
New York, New York, United States
Mount Sinai New York
New York, New York, United States
Columbia University Medical Center / NewYork-Presbyterian
New York, New York, United States
Weill Cornell Medicine
New York, New York, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Sanger Heart and Vascular Institute
Charlotte, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
St. Francis Tulsa
Tulsa, Oklahoma, United States
Portland VA Medical Center
Portland, Oregon, United States
St. Luke's Bethlehem
Bethlehem, Pennsylvania, United States
Bryn Mawr Medical Specialists Association
Bryn Mawr, Pennsylvania, United States
Lancaster General Hospital
Lancaster, Pennsylvania, United States
Penn Presbyterian
Philadelphia, Pennsylvania, United States
Temple University
Philadelphia, Pennsylvania, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Prisma Health
Greenville, South Carolina, United States
Stern Cardiovascular Foundation
Germantown, Tennessee, United States
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, United States
Medical City Dallas
Dallas, Texas, United States
UT Southwestern
Dallas, Texas, United States
Medical City Fort Worth
Fort Worth, Texas, United States
Houston Methodist
Houston, Texas, United States
Houston VA Hospital
Houston, Texas, United States
Christus Trinity Clinic
Tyler, Texas, United States
Centra Health
Lynchburg, Virginia, United States
Chippenham Hospital
Richmond, Virginia, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Seattle VA
Seattle, Washington, United States
Swedish
Seattle, Washington, United States
Countries
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Other Identifiers
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RG_PRO_345
Identifier Type: -
Identifier Source: org_study_id
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