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Clinical Trials in the USA / NCT05855135
Active, not recruiting Not applicable

Assessment of Combined CCM and ICD Device in HFrEF

NCT05855135 · tracked via the Priya Life Science USA tracker
Sponsor
Impulse Dynamics
Phase
Not applicable
Started
2023-05-17
Last updated
2026-05-27

Condition(s) studied

Heart FailureHeart Failure With Reduced Ejection FractionImplantable Defibrillator UserCCM TherapyNon-ischemic CardiomyopathyIschemic CardiomyopathySudden Cardiac ArrestArrhythmias, CardiacVentricular TachycardiaVentricular Fibrillation

Investigational drug(s) / intervention(s)

OPTIMIZER® Integra CCM-D System (Treatment Arm)

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.

Study summary

The goal of this clinical trial is to demonstrate that the OPTIMIZER® Integra CCM-D System (the "CCM-D System") can safely and effective convert induced ventricular fibrillation (VF) and spontaneous ventricular tachycardia and/or ventricular fibrillation (VT/VF) episodes in subjects with Stage C or D heart failure who remain symptomatic despite being on guideline-directed medical therapy (GDMT), are not indicated for cardiac resynchronization therapy (CRT), and have heart failure with reduced left ventricular ejection fraction (LVEF ≤40%).

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: Individuals must meet all the following: 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: An individual who meets any of the following criteria will be excluded from participation in this study: 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.

Primary outcome measure(s)

Trial sites (59)

FacilityCityRegionStatus
Phoenix Heart Glendale Arizona
CardioVascular Associates of Mesa Mesa Arizona
Southwest Cardiovascular Associates Mesa Arizona
Arizona Heart Rhythm Phoenix Arizona
CVC Cardiovascular Consultants Phoenix Arizona
Phoenix Heart Phoenix Arizona
Honor Health Scottsdale Arizona
University of Southern California Los Angeles California
Cedars Sinai Medical Center Los Angeles California
Hartford HealthCare Hartford Connecticut
Broward Health Medical Center Fort Lauderdale Florida
Baptist Health South Florida Miami Florida
Mount Sinai Medical Center Miami Beach Miami Beach Florida
Advent Health Orlando Orlando Florida
Iowa Heart Center West Des Moines Iowa
University of Kansas Medical Center Kansas City Kansas
Baptist Health Lexington Lexington Kentucky
Massachusetts General Hospital Boston Massachusetts
Saint Luke's Hospital Kansas City Missouri
St. Louis VA St Louis Missouri
St. Louis Heart and Vascular St Louis Missouri
Deborah Heart and Lung Center Browns Mills New Jersey
Virtua Cherry Hill New Jersey
Hackensack University Medical Center Hackensack New Jersey
The Heart House - Cardiovascular Associates of the Delaware Valley Haddon Heights New Jersey
Rutgers New Jersey Medical School Newark New Jersey
NYU Langone New York New York
Mount Sinai New York New York New York
Columbia University Medical Center / NewYork-Presbyterian New York New York
Weill Cornell Medicine New York New York
University of North Carolina Chapel Hill North Carolina
Sanger Heart and Vascular Institute Charlotte North Carolina
Louis Stokes Cleveland VA Medical Center Cleveland Ohio
Cleveland Clinic Cleveland Ohio
The Ohio State University Wexner Medical Center Columbus Ohio
St. Francis Tulsa Tulsa Oklahoma
Portland VA Medical Center Portland Oregon
St. Luke's Bethlehem Bethlehem Pennsylvania
Bryn Mawr Medical Specialists Association Bryn Mawr Pennsylvania
Lancaster General Hospital Lancaster Pennsylvania

+ 19 more sites — see the full list on the official registry below.

More Impulse Dynamics trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05855135 on ClinicalTrials.gov ↗ ← All trials in the USA