Assessment of Combined CCM and ICD Device in HFrEF

Running, not enrolling · Not applicable

Conditions studied: Heart Failure, Heart Failure With Reduced Ejection Fraction, Implantable Defibrillator User, CCM Therapy, Non-ischemic Cardiomyopathy, Ischemic Cardiomyopathy, Sudden Cardiac Arrest, Arrhythmias, Cardiac, Ventricular Tachycardia, Ventricular Fibrillation

In brief

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.

Key facts

Study ID

NCT05855135

Run by

Impulse Dynamics

People needed

300

Starts

2023-05-17

Expected to finish

2027-07-01

Last updated by the study team

2026-05-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Individuals must meet all the following:
• Patient is aged 18 years or older;
• Patient meets the Stage C or D criteria of the Universal Definition of Heart Failure ;
• Patient has HFrEF (LVEF ≤40%);
• Patient is on GDMT for heart failure;
• Patient has a Class I or Class II indication for an ICD
• Patient has a reasonable expectation of meaningful survival of > 1 year;
• Patient has either non-ischemic cardiomyopathy or ischemic cardiomyopathy and is at least 40 days post-MI, if an MI occurred;
• 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.

You may not qualify if…

• An individual who meets any of the following criteria will be excluded from participation in this study:
• Patients should not have severe AI or AS, and should not have MS; additionally, patients undergoing DE testing should not have severe MR;
• Patients who have undergone mitral valve repair or clip within 90 days prior to study consent;
• Cardiac surgery within 90 days or a PCI procedure within 30 days prior to study consent;
• Prior heart transplant or ventricular assist device;
• Implanted mechanical tricuspid valve;
• PR interval greater than 375ms or advanced AV block;
• In situ S-ICD, pacemaker, or CRT device;
• Indicated for CRT;
• End stage renal disease, currently on dialysis, or with other major medical disorder (e.g. liver failure, terminal cancer);
• Indicated for permanent bradyarrhythmia pacing;
• Unstable angina pectoris within 30 days prior to study consent;
• Pregnant or planning to become pregnant during the study;
• 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.
• Other criteria that preclude Optimizer INTEGRA CCM-D implantation and/or CCM therapy, as determined by Investigator.

Where it is running

• 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
• 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
• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.