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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
300
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.
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
Device Effectiveness in Converting Induced Ventricular Fibrillation (Primary Efficacy Objective)
Evaluate the device effectiveness in converting induced VF at the time of implantation.
Time frame: Implant
Device-related Complications (Primary Safety Objective)
Evaluate device-related complications through 6-months (excluding lead-related complications).
Time frame: Implant to 6 months
Inappropriate Shock Rate out to 6-months (Secondary Safety Objective)
Evaluate the incidence of inappropriate ICD shocks through the time when the last subject enrolled completes the 6-month visit.
Time frame: Implant to 6 months
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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
...and 49 more locations