assessment of combined ccm and icd device in hfref

Conditions: 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

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 criteria:
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.

Keywords: heart failure hfref stage c heart failure stage d heart failure defibrillation efficacy testing induced ventricular fibrillation ventricular fibrillation ventricular tachycardia implantable cardioverter defibrillator sudden cardiac arrest