RCT of Implantable Defibrillators in Patients With Non Ischemic Cardiomyopathy, Scar and Severe Systolic Heart Failure

Prior treatment

• Previous implantable device in situ (PPM, Cardiac Resynchronisation Therapy (CRT) or ICD)
• Intracardiac mass which requires surgery
• Active treatment with chemotherapy
• Actively participating in another study without prior agreement between both Chief Investigators

Other illness

• New York Heart Association (NYHA) HF functional class IV after 3 months of optimal medical therapy (OMT)
• Acute decompensated heart failure
• Known diagnosis of amyloidosis, sarcoidosis, arrhythmogenic right ventricular cardiomyopathy, or hypertrophic cardiomyopathy (diseases in which there are specific guidelines regarding defibrillator therapy)
• Known Lamin gene mutation or a positive family history of a Lamin gene mutation
• Valve disease is considered likely to require surgery during the 3 years follow-up period
• Complex congenital heart disease
• Heart transplant recipient or admitted for cardiac transplantation/ left ventricular assist device
• Clinically apparent myocardial ischemia which requires revascularization

Lab values

• Ischemic cardiomyopathy (ICM) is defined as segmental wall motion abnormalities or wall thinning in a particular coronary territory with subendocardial or transmural late gadolinium enhancement (LGE). Patients with an LVEF ≤35% and a small amount of ischemic LGE (i.e. an infarct out of keeping with the amount of LV dysfunction) will not be excluded (so-called dual pathology patients)
• Severe renal failure (GFR \<30)

Age

• Life expectancy \<2 years secondary to any other cause (i.e. malignancy)

Other

• Any secondary prevention ICD indication
• Active endocarditis
• Active Septicaemia
• Pregnancy

• A diagnosis of NICM on contrast-enhanced cardiovascular magnetic resonance imaging
• LV scar on routine CMR (patient without scar can enter the registry)
• New York Heart Association (NYHA) Heart Failure (HF) functional class I-III and severely impaired left ventricular function (LVEF ≤ 35% on any imaging modality) after a minimum of 3 months of treatment with optimal medical therapy (OMT) as recommended by National Institute for Health and Care Excellence (NICE)
• Able and willing to provide informed consent