This randomized study aimed to compare the efficacy of LBBP without defibrillator vs biventricular pacing with defibrillator (BiV-ICD/CRT-D) in patients with LB-NICM and left ventricular ejection fraction (LVEF) ≤35% risk categorized by CMR imaging.
Patients with age ≥18 years
Typical left bundle branch block as defined by Strauss criteria with LVEF ≤35%
Heart failure symptoms despite guideline directed medical therapy (GDMT)
Patients with angiographic evidence of significant coronary artery disease requiring revascularisation. In patients with significant CAD, LVEF will be re-assessed 3 months after revascularisation to decide about CRT
Patients with associated uncorrected congenital or valvular heart disease
Expected life-expectance of <12 months due to associated comorbidities
Patients with contrast allergy
Parallel
left bundle branch pacing
DeviceCapture of left bundle branch fibers by positioning the lead deep inside the proximal inter ventricular septum. Atrial lead will positioned in the right atrium
Biventricular pacing with defibrillator
DeviceBiventricular pacing with right ventricular ICD lead and coronary sinus lead. Atrial lead will be positioned in the right atrium
Number of participants with the following treatment related events in each arm
1. Composite of occurrence 1. death, 2. HFH, or 3. sustained VT at 12 months 2. Echocardiographic response (ER) defined as absolute increase in LVEF by \>15% at 12 months
Number of participants with the following treatment related events in each arm
1. Echocardiographic hyper-response (EHR) defined as normalisation of LVEF (≥50%) at 6 and 12 months 2. Need for ICD upgrade (persistent LVEF \<35% or sustained VT/VF) at 12 months
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