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.
This is a single centre, prospective, randomized study in which patients with LB-NICM, LVEF ≤35% and heart failure despite guideline directed medical therapy (GDMT) will be included. CMR with gadolinium contrast will be performed to risk categorize the patient into low-risk or high risk based on presence of scar. Low risk patients (without scar ?\<5%) will be randomized in 1:1 fashion to receive either LBBP without defibrillator or traditional CRT-D with biventricular pacing. LBBP will be performed by premature ventricular complex guided approach with 3830 selectsecure lead and C315His sheath in the proximal interventricular septum 1.5-2 cm distal to His bundle. LBB capture will be confirmed as per standard criteria. If LBBP lead implantation is unsuccessful, a coronary sinus lead will be placed to achieve biventricular pacing. In patients randomized to BiV-ICD, left ventricular lead will be placed in the postero-lateral branch of the coronary sinus with Q-LV duration of \>90ms. If coronary sinus lead placement is unsuccessful, a LBBP lead will be implanted. The defibrillator lead will deployed in the right ventricular apical septum.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
114
Capture 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 right ventricular ICD lead and coronary sinus lead. Atrial lead will be positioned in the right atrium
Velammal Medical College Hospital and Research Institute
Madurai, Tamil Nadu, India
RECRUITINGNumber 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
Time frame: 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
Time frame: 6 and 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.