None listed
Conditions
Brief summary
This study aims at evaluating effect of LBBAP on clinical outcomes in comparison to RVP which has been a gold standard for six decades. The study hypothesis is that the LBBAP is more effective for pacing in patients with mild LV dysfunction or normal LV function. The study is aimed at evaluating LBBAP's efficacy in patients with LVEF >35%. Primary outcome measure is effect on LVEF. Secondary outcome measures include incidence of heart failure hospitalization, new onset atrial fibrillation and evaluation of structural changes in heart. The minimum follow up in this trial was 1 year.
Interventions
Left bundle branch area pacing (LBBAP) will be studied. LBBAP involves implanting the pacing lead in the left bundle branch (LBB) or left ventricular septal location. The intervention will be performed in pacing indicated patients randomized to LBBAP arm. In LBBAP, the ventricular lead is implanted deep in the septum to capture LBB or left ventricular septum (LVS). The final location of the lead is determined based on electrocardiographic criteria as below:
Paced RBBB morphology plus at least
Left bundle branch area pacing (LBBAP) will be studied. LBBAP involves implanting the pacing lead in the left bundle branch (LBB) or left ventricular septal location. The intervention will be performed in pacing indicated patients randomized to LBBAP arm. In LBBAP, the ventricular lead is implanted deep in the septum to capture LBB or left ventricular septum (LVS). The final location of the lead is determined based on electrocardiographic criteria as below: Paced RBBB morphology plus at least one of the following: 1. R wave peak time in lead V6 <80 ms in patients with a bundle branch block and <75 ms in patients with narrow complex QRS 2. Transition from non-selective to selective LBB or left ventricular septal capture seen 3. V6-V1 interval <44 ms The intervention will be performed by cardiac electrophysiologist with >5 years of experience in implanting LBBAP pacemaker. The intervention will be performed only once during the study unless lead failure or infection mandates lead revision/removal. The intervention will be performed at National Capital Private Hospital. The usual duration to perform this LBBAP implant is 60-90 mins. ECGs will be done at each follow up to monitor persistence of LBB/LVS capture.
Sponsors
Canberra heart rhythm
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age: above 18 years 2. AV block or any other bradyarrhythmia with pacing burden of >40% 3. Left ventricular ejection fraction (LVEF) >35%
Exclusion criteria
1. LVEF <35% 2. Patients with biventricular pacing 3. Patients with structural heart disease 4. Patients with alternative pathology which can cause LV dysfunction, such as severe MR, severe AS or AR 5. Patients with atrial fibrillation 6. Patients for ‘pace and ablate’ therapy 7. Patients being considered for epicardial pacing 8. Patients refused to provide consent 9. Limited life expectancy due to comorbidity
Outcome results
None listed