The Impact of LBBAP vs RVP on the Incidence of New-onset Atrial Fibrillation in Patients With Atrioventricular Block

Study Overview
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Brief Summary
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This is a single-center, randomized controlled study. The aim of this study is to compare the impact of left bundle branch area pacing versus traditional right ventricular pacing on the incidence of atrial fibrillation in patients with atrioventricular block.

Official Title
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The Impact of Left Bundle Branch Area Pacing Versus Right Ventricular Pacing on the Incidence of New-onset Atrial Fibrillation in Patients With Atrioventricular Block: a Randomized Controlled Trial

Conditions
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Left Bundle Branch Area Pacing, Right Ventricular Pacing, Atrioventricular Block, Atrial Fibrillation

Intervention / Treatment
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* Procedure: left bundle branch area pacing
* Procedure: right ventricular pacing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients aged 18-85; AV block patients with ventricular pacing indications and the expected rate of ventricular pacing(VP)> 40%, including (a) third-degree AV block; (b) second degree AV block (type II); (c) intermittent advanced AV block with expected VP>40%; (d) symptomatic first degree AV block and PR interval on ECG > 300ms; Signed informed consent; Exclusion Criteria: Baseline echocardiographic assessment of patients with impaired LV function (LVEF<50%); Patients with the history of atrial fibrillation; Having difficulties in follow-up: Those who cannot accept 2-year follow-up on time due to physical condition or other reasons; Pacemaker replacement without new implanted ventricular electrodes; Surgery is required within 1 year due to severe structural heart disease; Patients with tricuspid mechanical valve replacement, or congenital heart disease (including transposition of the great arteries, or permanent left superior vena cava, etc); AV block resulting from: (a) Hypertrophic cardiomyopathy(HCM), (b) ventricular septal defect repair, and those who are unlikely to achieve successful LBBAP procedure.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: left bundle branch area pacing<br> | Procedure: left bundle branch area pacing<br>* Left bundle branch area pacing(LBBAP) is a novel physiological pacing form for ventricular pacing. In patients received LBBAP, the pacing lead will be placed at left bundle branch area to achieve narrow paced QRS duration.<br>|
| Active Comparator: right ventricular pacing<br> | Procedure: right ventricular pacing<br>* Right ventricular pacing is the traditional pacing modality for ventricular pacing. The pacing lead was placed in the apex or septum of right ventricle.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the incidence of new-onset atrial fibrillation |  | within two years after device implantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all-cause mortality |  | within two years after device implantation | 
| hospitalization for heart failure |  | within two years after device implantation | 
| an device upgrade for heart failure |  | within two years after device implantation | 
| alteration of quality of life score |  | within two years after device implantation | 
| Improvement of left ventricular, right ventricular and left atrial function measured by echocardiography |  | within two years after device implantation | 
| pacemaker-associated cardiomyopathy |  | within two years after device implantation |