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

Not Applicable

Not yet recruiting

• Conditions: Left Bundle Branch Area Pacing; Atrioventricular Block; Atrial Fibrillation; Right Ventricular Pacing
• Interventions: Procedure: left bundle branch area pacing; Procedure: right ventricular pacing

• Registration Number: NCT06023784
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-07
• Study First Submitted: 2023-08-24
• Study First Submitted QC: 2023-09-03
• Last Update Submitted: 2023-09-03
• Study First Posted: 2023-09-05
• Last Update Posted: 2023-09-05
• Study Start: 2023-09-30
• Primary Completion: 2028-12-31
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 530

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
left bundle branch area pacing	left bundle branch area pacing	-
right ventricular pacing	right ventricular pacing	-

Primary Outcome Measures

Name	Time	Method
the incidence of new-onset atrial fibrillation	within two years after device implantation

Secondary Outcome Measures

Name	Time	Method
an device upgrade for heart failure	within two years after device implantation
all-cause mortality	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
hospitalization for heart failure	within two years after device implantation

Trial Locations

Locations (1)

Chinese Academy of Medical Sciences & Peking Union Medical College, Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China