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

Peking Union Medical College Hospital1 site in 1 country530 target enrollmentSeptember 30, 2023

ConditionsLeft Bundle Branch Area Pacing Right Ventricular Pacing Atrioventricular Block Atrial Fibrillation

Overview

Phase: N/A
Intervention: Not specified
Conditions: Left Bundle Branch Area Pacing
Sponsor: Peking Union Medical College Hospital
Enrollment: 530
Locations: 1
Primary Endpoint: the incidence of new-onset atrial fibrillation
Status: Not Yet Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 30, 2023

End Date

December 31, 2030

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Peking Union Medical College Hospital

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

the incidence of new-onset atrial fibrillation

Time Frame: within two years after device implantation

Secondary Outcomes

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)