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

Chinese Academy of Medical Sciences & Peking Union Medical College logo

Chinese Academy of Medical Sciences & Peking Union Medical College

Status

Not yet enrolling

Conditions

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

Treatments

Procedure: left bundle branch area pacing
Procedure: right ventricular pacing

Study type

Interventional

Funder types

Other

Identifiers

NCT06023784
the July study

Details and patient eligibility

About

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.

Enrollment

530 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

530 participants in 2 patient groups

left bundle branch area pacing
Experimental group
Treatment:
Procedure: left bundle branch area pacing
right ventricular pacing
Active Comparator group
Treatment:
Procedure: right ventricular pacing

Trial contacts and locations

1

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Central trial contact

Deyan Yang, PhD.

Data sourced from clinicaltrials.gov

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