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Search / Trial NCT06023784

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

Launched by PEKING UNION MEDICAL COLLEGE HOSPITAL · Sep 3, 2023

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This clinical trial is designed to compare two different methods of heart pacing in patients with a condition called atrioventricular (AV) block, which affects how electrical signals travel through the heart. The trial will look at the impact of left bundle branch area pacing (LBBAP) versus traditional right ventricular pacing (RVP) on the occurrence of a heart rhythm problem known as atrial fibrillation. Atrial fibrillation can lead to serious complications, so understanding which pacing method is better for preventing it is important.

To participate in this study, you need to be an adult aged 18 to 85 who has AV block and requires ventricular pacing. This includes patients with certain types of AV block that cause slow or irregular heartbeats. However, people with certain heart conditions or a history of atrial fibrillation will not be eligible. If you join the trial, you can expect regular follow-ups over two years to monitor your heart health. This study is not yet recruiting participants, but it aims to provide valuable information about heart pacing methods that could benefit many patients in the future.

Gender

ALL

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.

About Peking Union Medical College Hospital

Peking Union Medical College Hospital (PUMCH) is a prestigious medical institution and a leading research facility located in Beijing, China. Affiliated with the Chinese Academy of Medical Sciences, PUMCH is renowned for its commitment to advancing healthcare through innovative clinical research and high-quality patient care. The hospital plays a pivotal role in the development and execution of clinical trials across various medical disciplines, focusing on improving treatment outcomes and enhancing medical knowledge. With a multidisciplinary team of experts and state-of-the-art facilities, PUMCH is dedicated to contributing to global health advancements and fostering collaborations in the medical research community.

Locations

Beijing, Beijing, China

Patients applied

0 patients applied

Trial Officials

Taibo Chen, PhD.

Study Chair

Peking Union Medical College Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported