Impact of Left Bundle Branch Area Pacing vs. Right Ventricular Pacing in Atrioventricular Block (LEAP-Block)

NCT04730921 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 486

Last updated 2025-12-30

No results posted yet for this study

Summary

This is a multicenter, randomized controlled study. The aim of this study is to compare the impact of LBBAP on left ventricular function as compared with traditional right ventricular pacing in patients with atrioventricular block.

Conditions

  • Atrioventricular Block
  • Left Bundle Branch Area Pacing
  • Right Ventricular Pacing
  • Heart Failure

Interventions

DEVICE

Left bundle branch area pacing

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.

DEVICE

Right ventricular pacing

Right ventricular pacing is the traditional pacing modality for ventricular pacing. The pacing lead was placed in the apex or septum of right ventricle.

Sponsors & Collaborators

  • Beijing Anzhen Hospital

    collaborator OTHER
  • The First Affiliated Hospital of Zhengzhou University

    collaborator OTHER
  • The Second Hospital of Hebei Medical University

    collaborator OTHER
  • Chinese Academy of Medical Sciences, Fuwai Hospital

    collaborator OTHER
  • Tianjin Medical University General Hospital

    collaborator OTHER
  • TEDA International Cardiovascular Hospital

    collaborator OTHER
  • Peking Union Medical College Hospital

    collaborator OTHER
  • Chinese Society of Cardiology

    collaborator OTHER
  • Affiliated Hospital of Qinghai University

    collaborator OTHER
  • Shanxi Cardiovascular Hospital

    collaborator OTHER
  • First Affiliated Hospital of Chongqing Medical University

    collaborator OTHER
  • Peking University First Hospital

    collaborator OTHER
  • Beijing Friendship Hospital

    collaborator OTHER
  • Wuxi People's Hospital

    collaborator OTHER
  • Fu Wai Hospital, Beijing, China

    lead OTHER

Principal Investigators

  • Xiaohan Fan, PhD. · Chinese Academy of Medical Sciences, Fuwai Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-13
Primary Completion
2025-06-30
Completion
2025-12-01
FDA Device
Yes

Countries

  • China

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04730921 on ClinicalTrials.gov