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
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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