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

Last updated: December 26, 2025
Sponsor: Fu Wai Hospital, Beijing, China
Overall Status: Completed

Phase

N/A

Condition

Chest Pain

Heart Failure

Congestive Heart Failure

Treatment

Right ventricular pacing

Left bundle branch area pacing

Clinical Study ID

NCT04730921
2020-1379
  • Ages 18-90
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • a. Adult patients aged 18-90;

  • b. AV block patients with ventricular pacing indications and the expected rate ofventricular pacing(VP)> 40%, including (a)Third-degree AV block; (b) Second degreeAV block (type II); (c) intermittent advanced AV block with expected VP>40%; (d)Symptomatic first degree AV block and PR interval on ECG ≥ 250ms;

  • c. The subject is able to receive a pectoral implant;

  • d. The subject is willing and able to comply with the protocol;

  • e. The subject is expected to remain available for follow-up visits at the studycenters.

  • f. Subject or authorized legal guardian or representative has signed and dated thestudy Subject Informed Consent

Exclusion

Exclusion Criteria:

  • a. Baseline echocardiographic assessment of patients with impaired LV function (LVEF<50%);

  • b. Having difficulties in follow-up: Those who cannot accept 2-year follow-up ontime due to physical condition or other reasons;

  • c. Patients with persistent atrial fibrillation;

  • d. Pacemaker replacement without new implanted ventricular electrodes;

  • e. Patients with implantable cardioverter-defibrillator (ICD) indications;

  • f. Surgery is required within 1 year due to severe structural heart disease;

  • g. Patients with tricuspid mechanical valve replacement, or congenital heart disease (including transposition of the great arteries, or permanent left superior venacava, etc), or AV block resulting from: (a) Hypertrophic cardiomyopathy(HCM)vpost (modified) Morrow surgery, (b) ventricular septal defect repair; and those who areunlikely to achieve successful LBBAP procedure.

Study Design

Total Participants: 486
Treatment Group(s): 2
Primary Treatment: Right ventricular pacing
Phase:
Study Start date:
November 13, 2020
Estimated Completion Date:
December 01, 2025

Study Description

LEAP-BLOCK is a prospective, multi-center, randomized controlled trial that is designed to determine whether left bundle branch area pacing (LBBAP) may reduce the risk of RV ventricular pacing induced cardiac dysfunction as compared with traditional RV pacing (RVP) in patients with atrioventricular (AV) block and normal LV function (LVEF≥50%) who require high percent of ventricular pacing. The primary aim of this trial is to compare the time to first event (composite of all-cause mortality and newly heart failure hospitalization and device upgrade due to heart failure) between LBBAP and RVP group in patients with AV block. Patients with AV block and normal LV function who require high burden of ventricular pacing (expected >40%) will be randomized to LBBAP or RVP group for therapy. Patients will be followed at least every 3 months for clinical status and every 6 months for echocardiographic evaluation until the study closure.

Connect with a study center

  • Beijing Anzhen hospital, Capital Medical University

    Beijing, Beijing 100029
    China

    Site Not Available

  • Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences

    Beijing, Beijing 100037
    China

    Active - Recruiting

  • Peking Union Medical College Hospital

    Beijing, Beijing 100730
    China

    Site Not Available

  • Beijing Anzhen hospital, Capital Medical University

    Beijing 1816670, Beijing Municipality 2038349 100029
    China

    Site Not Available

  • Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences

    Beijing 1816670, Beijing Municipality 2038349 100037
    China

    Site Not Available

  • Peking Union Medical College Hospital

    Beijing 1816670, Beijing Municipality 2038349 100730
    China

    Site Not Available

  • The Second Hospital of Hebei Medical University

    Shijiazhuang, Hebei
    China

    Site Not Available

  • The Second Hospital of Hebei Medical University

    Shijiazhuang 1795270, Hebei 1808773
    China

    Site Not Available

  • Fuwai Central China Cardiovascular Hospital

    Zhengzhou, Henan 450003
    China

    Site Not Available

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan 450052
    China

    Site Not Available

  • Fuwai Central China Cardiovascular Hospital

    Zhengzhou 1784658, Henan 1808520 450003
    China

    Site Not Available

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou 1784658, Henan 1808520 450052
    China

    Site Not Available

  • Teda International Cardiovascular Hospital

    Tianjin, Tianjin
    China

    Site Not Available

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin 300052
    China

    Site Not Available

  • Teda International Cardiovascular Hospital

    Tianjin 1792947, Tianjin Municipality 1792943
    China

    Site Not Available

  • Tianjin Medical University General Hospital

    Tianjin 1792947, Tianjin Municipality 1792943 300052
    China

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.