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NCT04730921Completed

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

Impact of Left Bundle Branch Area Pacing vs. Right Ventricular Pacing in Atrioventricular Block (LEAP-Block): A Randomized Controlled Trial

Source: ClinicalTrials.gov · Last updated 30 Dec 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
486 (actual)
First submitted
26 Jan 2021
Start date
13 Nov 2020
Primary completion date
30 Jun 2025
Lead sponsor
Fu Wai Hospital, Beijing, China
NCT number
NCT04730921

What you commit to

  • Study type: Interventional
  • Participants enrolled: 486
  • From 13 Nov 2020 to the primary completion date, 30 Jun 2025
  • 8 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • b. Having difficulties in follow-up: Those who cannot accept 2-year follow-up on time due to physical condition or other reasons;
  • 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 vena cava, etc), or AV block resulting from: (a) Hypertrophic cardiomyopathy(HCM)vpost (modified) Morrow surgery, (b) ventricular septal defect repair; and those who are unlikely to achieve successful LBBAP procedure.

Lab values

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

Other

  • c. Patients with persistent atrial fibrillation;
  • d. Pacemaker replacement without new implanted ventricular electrodes;
  • e. Patients with implantable cardioverter-defibrillator (ICD) indications;

Who the study is looking for

  • a. Adult patients aged 18-90;
  • b. 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 ≥ 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 study centers.
  • f. Subject or authorized legal guardian or representative has signed and dated the study Subject Informed Consent

Age in the registry: 18 years to 90 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (8)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Peking Union Medical College Hospital
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BeijingChinaUnknown status
Beijing Anzhen Hospital, Capital Medical University
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BeijingChinaUnknown status
Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences
Coordinator of this site? Confirm its status
BeijingChinaUnknown status
The Second Hospital of Hebei Medical University
Coordinator of this site? Confirm its status
ShijiazhuangChinaUnknown status
Tianjin Medical University General Hospital
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TianjinChinaUnknown status
TEDA International Cardiovascular Hospital
Coordinator of this site? Confirm its status
TianjinChinaUnknown status
The First Affiliated Hospital of Zhengzhou University
Coordinator of this site? Confirm its status
ZhengzhouChinaUnknown status
Fuwai Central China Cardiovascular Hospital
Coordinator of this site? Confirm its status
ZhengzhouChinaUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.