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
- Diseases
- Heart failure
- 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
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking Union Medical College Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Beijing Anzhen Hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| The Second Hospital of Hebei Medical University Coordinator of this site? Confirm its status | Shijiazhuang | China | Unknown status |
| Tianjin Medical University General Hospital Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
| TEDA International Cardiovascular Hospital Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
| The First Affiliated Hospital of Zhengzhou University Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
| Fuwai Central China Cardiovascular Hospital Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.