Status:
COMPLETED
Impact of Left Bundle Branch Area Pacing vs. Right Ventricular Pacing in Atrioventricular Block (LEAP-Block)
Lead Sponsor:
Fu Wai Hospital, Beijing, China
Collaborating Sponsors:
Beijing Anzhen Hospital
The First Affiliated Hospital of Zhengzhou University
Conditions:
Atrioventricular Block
Left Bundle Branch Area Pacing
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief 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 patien...
Detailed 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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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 on time 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 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.
Key Trial Info
Start Date :
November 13 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2025
Estimated Enrollment :
486 Patients enrolled
Trial Details
Trial ID
NCT04730921
Start Date
November 13 2020
End Date
December 1 2025
Last Update
December 30 2025
Active Locations (8)
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1
Beijing Anzhen hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100029
2
Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100037
3
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730
4
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China