Comparing Left Bundle Branch Area Pacing and Right Ventricular Pacing in Heart Block

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

This study is testing whether a new way of pacing the heart called left bundle branch area pacing can help people with heart block have better heart function compared to the traditional method of pacing.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 458 (estimated)
• Ages: 18 Years to 90 Years
• Sex: All
• Sponsor: Fu Wai Hospital, Beijing, China (Academic / other)
• Locations: 8 sites (Beijing, Beijing and 7 other locations)
• Trial ID: NCT04730921 on ClinicalTrials.gov

What this trial studies

This multicenter, randomized controlled trial aims to evaluate the effects of left bundle branch area pacing (LBBAP) versus traditional right ventricular pacing (RVP) on left ventricular function in patients with atrioventricular block. The study will enroll adult patients who require a high percentage of ventricular pacing and have normal left ventricular function. Participants will be randomly assigned to receive either LBBAP or RVP, and their clinical outcomes will be monitored over a period of at least two years. The primary endpoint is the time to the first event, which includes all-cause mortality and heart failure-related hospitalizations.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-90 with atrioventricular block requiring more than 40% ventricular pacing and normal left ventricular function.

Not a fit: Patients with impaired left ventricular function or persistent atrial fibrillation may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved heart function and reduced hospitalizations for patients with atrioventricular block.

How similar studies have performed: Previous studies have shown promising results with left bundle branch area pacing, suggesting potential benefits over traditional pacing methods.

Eligibility criteria

Inclusion Criteria:

* 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 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 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.

Where this trial is running

Beijing, Beijing and 7 other locations

• Beijing Anzhen hospital, Capital Medical University — Beijing, Beijing, China (Not_yet_recruiting)
• Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences — Beijing, Beijing, China (Recruiting)
• Peking Union Medical College Hospital — Beijing, Beijing, China (Not_yet_recruiting)
• The Second Hospital of Hebei Medical University — Shijiazhuang, Hebei, China (Not_yet_recruiting)
• Fuwai Central China Cardiovascular Hospital — Zhengzhou, Henan, China (Not_yet_recruiting)
• The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (Not_yet_recruiting)
• Tianjin Medical University General Hospital — Tianjin, Tianjin, China (Not_yet_recruiting)
• Teda International Cardiovascular Hospital — Tianjin, Tianjin, China (Not_yet_recruiting)

Study contacts

• Study coordinator: Xiaofei Li, M.D.

Conditions Atrioventricular Block; Left Bundle Branch Area Pacing; Right Ventricular Pacing; Heart Failure; Left bundle branch area pacing; Right ventricular pacing