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

Launched by FU WAI HOSPITAL, BEIJING, CHINA · Jan 26, 2021

Keywords

ClinConnect Summary

The LEAP-Block trial is studying two different ways to pace the heart in patients with a condition called atrioventricular block, which can cause the heart to beat irregularly. The researchers want to see if a newer method called Left Bundle Branch Area Pacing (LBBAP) is better for heart function compared to the traditional Right Ventricular Pacing (RVP). This study is important because improving heart function can help patients feel better and live healthier lives.

To participate, individuals must be adults aged 18-90 with specific types of atrioventricular block that require ventricular pacing, which means their hearts need help to maintain a proper rhythm. Participants should also be able to have a small device implanted under their skin and agree to follow up with the study team over two years. Throughout the trial, participants can expect regular check-ups and monitoring to see how their heart is responding to the different pacing methods. It’s crucial for potential participants to know that those with certain heart conditions or who might not be able to attend follow-up appointments may not be eligible for this study.

Gender

ALL

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.