Study Comparing Left Bundle Branch Pacing and Right Ventricular Pacing on Atrial High-Rate Episode Duration in Patients with Normal Heart Pump Function and Need for Frequent Ventricular Pacing

What this Trial Is About

Researchers are evaluating left bundle branch pacing LBBP compared with conventional right ventricular RV pacing in patients who have preserved left ventricular ejection fraction LVEF above 50% and require frequent ventricular pacing due to atrioventricular AV conduction disorders. This randomized controlled trial aims to study the total time of atrial high-rate episodes AHREs, which are episodes of fast heart rhythm detected by implanted devices and linked to risks like atrial fibrillation and thromboembolic events. The study focuses on whether LBBP can reduce AHRE burden better than RV pacing by providing more natural heart activation. Participants are randomly assigned to receive either a dual-chamber pacemaker with the ventricular lead placed in the right ventricular septum or with the lead placed at the left bundle branch area. The devices are commercially available and programmed for physiological pacing. Researchers will monitor pacing percentages and configurations during follow-up visits. The study period lasts 24 months from pacemaker implantation or randomization, during which various episode durations and clinical events will be recorded. During the study, participants will undergo device diagnostics to detect AHREs, with a portion of episodes reviewed to confirm their atrial origin and exclude false readings. Safety events, hospitalizations, changes in heart function, biomarkers, and quality of life will be assessed at multiple time points up to two years. The primary outcome is the total cumulative AHRE time for episodes lasting more than six minutes. This comprehensive monitoring and follow-up will help determine the impact of pacing type on atrial arrhythmias and related health outcomes.

Left Bundle Branch Pacing vs Right Ventricular Pacing on AHRE Burden in Patients With Preserved LVEF