NCT07464041

Left Bundle Branch Area Pacing Versus Right Ventricular Pacing in Atrioventricular Block With Preserved Ejection Fraction

Left Bundle Branch Area Pacing With a Stylet-Driven Lead Versus Right Ventricular Pacing in Patients With Atrioventricular Block and Preserved Ejection Fraction: A Multicenter Randomized Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Samsung Medical Center · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

Conventional right ventricular pacing (RVP) has been associated with ventricular dyssynchrony and an increased risk of pacing-induced cardiomyopathy, which may lead to worse clinical outcomes. These adverse effects are more pronounced in patients with pre-existing left ventricular dysfunction. To overcome these limitations, left bundle branch area pacing (LBBAP), which directly engages the cardiac conduction system to preserve physiological ventricular activation, has been increasingly adopted in clinical practice. However, in patients with atrioventricular block and preserved left ventricular ejection fraction (LVEF ≥50%), evidence demonstrating the long-term clinical superiority of LBBAP over conventional RVP remains limited. As a result, both pacing strategies continue to be used in current practice. This multicenter randomized trial aims to compare the efficacy, safety, and lead stability of LBBAP using a stylet-driven extendable screw-in lead versus conventional RVP in patients with atrioventricular block and preserved ejection fraction.

Detailed description

Right ventricular pacing (RVP) has been the conventional pacing strategy for patients requiring permanent pacemaker implantation due to bradyarrhythmias. However, chronic RVP has been shown to induce non-physiological ventricular activation, resulting in ventricular dyssynchrony, an increased incidence of pacing-induced cardiomyopathy, and higher long-term morbidity and mortality. These detrimental effects are particularly evident in patients with impaired baseline cardiac function. Left bundle branch area pacing (LBBAP) has emerged as an alternative physiological pacing strategy that directly captures the cardiac conduction system, thereby preserving synchronized ventricular contraction. Owing to its favorable electrical and hemodynamic characteristics, LBBAP has been increasingly adopted in contemporary clinical practice. Nevertheless, in patients with atrioventricular block and preserved left ventricular ejection fraction (LVEF \>50%), robust evidence demonstrating the long-term clinical benefits of LBBAP compared with conventional RVP is lacking. Consequently, both pacing strategies are currently used interchangeably in real-world practice. Two main types of pacing leads are currently used for LBBAP: lumen-less fixed screw leads (LLFS leads) and stylet-driven extendable screw-in leads (SDES leads). Although several studies have compared short-term clinical outcomes between LBBAP and RVP, the majority of these investigations have utilized LLFS leads. Data evaluating LBBAP performed with SDES leads, particularly in comparison with conventional RVP, remain extremely limited. Therefore, the present multicenter randomized controlled trial is designed to compare the efficacy, safety, and lead stability of LBBAP using a stylet-driven extendable screw-in lead versus conventional right ventricular pacing in patients with atrioventricular block and preserved left ventricular ejection fraction. The findings of this study are expected to provide clinically relevant evidence to guide optimal pacing strategy selection in this patient population.

Conditions

• Atrioventricular Block
• Left Bunde Branch Area Pacing
• Conduction System Pacing

Interventions

Type	Name	Description
DEVICE	Left Bundle Branch Area Pacing	Left bundle branch area pacing performed using a stylet-driven extendable screw-in pacing lead to achieve physiological ventricular activation in patients with atrioventricular block.
DEVICE	Right venticular pacing	Conventional right ventricular pacing performed with a standard transvenous pacing lead for treatment of atrioventricular block.

Timeline

• Start date: 2024-04-29
• Primary completion: 2027-06-30
• Completion: 2027-06-30
• First posted: 2026-03-11
• Last updated: 2026-03-11

Locations

4 sites across 1 country: South Korea