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

ConditionsAtrioventricular Block Left Bunde Branch Area Pacing Conduction System Pacing

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age19+

SponsorSamsung Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Third-degree AV block

First- or second-degree AV block with an expected ventricular pacing burden ≥40%

Atrial fibrillation with slow ventricular response with an expected ventricular pacing burden ≥40%

Disqualifiers

Prior implantation of a cardiac pacemaker or implantable cardioverter-defibrillator

Left ventricular ejection fraction ≤50%

Indication for cardiac resynchronization therapy

Life expectancy ≤1 year (e.g., patients not eligible for heart transplantation due to end-stage heart failure, patients with DNR orders, those receiving hospice care after refusal of life-sustaining treatment, or patients with terminal cancer not eligible for chemotherapy or radiotherapy)

Trial design

Design model

Parallel

Treatments tested in this trial

Left Bundle Branch Area Pacing
Device
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.
Right venticular pacing
Device
Conventional right ventricular pacing performed with a standard transvenous pacing lead for treatment of atrioventricular block.

Treatment groups

200 Participants

are divided into 2 treatment groups

Group A: Left bundle branch area pacingExperimental treatment 1 intervention

Group B: Right ventricular pacingActive comparator 1 intervention

Trial outcomes