Clinical Trial

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

Study acronym: NOVEL II
Active, Not Recruiting
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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.
Protocol Amendment History 3 changes
critical Enrollment closed, study ongoing 2026-07-29
notable Primary completion pushed: 2027-06-30 -> 2027-08-18 2026-07-29
minor Completion pushed: 2027-06-30 -> 2029-08-18 2026-07-29
Trial Details
NCT Number NCT07464041
Lead Sponsor Samsung Medical Center
Conditions Atrioventricular Block, Left Bunde Branch Area Pacing, Conduction System Pacing
Enrollment 200 participants
Start Date 2024-04-29
Primary Completion 2027-08-18 (estimated)
Study Completion 2029-08-18 (estimated)
Updated on ClinicalTrials.gov 2026-07-28