Key result
Left bundle branch area pacing will be evaluated for superiority against right ventricular pacing in the LEAP trial to prevent mortality, heart failure hospitalization, and LVEF decrease in 470 patients with AV block.
Why the study?
Conventional right ventricular pacing can cause dyssynchronous ventricular activation leading to cardiomyopathy and heart failure, but evidence supporting whether left bundle branch area pacing overcomes these adverse effects is lacking.
Is left bundle branch area pacing superior to right ventricular pacing in preventing the composite of mortality, heart failure hospitalization, and significant LVEF decrease in patients with AV conduction disorders requiring pacing?
RCT (n=470)
Open-label, blinded endpoint evaluation (PROBE)
1:1 block randomization
Yes
Is left bundle branch area pacing superior to right ventricular pacing in preventing the composite of mortality, heart failure hospitalization, and significant LVEF decrease in patients with AV conduction disorders requiring pacing?
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“LBBAP in lieu of RVP for bradycardia is an add-on preventive technique from which the majority of patients will not benefit, because they would never develop pacing-induced cardiomyopathy in the first place. And if at the same time fluoroscopy times are longer and material costs are higher, this does not seem to justify an all-comer approach. Currently, the first randomised clinical trial comparing RVP with LBBAP is underway (LEAP; clinicaltrials.gov NCT04595487), hoping to answer some of these burning questions.”
The LEAP trial is designed to determine if left bundle branch area pacing is superior to traditional right ventricular pacing in preventing mortality, heart failure hospitalization, and pacing-induced cardiomyopathy in patients with AV block.
Permanent cardiac pacing is the only available therapy in patients with atrioventricular (AV) conduction disorders and can be lifesaving. However, conventional right ventricular pacing (RVP) causes dyssynchronous electrical and mechanical activation of the ventricles, possibly resulting in pacing-induced cardiomyopathy and heart failure. Left bundle branch area pacing (LBBAP) might overcome these adverse effects of RVP, but evidence to support this assumption is lacking. The LEAP trial is a multi-centre investigator-initiated, prospective, randomized controlled, open-label, blinded endpoint evaluation (PROBE) study, designed to test the hypothesis that in patients with an indication for pacemaker implantation due to AV conduction disorders with an expected ventricular pacing percentage ≥20%. LBBAP is superior to RVP in preventing the composite primary endpoint of (1) all-cause mortality, (2) hospitalization for heart failure, and (3) a more than 10% point decrease in left ventricular ejection fraction (LVEF) leading to an LVEF below 50%. The LEAP trial randomizes 470 patients 1:1 to the index LBBAP or RVP control arm. The primary endpoint will be determined at 1-year follow-up. This article describes the design and analytic plan for the trial.
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Rijks et al. (2026) conducted an RCT in Atrioventricular conduction disorders (n=470). Left bundle branch area pacing (LBBAP) vs. Right ventricular pacing (RVP) was evaluated on Composite of all-cause mortality, hospitalization for heart failure, and a >10% point decrease in LVEF leading to an LVEF <50% at 1-year follow-up. Left bundle branch area pacing will be evaluated for superiority against right ventricular pacing in the LEAP trial to prevent mortality, heart failure hospitalization, and LVEF decrease in 470 patients with AV block.
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