NCT07378124

LLL vs. SDL for LBBP: A Non-inferiority RCT

Efficacy and Safety Comparison of Lumenless Lead Versus Stylet-driven Lead in Intraoperative Application of Left Bundle Branch Pacing Guided by Continuous Pacing Monitoring With S-V Dissociation as the Primary Outcome: A Non-inferiority, Multicenter, Prospective Randomized Controlled Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 288 (estimated)
• Sponsor: Ningbo No.2 Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Left Bundle Branch Pacing (LBBP) has emerged as one of the most commonly used physiological pacing modalities in clinical practice. However, the key determinants of procedural success lie in the accurate intraoperative identification of proper LBB lead positioning and the prevention of cardiac perforation. Our previous research has established a methodology for Lumenless Lead (LLL) implantation under the guidance of continuous pacing monitoring, and this methodology has been further adapted for Stylet-driven Lead (SDL) implantation. The present study is designed as a multicenter, randomized controlled trial, aiming to compare the differences in efficacy and safety between LLL and SDL during LBBP procedures guided by continuous pacing monitoring, with the presence of S-V dissociation serving as the criterion for confirming optimal LBB lead positioning.

Conditions

• Bradycardia
• Conduction Block, Atrioventricular

Interventions

Type	Name	Description
PROCEDURE	SDL implantation	Implantation of an SDL during LBBP procedures guided by continuous pacing monitoring, with the presence of S-V dissociation serving as the criterion for confirming optimal LBB lead positioning.
PROCEDURE	LLL implantation	Implantation of an LLL during LBBP procedures guided by continuous pacing monitoring, with the presence of S-V dissociation serving as the criterion for confirming optimal LBB lead positioning.

Timeline

• Start date: 2026-01-24
• Primary completion: 2027-06-30
• Completion: 2027-12-31
• First posted: 2026-01-30
• Last updated: 2026-02-03

Locations

1 site across 1 country: China