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NOT YET RECRUITING
NCT07378124
NA

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

Sponsor: Ningbo No.2 Hospital

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

288

Start Date

2026-01-24

Completion Date

2027-12-31

Last Updated

2026-02-03

Healthy Volunteers

No

Interventions

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.

Locations (1)

Ningbo No.2 Hospital

Ningbo, Zhejiang, China