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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
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.
Age
All ages
Sex
ALL
Healthy Volunteers
No
Ningbo No.2 Hospital
Ningbo, Zhejiang, China
Start Date
January 24, 2026
Primary Completion Date
June 30, 2027
Completion Date
December 31, 2027
Last Updated
February 3, 2026
288
ESTIMATED participants
SDL implantation
PROCEDURE
LLL implantation
PROCEDURE
Lead Sponsor
Ningbo No.2 Hospital
NCT07221682
NCT03008291
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT07290595