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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

Study 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.

Eligibility

Primary outcome measure(s)

• The primary efficacy endpoint — During the LBBP procedure
  The primary efficacy endpoint is defined as the success rate of intraoperative implantation of the left bundle branch lead with the documentation of S-V dissociation.
• The primary safety endpoint — From start of the procedure to the end of follow-up at 6 months
  The primary safety endpoint is defined as a composite endpoint consisting of the following anticipated procedure-related serious adverse events (SAEs).

Trial sites (1)

More Ningbo No.2 Hospital trials in China

Other trials for the same condition