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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorNingbo No.2 Hospital

About this 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.

Eligibility criteria

Qualifiers

Symptomatic sick sinus syndrome (SSS);

Complete or advanced atrioventricular block (AVB);

Patients with heart failure complicated by left bundle branch block (LBBB) and biventricular dyssynchrony;

Patients with atrial fibrillation (AF) complicated by refractory rapid ventricular rate who are scheduled for atrioventricular node ablation and permanent pacemaker implantation;

Disqualifiers

Patients who are ineligible for transvenous cardiac pacemaker implantation due to anatomical abnormalities, infections, or other factors;

Patients with existing implantable cardiac electronic devices (ICEDs);

Patients who opt for right-sided venous access for any reason;

Patients with an expected survival of less than 1 year;

Trial design

Treatments tested in this trial

  • SDL implantation
  • LLL implantation

Treatment groups

288 Participants
are divided into 2 treatment groups

Sponsors and collaborators