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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
SDL implantation
Procedure/SurgeryImplantation 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
Procedure/SurgeryImplantation 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.
Treatment groups
288 Participants
are divided into 2 treatment groupsGroup A: SDL groupExperimental treatment 1 intervention
Group B: LLL groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
The primary efficacy endpoint
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.
Time frame
During the LBBP procedure2
The primary safety endpoint
The primary safety endpoint is defined as a composite endpoint consisting of the following anticipated procedure-related serious adverse events (SAEs).
Time frame
From start of the procedure to the end of follow-up at 6 monthsSecondary outcomes
1
Procedural success rate
The procedural success rate, defined as completion of LBB lead implantation in the interventricular septum, meets the criteria for left bundle branch area pacing as defined in current guidelines. Although S-V dissociation is not achieved, at least two visualized indicators are observed when the pacing output is set at ≤2 V/0.5 ms.
Time frame
During the procedure.2
Abnormal parameters detected during follow-up
Clinically significant abnormalities in pacing lead parameters detected during pacemaker programming throughout the follow-up period.
Time frame
From the start of procedure to the end of follow-up at 6 months3
Assessment of cardiac function during follow-up
Postoperative occurrence of pacemaker-related heart failure or progression of pre-existing cardiac insufficiency.
Time frame
From the start of procedure to the end of follow-up at 6 months4
Assessment of quality of life.
Changes in subjects' quality of life (assessed by the multipurpose short-form \[SF-12\] Health Survey Score). The SF-12 scale assesses eight health domains. Its standardized scores range from 0 to 100, and a higher total score indicates better overall health status.
Time frame
From the start of procedure to the end of follow-up at 6 monthsSponsors and contacts
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Source ClinicalTrials.gov
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