Bradycardia, Conduction Block, Atrioventricular
Conditions
Brief 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.
Interventions
PROCEDURESDL 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.
PROCEDURELLL 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.
Sponsors
Ningbo No.2 Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* 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; * Other patients who meet the indications for dual-chamber pacemaker implantation as specified in current guidelines
Exclusion criteria
* 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; * Patients who have been enrolled in other clinical trials related to implantable cardiac electronic devices within 3 months prior to enrollment in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedural success rate | During the procedure. | 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. |
| Abnormal parameters detected during follow-up | From the start of procedure to the end of follow-up at 6 months | Clinically significant abnormalities in pacing lead parameters detected during pacemaker programming throughout the follow-up period. |
| Assessment of cardiac function during follow-up | From the start of procedure to the end of follow-up at 6 months | Postoperative occurrence of pacemaker-related heart failure or progression of pre-existing cardiac insufficiency. |
| Assessment of quality of life. | From the start of procedure to the end of follow-up at 6 months | 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. |
Countries
China
Contacts
CONTACTLongfu Jiang, MD
Outcome results
None listed