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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
288
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.
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.
Ningbo No.2 Hospital
Ningbo, Zhejiang, China
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 procedure
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 months
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.
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 months
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 months
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 months
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