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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SDL group | Experimental | Subjects will receive implantation of a stylet-driven active fixation ventricular lead during the Left Bundle Branch Pacing (LBBP) procedure. |
|
| LLL group | Active Comparator | Subjects will receive implantation of a lumenless active fixaion ventricular lead during the Left Bundle Branch Pacing (LBBP) procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SDL implantation | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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). | From start of the procedure to the end of follow-up at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | During the procedure. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Longfu Jiang, MD | Contact | 0086-574-83871072 | longfujianghwamei@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ningbo No.2 Hospital | Ningbo | Zhejiang | 315000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36113707 | Result | Shen J, Jiang L, Wu H, Cai X, Zhuo S, Pan L. A Continuous Pacing and Recording Technique for Differentiating Left Bundle Branch Pacing From Left Ventricular Septal Pacing: Electrophysiologic Evidence From an Intrapatient-Controlled Study. Can J Cardiol. 2023 Jan;39(1):1-10. doi: 10.1016/j.cjca.2022.09.008. Epub 2022 Sep 14. | |
| 39515497 |
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| ID | Term |
|---|---|
| D001919 | Bradycardia |
| D054537 | Atrioventricular Block |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| LLL implantation | Procedure | 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. |
|
| Abnormal parameters detected during follow-up | Clinically significant abnormalities in pacing lead parameters detected during pacemaker programming throughout the follow-up period. | 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. | 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. | From the start of procedure to the end of follow-up at 6 months |
| Shen J, Jiang L, Wu H, Zhang L, Li H, Pan L. Electrophysiological characteristics of lead position-dependent electrogram uninterrupted transition during left bundle branch pacing. Heart Rhythm. 2025 May;22(5):1279-1288. doi: 10.1016/j.hrthm.2024.10.062. Epub 2024 Nov 6. |
| 40831032 | Result | Wu H, Jiang L, Chen W, Zhuo S, Shen J, Zhang L, Zhang Y, Peng X. Short- to Mid-Term Efficacy and Safety of Left Bundle Branch Pacing Guided by Continuous Uninterrupted Paced Intracardiac Electrogram Monitoring Targeting Transition to Selective Left Bundle Branch Capture. J Cardiovasc Electrophysiol. 2025 Nov;36(11):2839-2848. doi: 10.1111/jce.70054. Epub 2025 Aug 19. |
| 41180340 | Result | Shen J, Jiang L, Wu H, Li H. Continuous Pacing and Recording Technique: A Real-Time Feedback Approach for Left Bundle Branch Pacing. CJC Open. 2025 Jul 22;7(10):1357-1365. doi: 10.1016/j.cjco.2025.07.008. eCollection 2025 Oct. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D006327 | Heart Block |
| D000075224 | Cardiac Conduction System Disease |