LLL vs. SDL for LBBP: A Non-inferiority RCT
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SDL implantation, LLL implantation.
- Who it may be relevant to
- Registry conditions: Bradycardia, Conduction Block, Atrioventricular. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy and Safety Comparison of Lumenless Lead Versus Stylet-driven Lead in Intraoperative Application of Left Bundle Branch Pacing Guided by Continuous Pacing Monitoring With S-V Dissociation as the Primary Outcome: A Non-inferiority, Multicenter, Prospective Randomized Controlled Trial
Overview
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
- Procedure SDL 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. - Procedure LLL 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.
Primary outcome measures
- The primary efficacy endpoint [Time frame: During the LBBP procedure]
- The primary safety endpoint [Time frame: From start of the procedure to the end of follow-up at 6 months]
Secondary outcome measures (4)
- Procedural success rate [Time frame: During the procedure.]
- Abnormal parameters detected during follow-up [Time frame: From the start of procedure to the end of follow-up at 6 months]
- Assessment of cardiac function during follow-up [Time frame: From the start of procedure to the end of follow-up at 6 months]
- Assessment of quality of life. [Time frame: From the start of procedure to the end of follow-up at 6 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Ningbo No.2 Hospital — Ningbo
Publications
- 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. PMID 36113707
- 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. PMID 39515497
- 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. PMID 40831032
- 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. PMID 41180340
Identifiers
NCT: NCT07378124 · PJ-NBEY-KY-2026-014-01