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Not yet recruitingNCT07378124Updated Feb 3, 2026

LLL vs. SDL for LBBP: A Non-inferiority RCT

An interventional study of SDL implantation and LLL implantation in Bradycardia and Conduction Block, Atrioventricular, sponsored by Ningbo No.2 Hospital. Not yet recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2026-02-03.

Sponsored by Ningbo No.2 Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
288
Allocation
Randomized
Sex
All
01

Study 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.

02

Conditions studied

  • Bradycardia
  • Conduction Block, Atrioventricular
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts 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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
288 participants (estimated)

Study arms

  • Experimental
    SDL group

    Subjects will receive implantation of a stylet-driven active fixation ventricular lead during the Left Bundle Branch Pacing (LBBP) procedure.

    Procedure: SDL implantation

  • Active comparator
    LLL group

    Subjects will receive implantation of a lumenless active fixaion ventricular lead during the Left Bundle Branch Pacing (LBBP) procedure.

    Procedure: LLL implantation

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.

05

What researchers measure

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 procedure

  2. 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

Secondary 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 months

  3. 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

  4. 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

06

Study locations

1 site
  • Ningbo No.2 Hospital
    Ningbo, Zhejiang 315000, China
07

References and documents

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. PubMed 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. PubMed 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. PubMed 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. PubMed 41180340 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT07378124
Lead sponsor
Ningbo No.2 Hospital
Responsible party
Sponsor
First posted
Jan 30, 2026
Start date
Jan 24, 2026 (estimated)
Primary completion
Jun 30, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Feb 3, 2026

Study contacts

Longfu Jiang, MD
Contact
longfujianghwamei@163.com
0086-574-83871072

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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