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NCT Number: NCT07378124

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

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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Key information

Conditions

Bradycardia Arrhythmias, Cardiac Atrioventricular Block Cardiac Conduction System Disease Cardiovascular Diseases Conduction Block, Atrioventricular Heart Block Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. The primary efficacy endpoint

    Time frame: 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.

  2. The primary safety endpoint

    Time frame: 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 outcomes

  1. Procedural success rate

    Time frame: 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.

  2. Abnormal parameters detected during follow-up

    Time frame: 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.

  3. Assessment of cardiac function during follow-up

    Time frame: 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.

  4. Assessment of quality of life.

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Longfu Jiang, MD

CONTACT

[email protected]

0086-574-83871072

Sponsors and collaborators

Lead sponsor

Ningbo No.2 Hospital

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 30, 2026
Registry last updated
Feb 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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