NCT07378124

Brief 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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
288

participants targeted

Target at P75+ for not_applicable

Timeline
18mo left

Started Jan 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress27%
Jan 2026Dec 2027

First Submitted

Initial submission to the registry

January 17, 2026

Completed
7 days until next milestone

Study Start

First participant enrolled

January 24, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 30, 2026

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

February 3, 2026

Status Verified

January 1, 2026

Enrollment Period

1.4 years

First QC Date

January 17, 2026

Last Update Submit

January 31, 2026

Conditions

BradycardiaConduction Block, Atrioventricular

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (4)

  • Procedural success rate

    During the procedure.

  • Abnormal parameters detected during follow-up

    From the start of procedure to the end of follow-up at 6 months

  • Assessment of cardiac function during follow-up

    From the start of procedure to the end of follow-up at 6 months

  • Assessment of quality of life.

    From the start of procedure to the end of follow-up at 6 months

Study Arms (2)

SDL group

EXPERIMENTAL

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

Procedure: SDL implantation

LLL group

ACTIVE COMPARATOR

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

Procedure: LLL implantation

Interventions

SDL implantationPROCEDURE

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.

SDL group
LLL implantationPROCEDURE

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.

LLL group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ningbo No.2 Hospital

Ningbo, Zhejiang, 315000, China

Location

Related Publications (4)

  • 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: 36113707RESULT

  • 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: 39515497RESULT

  • 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: 40831032RESULT

  • 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: 41180340RESULT

MeSH Terms

Conditions

BradycardiaAtrioventricular Block

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsHeart BlockCardiac Conduction System Disease

Central Study Contacts

Longfu Jiang, MD

CONTACT

0086-574-83871072longfujianghwamei@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2026

First Posted

January 30, 2026

Study Start

January 24, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

February 3, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)