BradycardiaNCT07378124
LLL vs. SDL for LBBP: A Non-inferiority RCT
A study testing SDL implantation and LLL implantation in people with Bradycardia and Conduction Block, Atrioventricular, run by Ningbo No.2 Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bradycardia, Conduction Block, Atrioventricular
- What is being tested?
- SDL implantation and LLL implantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 288 participants
- Where
- 1 siteChina
- Study dates
- 24 Jan 2026to 31 Dec 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Ningbo No.2 Hospital
Ningbo, Zhejiang, 315000
Xianfeng Du, MD, 0086-574-83871073, drduxianfeng@126.com
About this study
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
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.
- Conditions
- Bradycardia, Conduction Block, Atrioventricular
- Being tested
- SDL implantation, LLL implantation
- Medical subject headings
- Bradycardia, Atrioventricular Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SDL implantationProcedure or surgery
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 implantationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| SDL group | Experimental | Subjects will receive implantation of a stylet-driven active fixation ventricular lead during the Left Bundle Branch Pacing (LBBP) procedure. Receives: 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. Receives: Procedure: LLL implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: From start of the procedure to the end of follow-up at 6 months
Secondary outcomes (4)
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.
Measured: During the procedure.
Abnormal parameters detected during follow-up
Clinically significant abnormalities in pacing lead parameters detected during pacemaker programming throughout the follow-up period.
Measured: 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.
Measured: 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.
Measured: From the start of procedure to the end of follow-up at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2026
- Study start24 Jan 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for BradycardiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 288 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ningbo No.2 Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07378124
- Sponsor's protocol ID
- PJ-NBEY-KY-2026-014-01
- Status last verified
- Jan 2026
- First submitted
- 17 Jan 2026
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 36113707Shen 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 39515497Wu 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 40831032Shen 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