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New study aims to perfect heart pacing lead placement

NCT ID NCT07378124

Disease control Sponsor: Ningbo No.2 Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This trial tests two different heart pacing leads—one without a hollow core (lumenless) and one with a stylet—to see which works better for left bundle branch pacing. About 288 people with slow heart rhythms will take part. Doctors will use continuous monitoring to guide the lead placement and check for a specific electrical sign (S-V dissociation) to confirm correct positioning. The goal is to improve success rates and reduce risks like heart perforation.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Procedure: implantation of a lumenless lead or a stylet-driven lead for heart pacing
What this could lead to
If successful, this could establish a safer, more effective standard technique for left bundle branch pacing, reducing complications like heart perforation.
What could go wrong
This is an early-stage trial with 288 participants, so results may not apply to all patients. The procedure itself carries risks such as infection or lead dislodgement.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 288 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

atrial fibrillation atrioventricular block Bradycardia sick sinus syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bradycardia Conduction block, atrioventricular

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Ningbo No.2 Hospital

    Ningbo, Zhejiang, 315000, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.