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Pacemaker lead position may cut heart rhythm complication

NCT ID NCT06023784

NEW Prevention Sponsor: Peking Union Medical College Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 21, 2026 · Last updated Sep 21, 2026

Summary

Researchers compare two ways of placing a pacemaker lead in people with atrioventricular block, a condition where the heart's electrical signal is blocked. One method, left bundle branch area pacing, aims to mimic the heart's natural activation; the other, right ventricular pacing, is the traditional approach. The trial tracks how many participants develop new-onset atrial fibrillation, along with heart function, hospitalizations, and quality of life. About 530 adults with a slow or blocked heartbeat take part.

What this could mean

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

Active substance
left bundle branch area pacing compared with right ventricular pacing
What this could lead to
If left bundle branch area pacing lowers the rate of new atrial fibrillation, it could become the preferred pacing method for people with atrioventricular block.
What could go wrong
This is a single-center study, so its results may not apply everywhere. Pacemaker procedures carry small risks of infection, bleeding, or lead problems, and the trial may not show a clear difference between the two methods.

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 530 people

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

Started

Sep 2023

Expected to finish

Dec 2030

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

18 to 85 years

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: * Adult patients aged 18-85; * AV block patients with ventricular pacing indications and the expected rate of ventricular pacing(VP)\> 40%, including (a) third-degree AV block; (b) second degree AV block (type II); (c) intermittent advanced AV block with expected VP\>40%; (d) symptomatic first degree AV block and PR interval on ECG \> 300ms; * Signed informed consent; Exclusion Criteria: * Baseline echocardiographic assessment of patients with impaired LV function (LVEF\<50%); * Patients with the history of atrial fibrillation; * Having difficulties in follow-up: Those who cannot accept 2-year follow-up on time due to physical condition or other reasons; * Pacemaker replacement without new implanted ventricular electrodes; * Surgery is required within 1 year due to severe structural heart disease; * Patients with tricuspid mechanical valve replacement, or congenital heart disease (including transposition of the great arteries, or permanent left superior vena cava, etc); * AV block resulting from: (a) Hypertrophic cardiomyopathy(HCM), (b) ventricular septal defect repair, and those who are unlikely to achieve successful LBBAP procedure.

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Conditions

The condition(s) this trial relates to.

atrioventricular block atrial fibrillation prevention target

As listed by the trial registrant

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

Atrial fibrillation Atrioventricular block Left bundle branch area pacing Right ventricular pacing

How to take part

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  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.

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  3. A doctor treating you

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Contacts and locations

Locations

  • Chinese Academy of Medical Sciences & Peking Union Medical College, Peking Union Medical College Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100730, China

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