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Which pacing target keeps the heart stronger? a trial aims to find out

NCT ID NCT07804394

Disease control Sponsor: Yonsei University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 04, 2026 · Last updated Sep 04, 2026

Summary

This trial tests two ways of placing a pacemaker lead in the heart's left bundle branch area. One strategy aims to directly capture the heart's conduction system, while the other accepts capture of the nearby septal muscle. Researchers will compare how well the heart's pumping function holds up over 12 months in 300 adults who need a pacemaker for slow heart rhythms. The goal is to see whether the more precise approach is worth the extra effort.

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 (LBBAP) with two procedural endpoints: mandatory direct capture of the left ventricular conduction system versus left ventricular septal capture alone.
What this could lead to
If direct capture proves better, it could refine pacing procedures to preserve heart function and reduce the risk of pacing-induced heart failure.
What could go wrong
The trial is relatively small and early, and the two strategies may end up with similar outcomes. There are also procedural risks like lead dislodgement or complications during implantation.

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 300 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Nov 2029

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

19 years and older

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 1. Patients with a guideline-based indication for permanent pacemaker implantation for bradyarrhythmia and an expected ventricular pacing burden (VP) of 40% or more. 2. Patients in whom a left bundle branch area pacing (LBBAP) procedure is planned in accordance with the above indication. 3. Age 19 years or older. 4. Provision of written informed consent to participate in the study. Exclusion Criteria 1. Inability to understand the study or unwillingness to consent to participation. 2. History of mechanical tricuspid valve replacement. 3. History of myocardial infarction involving the interventricular septum. 4. Life expectancy of 12 months or less. 5. Inability to complete 12 months of follow-up for any reason. 6. Pregnancy. 7. History of cardiac transplantation. 8. Indication for cardiac resynchronization therapy (CRT), defined as LVEF \<=35% and QRS duration \>=130 ms with left bundle branch block and NYHA functional class II to IV. This population is the subject of a separate randomized CRT trial and is distinct from the non-CRT pacemaker population studied here. 9. Presence of an existing permanent pacemaker, implantable cardioverter-defibrillator, or CRT device (procedures performed for device replacement are not eligible).

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Conditions

The condition(s) this trial relates to.

Arrhythmias, Cardiac atrioventricular block Bradycardia cardiomyopathy conduction system disorder progressive familial heart block, type 1A sick sinus syndrome Ventricular Dysfunction

As listed by the trial registrant

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

Artificial Atrioventricular block Bradycardia Bundle-branch block Cardiac pacing Cardiomyopathies Heart conduction system LEFT Sick sinus syndrome Ventricular dysfunction

How to take part

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  1. The official record

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  2. A doctor treating you

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