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New pacemaker technique aims to protect heart function

NCT ID NCT07464041

Disease control Sponsor: Samsung Medical Center 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jul 29, 2026 · Updated 3 times

Summary

This study compares a newer pacemaker method, left bundle branch area pacing (LBBAP), to the standard right ventricular pacing in 200 patients with heart block and normal heart function. The goal is to see if LBBAP better preserves the heart's pumping ability and reduces complications like heart failure. Participants will be randomly assigned to one of the two pacing methods and followed over time.

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 (a type of pacemaker lead placement)
What this could lead to
If successful, this could show that a newer pacing method preserves heart function better than the standard approach, potentially reducing the risk of heart failure.
What could go wrong
This is a relatively early comparison study with 200 participants, and the benefits may not be large or apply to all patients. There is also a risk of lead dislodgement or other complications with the new pacing method.

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

200 people

The number who actually took part.

Started

Apr 2024

Expected to finish

Aug 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: Patients requiring permanent pacemaker implantation for the following indications: * Third-degree AV block * First- or second-degree AV block with an expected ventricular pacing burden ≥40% * Atrial fibrillation with slow ventricular response with an expected ventricular pacing burden ≥40% Exclusion Criteria: * Prior implantation of a cardiac pacemaker or implantable cardioverter-defibrillator * Left ventricular ejection fraction ≤50% * Indication for cardiac resynchronization therapy * Life expectancy ≤1 year (e.g., patients not eligible for heart transplantation due to end-stage heart failure, patients with DNR orders, those receiving hospice care after refusal of life-sustaining treatment, or patients with terminal cancer not eligible for chemotherapy or radiotherapy)

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Conditions

The condition(s) this trial relates to.

atrioventricular block conduction system disorder

As listed by the trial registrant

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

Atrioventricular block Conduction system pacing Left bunde branch area pacing

Contacts and locations

Locations

  • Samsung Changwon Hospital

    Changwon, South Korea

  • Samsung Medical Center

    Seoul, Seoul, 06351, South Korea

  • Veterans Health Service Medical Center

    Seoul, South Korea

  • Wonju Severance Christian Hospital

    Wŏnju, Gangwon-do, South Korea

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