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New pacing technique may lower heart failure risk in pacemaker patients

NCT ID NCT05585411

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests if a newer pacing method, left bundle branch area pacing, is better than standard right ventricular pacing for people who need a pacemaker. Researchers will compare outcomes like death, heart failure, and heart damage in 450 participants over two years. The goal is to see if the newer method can prevent complications from long-term pacing.

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 procedure to place a pacemaker lead in a specific heart area)
What this could lead to
If successful, this could show that a newer pacing method reduces the risk of heart failure and death compared to standard pacing.
What could go wrong
This is an early-stage comparison study with 450 participants, so results may not apply to all patients. The procedure itself carries standard risks of pacemaker implantation, such as infection or lead displacement.

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 450 people

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

Started

Nov 2022

Expected to finish

Nov 2026

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. At least 19 years old and willing and capable to give informed consent 2. Patients who is willing and able to comply with the prescribed follow-up tests and schedule of evaluations. 3 Scheduled to receive a pacemaker implant 4. Substantial percentage of V pacing rate (\>40%) is anticipated Exclusion criteria: 1. Incapacitated or unable to read or write 2. Patient who is an indication of ICD or CRT 3. History of prosthetic valve surgery on tricuspid valve 4. Prior myocardial infarction including ventricular septum 5. Life expectancy \< 12 months due to any condition 6. Unavailable for at least 24 months of follow-up visits 7. Pregnant or breastfeeding at the time of signing consent 8. Prior Heart transplant surgery 9. Persistent Left Superior Vena Cava (PLSVC)

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Conditions

The condition(s) this trial relates to.

atrioventricular block Bradycardia heart failure

As listed by the trial registrant

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

Atrioventricular block Bradyarrhythmia Left bundle branch area pacing

How to take part

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

  1. The places running it

    8 sites. 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

  • Asan Medical Center

    RECRUITING

    Seoul, South Korea

  • Bucheon Sejong Hospital

    RECRUITING

    Bucheon-si, South Korea

  • Chungbuk National University Hospital

    RECRUITING

    Chungju, South Korea

  • GyeongSang National University Changwon Hospital

    RECRUITING

    Changwon, South Korea

  • Kyunghee University hospital

    RECRUITING

    Seoul, South Korea

  • Seoul National University Hospital

    RECRUITING

    Seoul, South Korea

  • Seoul Saint Mary's Hospital

    RECRUITING

    Seoul, South Korea

  • Yonsei University Health System, Severance Hospital

    NOT_YET_RECRUITING

    Seoul, South Korea

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