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New pacemaker technique could improve outcomes for heart rhythm patients

NCT ID NCT07314008

Disease control Sponsor: Asan Medical Center 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares two pacemaker strategies for people with sick sinus syndrome and AV conduction delay. Participants will be randomly assigned to receive either left bundle branch area pacing (LBBAP) or minimized ventricular pacing (MVP). The goal is to see which method leads to fewer deaths, heart failure hospitalizations, or persistent atrial fibrillation. About 440 adults will take part across multiple centers.

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) device
What this could lead to
If successful, this could show that LBBAP is a better pacing method for people with certain heart rhythm problems, potentially reducing complications like heart failure or atrial fibrillation.
What could go wrong
This is an early-stage comparison study, not a large-scale trial. The benefits may not be significant, and device implantation carries risks like 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 440 people

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

Started

May 2025

Expected to finish

Jan 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

18 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: * \>18 years old * Sinus node dysfunction with symptoms * Atrioventricular conduction delay (PR interval \> 200ms) Exclusion Criteria: * Subject was unable to provide written informed consent or participate in long-term follow-up. * Permanent atrial fibrillation * Pre-existing cardiac implantable electronic device * Persistent advanced atrioventricular conduction disturbance (2:1 block, Mobitz type II, or 3rd degree) * Mechanical tricuspid valve * Ventricular septal defect or scar * Left ventricular ejection fraction \< 35% who indicated cardiac resynchronization therapy * Previous heart transplantation * Pregnant and/or lactating women * Life expectancy \<2 year * Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period

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Conditions

The condition(s) this trial relates to.

atrioventricular block atrioventricular node disorder sick sinus syndrome

As listed by the trial registrant

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

Atrioventricular nodal dysfunction Sick sinus syndrome

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

  • Asan Medical Center

    RECRUITING

    Seoul, Songpa-gu, 05505, South Korea

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