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Can a novel pacemaker strategy tame stubborn atrial fibrillation?

NCT ID NCT06699342

Disease control Sponsor: Seoul National University Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 20, 2026 · Last updated Aug 21, 2026 · Updated 1 time

Summary

This trial is investigating whether a combination of left bundle branch area pacing (a new way to pace the heart) and atrioventricular node ablation (a procedure to disrupt faulty electrical signals) can improve outcomes for people with symptomatic atrial fibrillation who haven't responded to drugs or catheter ablation. The study will enroll 50 adults aged 65 and older with permanent atrial fibrillation and reduced heart function. Researchers will compare this approach to guideline-based drug therapy, measuring changes in heart strain (NT-proBNP) and quality of life over up to 24 months.

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) combined with atrioventricular node ablation
What this could lead to
If successful, this approach could offer a more effective treatment option for people with atrial fibrillation who haven't been helped by medications or standard procedures, potentially improving heart function and quality of life.
What could go wrong
This is a relatively small trial, and the procedure carries risks such as bleeding, infection, or heart rhythm complications. The benefits may not be greater than standard drug therapy, and results may not apply to all patients.

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 50 people

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

Started

Jan 2025

Expected to finish

Dec 2027

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

65 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: Patients who meet all of the following inclusion criteria 1)-6). 1. Permanent atrial fibrillation 2. Age ≥ 65 years 3. Refractory or intolerant to antiarrhythmic drugs, rate control medications, or catheter ablation 4. New York Heart Association (NYHA) functional class II- IV 5. LVEF \> 40% (within the past 3 months) 6. Patients with at least one of the following: 1. HF hospitalization (defined as HF as the major reason for hospitalization or treatment for HF lasting ≥12 hours and including treatment with intravenous (IV) diuretics at a healthcare facility) within 12 months 2. Elevated NT-proBNP (\>900 pg/ml) in the 30 days prior to enrollment Exclusion: Patients who meet at least one of the following exclusion criteria 1)-11). 1. Asymptomatic atrial fibrillation 2. Life expectancy to \< 12 months. 3. Primary moderate to severe valvular disease (except for functional mitral valve regurgitation or tricuspid valve regurgitation) 4. Mechanical tricuspid valve replacement 5. Severe chronic kidney disease (estimated Glomerular Filtration Rate ≤ 15 ml/1,73 m2 or receiving renal replacement treatment including hemodialysis or peritoneal dialysis) 6. Obstructive hypertrophic cardiomyopathy 7. Infiltrative cardiomyopathy (amyloidosis, sarcoidosis, Fabry disease, others) 8. Acute coronary syndrome or coronary revascularization (CABG or PCI) \<3 months 9. Severe primary pulmonary disease such as cor pulmonale, irreversible lung disease requiring inhalers, oxygen supplementation 10. Pacemaker/ICD/CRT treatment ongoing, or current pacemaker indication 11. Simultaneous participation in a different randomized clinical trial

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Conditions

The condition(s) this trial relates to.

atrial fibrillation

As listed by the trial registrant

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

Atrial fibrillation (AF)

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

  • Seoul National University Hospital

    RECRUITING

    Seoul, Jongno-gu, 03080, South Korea

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