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Can early rhythm control stop hidden heart rhythms from becoming dangerous?

NCT ID NCT07649109

Disease control Sponsor: National Taiwan 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at people with heart devices that detect short bursts of irregular heartbeats (atrial high-rate episodes lasting 6 minutes to 24 hours) but no diagnosed atrial fibrillation. It tests whether starting rhythm-control drugs early, along with managing heart risk factors, can prevent these episodes from turning into sustained atrial fibrillation or clinical atrial fibrillation. Participants are randomly assigned to either early rhythm control or usual care, and researchers track progression, stroke, heart failure, and death 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
Antiarrhythmic drugs and comprehensive cardiovascular risk factor management
What this could lead to
If successful, this approach could reduce the risk of developing sustained atrial fibrillation and related complications like stroke or heart failure.
What could go wrong
This is a Phase 4 study, but the optimal strategy for these short episodes is still uncertain. The intervention may not prevent progression and carries risks from antiarrhythmic drugs.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 450 people

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

Started

Oct 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

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 Age ≥18 years. Presence of a cardiac implantable electronic device (CIED), including permanent pacemaker, implantable cardioverter-defibrillator (ICD), or cardiac resynchronization therapy (CRT) device. Device-detected atrial high-rate episodes (AHREs) lasting ≥6 minutes and \<24 hours. Ability to provide written informed consent. Willingness and ability to comply with study procedures and follow-up visits. Exclusion Criteria Prior diagnosis of clinical atrial fibrillation, atrial flutter, or atrial tachycardia requiring treatment. Device-detected AHRE ≥24 hours before enrollment. Current treatment with class I or class III antiarrhythmic drugs for atrial arrhythmias. Previous catheter ablation for atrial fibrillation or atrial flutter. Planned catheter ablation within the next 3 months. Contraindication to rhythm-control therapy as determined by the treating physician. Life expectancy less than 1 year. Severe comorbid illness that may interfere with study participation or follow-up. Pregnancy or breastfeeding. Participation in another interventional clinical trial that may affect study outcomes.

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Conditions

The condition(s) this trial relates to.

Arrhythmias, Cardiac atrial fibrillation cardiac rhythm disease

As listed by the trial registrant

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

Cardiac arrhythmias Subclinical atrial fibrillation

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

  • National Taiwan University Hospital

    RECRUITING

    Taipei, Taiwan

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