Can early action tame hidden heart flutters?
NCT ID NCT07447297
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether starting treatment early for atrial fibrillation (AF) that is only detected by heart devices can help control the condition. About 520 adults with these hidden AF episodes will be randomly assigned to either early rhythm control therapy (medication, shock, or a procedure) or standard care without rhythm control. The goal is to see if early treatment reduces AF burden by half or prevents it from becoming a clinical problem.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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About 520 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2024
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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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
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19 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * Among patients with Cardiac implantable electronic device (CIED), subjects with atrial high rate episodes found Cardiac implantable electronic devices: implantable loop recorder, pacemaker, implantable cardioverter defibrillator(ICD), cardiac resynchronized therapy(CRT) * Patients aged 19 or older who have agreed to the study (if voluntary consent is deemed difficult, consent from legal representatives is obtained together) * If the accumulated period of the atrial high rate episode during the three-month observation period is more than 21 hours * Patients whose atrial fibrillation has not been confirmed by electrocardiogram or holter monitoring within the past year from the time atrial high rate episode was detected However, enrollment is possible even if it includes one of the following two cases ⓐ Patients diagnosed and recorded as atrial fibrillation on medical records but not confirmed by electrocardiogram or holter monitoring ⓑ If there is a record of atrial fibrillation, but Paroxysmal AF less than 30 seconds Exclusion Criteria: * Patients deemed inappropriate to participate in the study by the investigator * Patients diagnosed with atrial fibrillation with 12-lead electrocardiogram or holter within the past year prior to participation in the study * Patients taking Class Ic, III of antiarrhythmic drugs prior to study participation * Patients who have had rhythm control treatments such as Radiofequency catheter ablation (RFCA), Total thoracoscopic ablation (TTA), Maze procedure (MAZEop), and antiarrhythmic treatment due to atrial fibrillation (except for CTI ablation with AFL) * Patients whose life expectancy is less than one year (e.g., patients who can't even have a heart transplant, patients who receive DNR, Patients in hospice wards who refuse life-sustaining treatment, terminal cancer patients who cannot receive radiation or chemotherapy, etc.)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Samsung Medical Center
RECRUITINGSeoul, Seoul, 06351, South Korea
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