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A wearable patch could unmask silent heart rhythm that raises stroke risk

NCT ID NCT06036342

Diagnosis Sponsor: Seoul National University Hospital Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests whether a wearable device called MobiCARE, worn for 7 days, can spot undiagnosed atrial fibrillation—an irregular heartbeat that raises stroke risk—in people who have had a routine health check-up. The study enrolls adults with stroke risk factors, such as high blood pressure or diabetes, and aims to see if this screening approach detects more cases than usual care. If successful, it could enable earlier treatment to prevent strokes and improve long-term health.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
MobiCARE, a wearable device that records the heart's electrical activity continuously for 7 days
What this could lead to
If it works, this could lead to a simple, non-invasive way to catch silent atrial fibrillation early and start stroke-prevention treatment sooner.
What could go wrong
The trial is a screening study, so it may not prove that early detection actually prevents strokes. The device might also miss some cases or cause skin irritation.

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.

Participants

3,000 people

The number who actually took part.

Started

Apr 2022

Finished

Dec 2024

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.

Who is studied

Those who have undergone a health screening examination.

Ages

19 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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. Subjects aged 65 years or older who have at least one stroke risk factor\* 2. Subjects aged 19 years to \<65 years who have two or more stroke risk factors. 3. Subjects aged 75 years or older * Stroke risk factors: heart failure, hypertension, diabetes, vascular disease, women, stroke/systemic embolism/transient ischemic attack (although stroke/systemic embolism/transient ischemic attack among stroke risk factors is considered to have two risk factors) * Heart failure: a history of heart failure diagnosis or a history of current heart failure treatment. * Hypertension, Diabetes: Diagnostic History * Vascular diseases: Significant coronal atherosclerosis (when 70% or more of the computed tomography or coronary angiography is present or coronary intervention is performed), 50% or more of the carotid artery disease, peripheral vascular disease, history of myocardial infarction, and aortic plaques Exclusion Criteria: 1. Subjects diagnosed with atrial fibrillation in the past 2. Subjects aged under 19 years and other vulnerable research subjects 3. Subjects who have patch-type adhesive allergies/atopy dermatitis/ urticaria/skin rash/hives that are difficult to apply patches continuously 4. Subjects who have a structural abnormality in the thorax and is difficult to attach the device. 5. Subjects who have cardiac implantable electronic device (pacemaker, implantable cardioverter-defibrillator, implantable loop recorder, or cardiac resynchronized therapy-pacemaker or defibrillator) 6. Subjects requiring immediate ECG analysis or ECG monitoring through hospitalization due to arrhythmia that can be life-threatening 7. Subjects who are deemed inappropriate to participate in the research as judged by the researcher for other reasons.

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Conditions

The condition(s) this trial relates to.

atrial fibrillation stroke disorder prevention target

As listed by the trial registrant

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

Atrial fibrillation

Contacts and locations

Locations

  • Seoul National University Hospital

    Seoul, Jongno-gu, 03080, South Korea

More trials for these conditions

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