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New wearable device could uncover hidden stroke cause

NCT ID NCT05431972

Diagnosis 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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tested a wearable heart monitor called Cardea SOLO against a standard 12-lead EKG to see if it could better detect paroxysmal atrial fibrillation (a temporary irregular heartbeat) in people who had a stroke of unknown cause and have an enlarged heart. 257 participants wore the device or had standard EKGs. The goal was to see if the device catches more cases of atrial fibrillation lasting over 30 seconds, which could help guide treatment to prevent another stroke.

What this could mean

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

Active substance
Cardea SOLO (a wearable heart monitor device)
What this could lead to
If successful, this device could help doctors find hidden atrial fibrillation in stroke survivors more easily, potentially preventing future strokes.
What could go wrong
This is a completed study with 257 participants, but the device may not detect all cases of atrial fibrillation, and results may not apply to all stroke 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

257 people

The number who actually took part.

Started

Nov 2022

Finished

Sep 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.

Ages

19 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: Inclusion NO. 3 or 4 must be satisfied, and No. 2, 5 and 6 must be satisfied. 2\. On the Screening date, Stroke onset date is not over 60 days. 3\. ESUS Diagnosis : all of a\~e must be satisfied. * a. Ischemic stroke detected by CT or MRI that is not lacunar * b. A person without arteriosclerosis which causes at least 50% stenosis of the intracranial/external arteries supplied to the ischemic site * c. During continuous monitoring or halter monitoring In the stroke intensive care unit, Person without atrial fibrillation and persistent atrial fibrillation * d. When checked the Transthoracic echocardiography, No major risk cardioembolic source of embolism. (ex. Myocardial infarction within 4 weeks, mitral stenosis, artificial heart valve and so on) * e. NO other specific cause of stroke identified(et, arteritis, dissection and drug abuse) 4\. cardioembolism is classified by TOAST classification. 5\. Left ventricle Enlargement(male \>40mm, female \>38mm, LAVI \>35ml/m2 6\. Voluntarily sign the consent form Exclusion Criteria: 1. Transient cerebral ischemic attack 2. Active cancer 3. Heart embolism, stroke of major heart embolism, stroke high-risk disease 4. Left atrial thrombus 5. Left ventricular thrombus 6. Sick sinus syndrome 7. Myocardiac infarction in 1 month 8. Rheumatic left atrioventricular valve or aortic valve disease 9. Artificial heart valve 10. Myocardiac infarction (EF\<28%) 11. Congestive heart failure (EF\<30%) 12. Dilated cardiomyopathy 13. Nonbacterial thrombotic endocarditis 14. Endocarditis 15. Intracardiac mass 16. Atrial fibrillation 17. Restriction for echocardiography (obesity, lung disease etc) 18. High risk PFO 19. Patch apply difficulty(skin allergy, ulticaria, atopic dermatitis, hyperhidrosis) 20. Implant cardiac pacemaker 21. Life-threatening arrhythmia 22. Radiation therapy or MRI scan 23. Restriction for Cardia SOLO attachment 24. The person who investigator judged unsuitable for the trial

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Conditions

The condition(s) this trial relates to.

atrial fibrillation intracranial embolism stroke disorder

As listed by the trial registrant

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

Embolic stroke of undetermined source

Contacts and locations

Locations

  • BumJoon Kim

    Seoul, South Korea

More trials for these conditions

Other studies related to the condition(s) this trial covers.