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CompletedNCT06036342Updated Aug 20, 2026

Atrial Fibrillation Screening With MobiCARE in Subjects With Health Care Examination

An observational study in Atrial Fibrillation, sponsored by Seoul National University Hospital. Completed at 1 site in South Korea. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-20.

Sponsored by Seoul National University Hospital · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
3,000
Ages
19 Years and older
Sex
All
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Study summary

This study aimed to detect and diagnose atrial fibrillation early by conducting a screening test for atrial fibrillation using a continuous electrocardiography monitoring device for those who have undergone a health screening examination.

Early detection through atrial fibrillation screening tests in high-risk patients with stroke is intended to prevent stroke by starting stroke prevention treatment early. It is intended to detect asymptomatic atrial fibrillation patients early through examination and ultimately improve the quality of life.

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Conditions studied

  • Atrial Fibrillation

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03

In context

Atrial Fibrillation

3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.

This study's enrollment of 3,000 is above the median of 300 across 1,363 observational studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Those who have undergone a health screening examination.

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

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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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
3,000 participants (actual)
Patient registry
No

Interventions

  • Diagnostic testMobiCARE test

    7-days continuous electrocardiography monitoring using MobiCARE device

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What researchers measure

Primary outcomes

  1. Atrial fibrillation detection rate

    Atrial fibrillation detection rate at 1-year follow-up time

    Time frame: 1 year

Secondary outcomes

  1. The detection rate of atrial fibrillation

    The detection rate of atrial fibrillation

    Time frame: up to 7 days

  2. The burden of atrial fibrillation.

    The burden of atrial fibrillation.

    Time frame: up to 7 days

  3. The detection rate of other arrhythmias

    The detection rate of other arrhythmias in addition to atrial fibrillation

    Time frame: up to 7 days

  4. The rate of initiation of antiarrhythmic and anticoagulant therapy, and the rate of receiving treatment related to rhythm control

    The rate of initiation of antiarrhythmic and anticoagulant therapy, and the rate of receiving treatment related to rhythm control at 1-year follow-up time

    Time frame: 1 year

  5. Clinical outcome during 1-year follow-up.

    stroke, transient ischemic attack, systemic embolism, admission for heart failure, admission for atrial fibrillation manage/control, cardiac arrest, cardiovascular death, and all-cause death

    Time frame: 1 year

  6. Evaluation of the convenience of wearing and using the Mobicare device

    Questionnaire about convenience of wearing and using the Mobicare device 1. Did you feel uncomfortable going about your daily routine, and mainly when? 2. If you felt uncomfortable, what were your main concerns? 3. If your skin itches or breaks out in a rash during use, how long has it been since you've been wearing it? 4. How much discomfort did you experience due to foreign body sensation, skin problems, etc.? 5. Has your device ever been dropped while in use? If so, when did it happen? 6. Were there any challenges in reattaching the device, and if so, what were they? 7. How often have you taken your device off and put it back on? 8. How long do you think you can run the test without too much inconvenience?

    Time frame: up to 1 month

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Study locations

1 site
  • Seoul National University Hospital
    Seoul, Jongno-gu 03080, South Korea
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06036342
Lead sponsor
Seoul National University Hospital
Collaborators
Daewoong Pharmaceutical Co. LTD.
Responsible party
Eue-Keun Choi (Professor, Seoul National University Hospital) — Principal investigator
First posted
Sep 13, 2023
Start date
Apr 25, 2022
Primary completion
Dec 10, 2024
Completion
Dec 10, 2024
Last update
Aug 20, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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