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NCT Number: NCT06036342

Atrial Fibrillation Screening With MobiCARE in Subjects With Health Care Examination

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Hospital

Seoul, Jongno-gu, 03080, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects aged 65 years or older who have at least one stroke risk factor*
  • Subjects aged 19 years to <65 years who have two or more stroke risk factors.
  • 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

  • Subjects diagnosed with atrial fibrillation in the past
  • Subjects aged under 19 years and other vulnerable research subjects
  • Subjects who have patch-type adhesive allergies/atopy dermatitis/ urticaria/skin rash/hives that are difficult to apply patches continuously
  • Subjects who have a structural abnormality in the thorax and is difficult to attach the device.
  • Subjects who have cardiac implantable electronic device (pacemaker, implantable cardioverter-defibrillator, implantable loop recorder, or cardiac resynchronized therapy-pacemaker or defibrillator)
  • Subjects requiring immediate ECG analysis or ECG monitoring through hospitalization due to arrhythmia that can be life-threatening
  • Subjects who are deemed inappropriate to participate in the research as judged by the researcher for other reasons.

Treatment and study plan

MobiCARE test

Diagnostic Test

7-days continuous electrocardiography monitoring using MobiCARE device

Primary outcomes

  1. Atrial fibrillation detection rate

    Time frame: 1 year

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

Secondary outcomes

  1. The detection rate of atrial fibrillation

    Time frame: up to 7 days

    The detection rate of atrial fibrillation

  2. The burden of atrial fibrillation.

    Time frame: up to 7 days

    The burden of atrial fibrillation.

  3. The detection rate of other arrhythmias

    Time frame: up to 7 days

    The detection rate of other arrhythmias in addition to atrial fibrillation

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

    Time frame: 1 year

    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

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

    Time frame: 1 year

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

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

    Time frame: up to 1 month

    Questionnaire about convenience of wearing and using the Mobicare device

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

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Daewoong Pharmaceutical Co. LTD.

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2026
First posted
Sep 13, 2023
Registry last updated
May 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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