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.

Study Overview

• Status: Active, not recruiting
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Diagnostic test: MobiCARE test

• Study Type: Observational
• Enrollment (Actual): 3000

Contacts and Locations

Study Locations

• Korea, Republic of
  • Jongno-gu
    • Seoul, Jongno-gu, Korea, Republic of, 03080
      • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Those who have undergone a health screening examination.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Atrial fibrillation detection rate	Atrial fibrillation detection rate at 1-year follow-up time	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The detection rate of atrial fibrillation	The detection rate of atrial fibrillation	up to 7 days
The burden of atrial fibrillation.	The burden of atrial fibrillation.	up to 7 days
The detection rate of other arrhythmias	The detection rate of other arrhythmias in addition to atrial fibrillation	up to 7 days
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	1 year
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	1 year
Evaluation of the convenience of wearing and using the Mobicare device	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?	up to 1 month

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: Daewoong Pharmaceutical Co. LTD.

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2022
• Primary Completion (Actual): December 10, 2024
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: March 20, 2023
• First Submitted That Met QC Criteria: September 6, 2023
• First Posted (Actual): September 13, 2023

Study Record Updates

• Last Update Posted (Actual): May 18, 2025
• Last Update Submitted That Met QC Criteria: May 14, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: AF-CARE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No