Atrial FibrillationNCT06036342
Atrial Fibrillation Screening With MobiCARE in Subjects With Health Care Examination
An observational study of Atrial Fibrillation, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- MobiCARE test
- How many people
- 3,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 25 Apr 2022to 10 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Those who have undergone a health screening examination.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Hospital
Seoul, Jongno-gu, 03080
About this study
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.
- Conditions
- Atrial Fibrillation
- Being tested
- MobiCARE test
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MobiCARE testDiagnostic test
7-days continuous electrocardiography monitoring using MobiCARE device
What is being measured
The primary outcome is the main question the study is designed to answer.
Atrial fibrillation detection rate
Atrial fibrillation detection rate at 1-year follow-up time
Measured: 1 year
Secondary outcomes (6)
The detection rate of atrial fibrillation
The detection rate of atrial fibrillation
Measured: up to 7 days
The burden of atrial fibrillation.
The burden of atrial fibrillation.
Measured: up to 7 days
The detection rate of other arrhythmias
The detection rate of other arrhythmias in addition to atrial fibrillation
Measured: 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
Measured: 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
Measured: 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?
Measured: up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start25 Apr 2022
- Primary completion10 Dec 2024
- Study completion10 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Daewoong Pharmaceutical Co. LTD.
- Responsible party
- Principal investigator, Eue-Keun Choi, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06036342
- Sponsor's protocol ID
- AF-CARE
- Status last verified
- Aug 2026
- First submitted
- 20 Mar 2023
- Last updated
- 20 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atrial Fibrillation Screening With MobiCARE in Subjects With Health Care Examination
- ClinicalTrials.gov ID
- NCT06036342
- Acronym / sponsor ID
- AF-CARE
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,000 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Daewoong Pharmaceutical Co. LTD.
- Study start
- 25 Apr 2022 (actual)
- Primary completion
- 10 Dec 2024 (actual)
- Study completion
- 10 Dec 2024 (actual)
- First posted
- 13 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Those who have undergone a health screening examination.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MobiCARE test7-days continuous electrocardiography monitoring using MobiCARE device | Diagnostic test | – |
Primary outcome
Atrial fibrillation detection rate
Time frame: 1 year
Atrial fibrillation detection rate at 1-year follow-up time
6 secondary outcomes
The detection rate of atrial fibrillation
Time frame: up to 7 days
The burden of atrial fibrillation.
Time frame: up to 7 days
The detection rate of other arrhythmias
Time frame: up to 7 days
The rate of initiation of antiarrhythmic and anticoagulant therapy, and the rate of receiving treatment related to rhythm control
Time frame: 1 year
Clinical outcome during 1-year follow-up.
Time frame: 1 year
Evaluation of the convenience of wearing and using the Mobicare device
Time frame: up to 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Atrial fibrillation detection rate (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.