Status:
ACTIVE_NOT_RECRUITING
Atrial Fibrillation Screening With MobiCARE in Subjects With Health Care Examination
Lead Sponsor:
Seoul National University Hospital
Collaborating Sponsors:
Daewoong Pharmaceutical Co. LTD.
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
19+ years
Brief 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 und...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 25 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2026
Estimated Enrollment :
3000 Patients enrolled
Trial Details
Trial ID
NCT06036342
Start Date
April 25 2022
End Date
December 31 2026
Last Update
May 18 2025
Active Locations (1)
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1
Seoul National University Hospital
Seoul, Jongno-gu, South Korea, 03080