The purpose of this study is to evaluate the benefits in the atrial fibrillation detection rate of the continuous ECG monitoring group for more than 8 days by contrasting with one-day ECG monitoring using MEMO Patch PLUS in 1000 patients with atrial fibrillation-related symptoms in the high risk group of stroke. The participant is allocated randomly to One-day ECG monitoring group or the continuous ECG monitoring group for more than 8 days in ratio of 1:1, only if the participant provides informed consent and eligible for all the inclusion/exclusion criteria. The investigator confirms the results of MEMO Patch PLUS monitoring at 1 month from the date of MEMO Patch PLUS attachment. The participation of the subject is terminated on the 1 year from the date of MEMO Patch PLUS attachment. On that day, investigator evaluates incidence of the event associated with atrial fibrillation, the event is included ischemic stroke/transient ischemic accident, hemorrhagic stroke, systemic embolism, etc.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
1,000
Individuals randomized to one-day monitoring will wear MEMO Patch PLUS for 1 day. After that, confirm the monitoring result and carry out a fixed schedule.
Individuals randomized to More than 8-days monitoring will wear MEMO Patch PLUS for 8 days \~ 14 days at their voluntarily. After that, confirm the monitoring result and carry out a fixed schedule.
Yonsei University Health System, Severance Hospital
Seoul, South Korea
Incidence of newly diagnosed AF
Incidence of newly diagnosed AF refers to a case that lasts longer than 30 seconds, which is an indication for anticoagulation or antiplatelet therapy in standard therapy.
Time frame: 1 month(+1month)
Incidence of newly diagnosed AF
Incidence of newly diagnosed AF refers to a case that lasts longer than 30 seconds, which is an indication for anticoagulation or antiplatelet therapy in standard therapy.
Time frame: 2 month(±Month 2)
Time to the first occurrence of atrial fibrillation/flutter lasting more than 30 seconds after MEMO Patch PLUS is attached.
Time frame: 1month(+1month), 12 month(±Month 2)
Adaptation rate of anticoagulant or antiplatelet therapy when atrial fibrillation/flutter is diagnosed.
Time frame: 1month(+1month), 12 month(±Month 2)
Time required to use or switch to anticoagulant or antiplatelet therapy after atrial fibrillation/flutter diagnosis.
Time frame: 1month(+1month), 12 month(±Month 2)
Burden of total atrial fibrillation/flutter occurrence time
Time frame: 1month(+1month), 12 month(±Month 2)
Incidence of significant medical events or death due to ischemic stroke/transient ischemic attack, systemic embolism, hemorrhagic stroke, atrial fibrillation/flutter.
Time frame: 1month(+1month), 12 month(±Month 2)
Percentage of arrhythmias including atrial fibrillation/flutter were detected and surgery/procedure was performed for therapeutic or diagnostic purposes.
Time frame: 1month(+1month), 12 month(±Month 2)
Distribution rate of wearing period of ECG monitoring group for more than 8 days.
Time frame: 1month(+1month), 12 month(±Month 2)
Detection rate of other arrhythmias* except atrial fibrillation/flutter.
Time frame: 1month(+1month), 12 month(±Month 2)
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