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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MEMO Patch PLUS ECG monitoring for One-day | Experimental |
| |
| MEMO Patch PLUS ECG monitoring for More than 8-days | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MEMO Patch PLUS for 1 day | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 2 month(±Month 2) |
| Measure | Description | Time Frame |
|---|---|---|
| Time to the first occurrence of atrial fibrillation/flutter lasting more than 30 seconds after MEMO Patch PLUS is attached. | 1month(+1month), 12 month(±Month 2) | |
| Adaptation rate of anticoagulant or antiplatelet therapy when atrial fibrillation/flutter is diagnosed. |
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[Inclusion criteria]
A participant will be eligible for inclusion in the study if the participant:
[Exclusion criteria]
The participant must be excluded from the study if the participant:
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| Name | Affiliation | Role |
|---|---|---|
| Boyoung Joung | Severance Cardiovascular Hospital Yonsei University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yonsei University Health System, Severance Hospital | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41548032 | Derived | Park SH, Jin JH, Kim J, Lee D, Kim D, Jang J, Yu HT, You SC, Joung B. Wearable device derived electrocardiographic age and its association with atrial fibrillation. NPJ Digit Med. 2026 Jan 17;9(1):157. doi: 10.1038/s41746-026-02344-8. |
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Parallel Assignment
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| MEMO Patch PLUS for More than 8-days | Device | 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. |
|
| 1month(+1month), 12 month(±Month 2) |
| Time required to use or switch to anticoagulant or antiplatelet therapy after atrial fibrillation/flutter diagnosis. | 1month(+1month), 12 month(±Month 2) |
| Burden of total atrial fibrillation/flutter occurrence time | 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. | 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. | 1month(+1month), 12 month(±Month 2) |
| Distribution rate of wearing period of ECG monitoring group for more than 8 days. | 1month(+1month), 12 month(±Month 2) |
| Detection rate of other arrhythmias* except atrial fibrillation/flutter. | 1month(+1month), 12 month(±Month 2) |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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