A Clinical Trial to Evaluate the Detection of Atrial Fibrillation for an One Day Versus More Than or Equal to Eight Days Using MEMO Patch PLUS in Individuals Aged ≥ 75 Years, or Those at High Risk of Stroke

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
A Prospective, Multi-Center, Randomized Clinical Trial to Evaluate the Detection of Atrial Fibrillation for an One Day Versus More Than or Equal to Eight Days Using MEMO Patch PLUS in Individuals Aged ≥ 75 Years, or Those at High Risk of Stroke: MEMO-DAF8

Conditions
-----------------
Atrial Fibrillation/Flutter in Patients With High Risk of Stroke

Intervention / Treatment
-----------------
* Device: MEMO Patch PLUS for 1 day
* Device: MEMO Patch PLUS for More than 8-days


Participation Criteria
=================
Eligibility Criteria
-----------------
[Inclusion criteria] A participant will be eligible for inclusion in the study if the participant: Has provided documented informed consent for the study. Is adult at least 19 years of age on the day of providing documented informed consent Is the high risk group for stroke, i.e. adult at least 75 years of age or CHA2DS2-VASc score more than 2 Is life expectancy more than 6 months Has no Atrial fibrillation or Atrial flutter as a result of 12-lead ECG Has symptoms associated with Atrial fibrillation *symptoms associated with Atrial fibrillation: palpitation, dizziness, dyspnea, syncope, stroke/transient ischemic accident, systemic embolism etc. [Exclusion criteria] The participant must be excluded from the study if the participant: Has had prior history of Atrial fibrillation or Atrial flutter Has received prior or ongoing anticoagulant or antiplatelet therapy Has inserted Pacemaker or Defibrillator that can diagnose Atrial fibrillation or Atrial flutter Has plan of Carotid endarterectomy or inserting Stent* within 90 days on the day of providing document informed consent *Stent insertion: means when stent-related interventions have been performed on the carotid arteyr or coronary arteries.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MEMO Patch PLUS ECG monitoring for One-day<br> | Device: MEMO Patch PLUS for 1 day<br>* 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.<br>|
| Experimental: MEMO Patch PLUS ECG monitoring for More than 8-days<br> | Device: MEMO Patch PLUS for More than 8-days<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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. |  | 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) |