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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Atrial Fibrillation/Flutter in Patients With High Risk of Stroke
- Sponsor
- Yonsei University
- Enrollment
- 1000
- Locations
- 1
- Primary Endpoint
- Incidence of newly diagnosed AF
- Status
- Completed
- Last Updated
- 7 months ago
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Incidence of newly diagnosed AF
Time Frame: 2 month(±Month 2)
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.
Secondary Outcomes
- Adaptation rate of anticoagulant or antiplatelet therapy when atrial fibrillation/flutter is diagnosed.(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))
- 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))
- 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))
- Detection rate of other arrhythmias* except atrial fibrillation/flutter.(1month(+1month), 12 month(±Month 2))