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

Not Applicable

• Conditions: Atrial Fibrillation/Flutter in Patients With High Risk of Stroke
• Interventions: Device: MEMO Patch PLUS for More than 8-days; Device: MEMO Patch PLUS for 1 day

• Registration Number: NCT05355948
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-04
• Study First Submitted: 2022-04-21
• Study First Submitted QC: 2022-04-29
• Last Update Submitted: 2022-04-29
• Study Start: 2022-05
• Study First Posted: 2022-05-02
• Last Update Posted: 2022-05-02
• Primary Completion: 2023-07-31
• Study Completion: 2024-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MEMO Patch PLUS ECG monitoring for More than 8-days	MEMO Patch PLUS for More than 8-days	-
MEMO Patch PLUS ECG monitoring for One-day	MEMO Patch PLUS for 1 day	-

Primary Outcome Measures

Name	Time	Method
Incidence of newly diagnosed AF	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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Yonsei University Health System, Severance Hospital; 🇰🇷 Seoul, Korea, Republic of