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 (MEMO-DAF8)
June 29, 2026 updated by: Yonsei University
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
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 Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
1000
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, South Korea
- Yonsei University Health System, Severance Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
[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 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: MEMO Patch PLUS ECG monitoring for One-day
|
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.
|
|
Experimental: MEMO Patch PLUS ECG monitoring for More than 8-days
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of newly diagnosed AF
Time Frame: 1 month(+1month)
|
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
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.
|
2 month(±Month 2)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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)
|
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)
|
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)
|
1month(+1month), 12 month(±Month 2)
|
|
Burden of total atrial fibrillation/flutter occurrence time
Time Frame: 1month(+1month), 12 month(±Month 2)
|
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)
|
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)
|
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)
|
1month(+1month), 12 month(±Month 2)
|
|
Detection rate of other arrhythmias* except atrial fibrillation/flutter.
Time Frame: 1month(+1month), 12 month(±Month 2)
|
1month(+1month), 12 month(±Month 2)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Boyoung Joung, Severance Cardiovascular Hospital Yonsei University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 9, 2022
Primary Completion (Actual)
July 31, 2023
Study Completion (Actual)
July 31, 2024
Study Registration Dates
First Submitted
April 21, 2022
First Submitted That Met QC Criteria
April 29, 2022
First Posted (Actual)
May 2, 2022
Study Record Updates
Last Update Posted (Actual)
July 1, 2026
Last Update Submitted That Met QC Criteria
June 29, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1-2022-0008
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.