Atrial Fibrillation/Flutter in Patients With High Risk of StrokeMEMO-DAF8NCT05355948
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
A study testing MEMO Patch PLUS for 1 day and MEMO Patch PLUS for More than 8-days in people with Atrial Fibrillation/Flutter in Patients With High Risk of Stroke, run by Yonsei University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Atrial Fibrillation/Flutter in Patients With High Risk of Stroke
- What is being tested?
- MEMO Patch PLUS for 1 day and MEMO Patch PLUS for More than 8-days
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 9 May 2022to 31 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
[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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Yonsei University Health System, Severance Hospital
Seoul
About this study
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
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.
- Being tested
- MEMO Patch PLUS for 1 day, MEMO Patch PLUS for More than 8-days
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEMO Patch PLUS for 1 dayDevice
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.
MEMO Patch PLUS for More than 8-daysDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| MEMO Patch PLUS ECG monitoring for One-day | Experimental | Not described Receives: Device: MEMO Patch PLUS for 1 day |
| MEMO Patch PLUS ECG monitoring for More than 8-days | Experimental | Not described Receives: Device: MEMO Patch PLUS for More than 8-days |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 2 month(±Month 2)
Secondary outcomes (8)
Time to the first occurrence of atrial fibrillation/flutter lasting more than 30 seconds after MEMO Patch PLUS is attached.
Measured: 1month(+1month), 12 month(±Month 2)
Adaptation rate of anticoagulant or antiplatelet therapy when atrial fibrillation/flutter is diagnosed.
Measured: 1month(+1month), 12 month(±Month 2)
Time required to use or switch to anticoagulant or antiplatelet therapy after atrial fibrillation/flutter diagnosis.
Measured: 1month(+1month), 12 month(±Month 2)
Burden of total atrial fibrillation/flutter occurrence time
Measured: 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.
Measured: 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.
Measured: 1month(+1month), 12 month(±Month 2)
Distribution rate of wearing period of ECG monitoring group for more than 8 days.
Measured: 1month(+1month), 12 month(±Month 2)
Detection rate of other arrhythmias* except atrial fibrillation/flutter.
Measured: 1month(+1month), 12 month(±Month 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start9 May 2022
- Primary completion31 Jul 2023
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial Fibrillation/Flutter in Patients With High Risk of StrokeStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- None (open label)
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Boyoung Joung, Principal investigator, Severance Cardiovascular Hospital Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05355948
- Sponsor's protocol ID
- 1-2022-0008
- Acronym
- MEMO-DAF8
- Status last verified
- Jun 2026
- First submitted
- 21 Apr 2022
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41548032
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05355948
- Acronym / sponsor ID
- MEMO-DAF8 / 1-2022-0008
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 9 May 2022 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 2 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| MEMO Patch PLUS ECG monitoring for One-day | Experimental | Device: MEMO Patch PLUS for 1 day |
| MEMO Patch PLUS ECG monitoring for More than 8-days | Experimental | Device: MEMO Patch PLUS for More than 8-days |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MEMO Patch PLUS for 1 dayIndividuals 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. | Device | MEMO Patch PLUS ECG monitoring for One-day |
| MEMO Patch PLUS for More than 8-daysIndividuals 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. | Device | MEMO Patch PLUS ECG monitoring for More than 8-days |
Primary outcome
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.
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.
8 secondary outcomes
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)
Adaptation rate of anticoagulant or antiplatelet therapy when atrial fibrillation/flutter is diagnosed.
Time frame: 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)
Burden of total atrial fibrillation/flutter occurrence time
Time frame: 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)
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)
Distribution rate of wearing period of ECG monitoring group for more than 8 days.
Time frame: 1month(+1month), 12 month(±Month 2)
Detection rate of other arrhythmias* except atrial fibrillation/flutter.
Time frame: 1month(+1month), 12 month(±Month 2)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Derived from this study: PubMed 41548032Park 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boyoung Joung principal investigator
Severance Cardiovascular Hospital Yonsei University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MEMO Patch PLUS for 1 day and MEMO Patch PLUS for More than 8-days in people with Atrial Fibrillation/Flutter in Patients With High Risk of Stroke, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of newly diagnosed AF (time frame: 1 month(+1month)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05355948, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.