Embolic Stroke of Undetermined SourceNCT07295769
Atrial Fibrillation Detection Using MEMO Patch in Patients With Stroke of Unknown Cause
A study testing MEMO Patch M and MEMO Patch2 in people with Embolic Stroke of Undetermined Source, run by Asan Medical Center at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of a wearable device in detecting previously undiagnosed atrial fibrillation through non-invasive long-term monitoring using a wearable single-lead ECG patch (MEMO Patch M, MEMO Patch2) in 100 patients with Embolic Stroke of Undetermined Source (ESUS)… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Embolic Stroke of Undetermined Source
- What is being tested?
- MEMO Patch M and MEMO Patch2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 28 Jan 2026to 15 Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Participants may take part in this clinical study only if they meet all of the following criteria:
- Adults aged 19 years or older who voluntarily provide written informed consent to participate in the study
- Patients diagnosed with ESUS (Embolic Stroke of Undetermined Source)
- Patients who require in-hospital or out-of-hospital electrocardiographic (ECG) monitoring
Who cannot join
- Participants who meet any of the following criteria cannot be enrolled in this clinical study:
- Individuals already diagnosed with atrial fibrillation or atrial flutter
- Individuals with a clearly identified cause of stroke
- Individuals known to have allergic reactions to adhesives or hydrogels
- Individuals who, in the investigator's judgment, have cognitive vulnerability that makes it difficult to understand the study information and voluntarily decide on participation
- Any other individuals whom the principal investigator considers to be at potential risk by participating in the study or otherwise unsuitable for participation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Asan Medical Center
Seoul, Songpa-gu, 05505
Bum Joon Kim, MD, PhD, +82-2-3010-3981, medicj80@hanmail.net
About this study
Official title: Atrial Fibrillation Detection Using MEMO Patch in Patients With Stroke of Unknown Cause: A Single-Center, Prospective, Exploratory Trial to Validate the Efficacy and Safety of Noninvasive Long-Term Electrocardiographic Monitoring
The purpose of this study is to evaluate the efficacy and safety of a wearable device in detecting previously undiagnosed atrial fibrillation through non-invasive long-term monitoring using a wearable single-lead ECG patch (MEMO Patch M, MEMO Patch2) in 100 patients with Embolic Stroke of Undetermined Source (ESUS) who require atrial fibrillation screening. Participants who meet all inclusion and exclusion criteria and provide written informed consent will wear the MEMO Patch M and undergo in-hospital telemetry monitoring using MEMO Cue for a minimum of 12 hours and up to 8 days. During hospitalization, 24-hour Holter monitoring will also be conducted. Before discharge, the investigator will review these results to determine whether implantable loop recorder (ILR) implantation is necessary. At the time of discharge, participants will wear MEMO Patch2 for up to 14 days for the first ECG monitoring period. One month after discharge, the investigator will review the results of the first monitoring and initiate the second ECG monitoring with MEMO Patch2. Three months after discharge, the results of the second ECG monitoring will be reviewed, and participation in the clinical trial will be completed.
Read the detailed description
This clinical study is designed as a prospective, single-center, investigator-initiated exploratory clinical trial.
- Screening Participants will be assigned a screening number in the order in which informed consent is obtained. Through interviews and review of previous medical records, demographic information, medical history, surgical/procedural history, prior medications, and other required assessment items will be collected. Eligibility for study participation will be determined by reviewing the inclusion and exclusion criteria.
- Visit 1 (In-Hospital Telemetry Monitoring) Eligible participants will be fitted with the investigational medical device, MEMO Patch M, and will undergo in-hospital telemetry monitoring using MEMO Cue for a minimum of 12 hours and up to 8 days. A 24-hour Holter monitor will also be applied after admission. Prior to discharge, participants will review the MEMO Patch M (in-hospital telemetry) results to determine whether ILR implantation is required.
- Discharge (First ECG Monitoring) At discharge, participants who were not detected with atrial fibrillation using the Holter ECG or MEMO Patch M will receive an Implantable Loop Recorder (ILR). Participants in whom atrial fibrillation is detected will not receive ILR implantation. Regardless of ILR implantation, all participants will wear MEMO Patch2 and undergo additional ECG monitoring for up to 14 days after discharge. After the scheduled monitoring period ends, MEMO Patch2 will be returned using the Huinno courier service.
- Visit 2 (Review of First ECG Monitoring Results - 1-Month Visit) At the 1-month outpatient visit, participants will review the results of the first ECG monitoring. They will then undergo a second monitoring period by wearing MEMO Patch2 for up to 14 days. After completing the scheduled monitoring period, MEMO Patch2 will be returned using the Huinno courier service.
- Visit 3 (Review of Second ECG Monitoring Results - 3-Month Visit) At the 3-month outpatient visit, participants will review the results of the second ECG monitoring. After this visit, participation in the clinical study will be completed.
- Conditions
- Embolic Stroke of Undetermined Source
- Being tested
- MEMO Patch M and MEMO Patch2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEMO Patch M and MEMO Patch2Device
During hospitalization, participants will wear MEMO Patch M, a single-lead wearable ECG patch, for 12 hours to up to 8 days. A 24-hour Holter monitor will also be performed during hospitalization. Before discharge, investigators will review the MEMO Patch M and Holter results to assess the need for implantable loop recorder (ILR) implantation. At the time of discharge, participants will wear MEMO Patch2 for up to 14 days for the first ECG monitoring period. One month after discharge, participants will undergo the second ECG monitoring period with MEMO Patch2 for up to 14 days.
| Study group | Role | What they receive |
|---|---|---|
| MEMO Patch Long-Term Monitoring(MEMO Patch M, MEMO Patch2) | Experimental | Participants in this arm will undergo long-term ECG monitoring using MEMO Patch M during hospitalization and MEMO Patch2 after discharge. 24-hour Holter monitoring will also be performed, and ILR implantation will be assessed before discharge. Receives: Device: MEMO Patch M and MEMO Patch2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection rate of Atrial Fibrillation (%)
The detection rate of atrial fibrillation (AF) will be evaluated based on MEMO Patch M during telemetry monitoring and 24-hour Holter monitoring. The AF detection rate by MEMO Patch M will be calculated as the number and percentage of participants in whom AF is detected at least once either through alarms or analysis results. The AF detection rate by 24-hour Holter will be calculated as the number and percentage of participants in whom AF is detected at least once during Holter analysis. The final determination of atrial fibrillation will be made according to the investigator's interpretation.
Measured: During V1 (Day 0 to Day 8)
Secondary outcomes (8)
Time of Atrial Fibrillation (AF) detection
The timing of AF detection will be evaluated based on the results from MEMO Patch2 and ILR. This evaluation will be conducted only for patients who did not have AF detected during in-hospital telemetry monitoring and subsequently received ILR implantation.
Measured: 30 days (+7 days) and 90 days (+7 days) post-discharge (discharge = up to Day 8)
Accuracy of in-hospital monitoring alarms
For participants who triggered an AF alarm during in-hospital monitoring, the alarm accuracy will be evaluated by comparison with the final analysis results, and performance metrics such as sensitivity will be calculated.
- True Positive (TP): AF actually occurred and the alarm was triggered.
- False Negative (FN): AF actually occurred, but no alarm was triggered.
- False Positive (FP): AF did not occur, but an alarm was triggered.
- True Negative (TN): AF did not occur and no alarm was triggered.
Measured: During V1 (Day 0 to Day 8)
AF detection rate and burden during out-of-hospital MEMO Patch2 monitoring
For patients discharged without ILR implantation, additional AF detection rate and burden will be evaluated using MEMO Patch2 at Visit 2 and Visit 3.
Measured: 30 days (+7 days) and 90 days (+7 days) post-discharge (discharge = up to Day 8)
Detection rate of non-AF arrhythmias
The detection rate of arrhythmias other than AF will be analyzed in all participants regardless of AF detection. The following types of non-AF arrhythmias will be included:
- Atrial Premature Contractions (APC)
- Ventricular Premature Contractions (VPC)
- Supraventricular Tachycardia (SVT): Defined as three or more consecutive APCs.
- Ventricular Tachycardia (VT): Defined as three or more consecutive VPCs.
- Atrioventricular Block (AV Block): Includes second-degree and third-degree AV block.
- Pause: Defined as an R-R interval of more than 2 seconds.
- Other: Arrhythmias not included in the above categories.
Measured: During V1 (Day 0-8), 30 days (+7 days) and 90 days (+7 days) post-discharge (discharge = up to Day 8)
Analysis of arrhythmia types including AF
In participants in whom arrhythmias, including atrial fibrillation, were detected, the type of each arrhythmia will be evaluated. (including its duration and burden)
Measured: During V1 (Day 0-8), 30 days (+7 days) and 90 days (+7 days) post-discharge (discharge = up to Day 8)
Risk factor analysis for AF occurrence
In participants with detected AF, ethe type of each arrhythmia(duration, and burden), including AF, will be evaluated. 6) To analyze factors associated with AF occurrence in patients with Embolic Stroke of Undetermined Source (ESUS), the following parameters will be assessed:
- Frequency of Atrial Premature Contractions (APC)
- Age
- CHA₂DS₂-VA Score
- Left Atrial Size (LA diameter, LA volume index)
- Lesion Pattern
- Laboratory Test Results
- Risk factors will be analyzed post hoc only for participants with available data.
Measured: Screening (Day-28 to Day 0), 30 days (+7 days) and 90 days (+7 days) post-discharge (discharge = up to Day 8)
Rate and timing of treatment strategy changes (Including medication and procedures) after AF diagnosis
In participants who were receiving standard treatment for ESUS, the proportion and timing of treatment changes will be analyzed if AF diagnosis via MEMO Patch monitoring led to:
- Initiation or switching of anticoagulant therapy
- Initiation or switching of antiarrhythmic drugs
- Catheter ablation or other procedure-related changes
Measured: During V1 (Day 0-8), 30 days (+7 days) and 90 days (+7 days) post-discharge (discharge = up to Day 8)
Comparison of AF detection rates and timing between two monitoring strategies (MEMO Patch M + MEMO Patch2 vs. Holter + ILR)
The AF detection rate and timing will be compared between MEMO Patch M and MEMO Patch2 versus Holter and ILR during in-hospital and out-of-hospital monitoring.
Measured: During V1 (Day 0-8), 30 days (+7 days) and 90 days (+7 days) post-discharge (discharge = up to Day 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2025
- Study start28 Jan 2026
- Primary completion15 May 2028 (estimated)
- Study completion15 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Embolic Stroke of Undetermined SourceStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bum Joon Kim, Asan Medical Center
- Investigators
- Bum Joon Kim, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07295769
- Sponsor's protocol ID
- MEMO-ESUS
- Status last verified
- Feb 2026
- First submitted
- 26 Nov 2025
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lumikari TJ, Putaala J, Kerola A, Sibolt G, Pirinen J, Pakarinen S, Lehto M, Nieminen T. Continuous 4-week ECG monitoring with adhesive electrodes reveals AF in patients with recent embolic stroke of undetermined source. Ann Noninvasive Electrocardiol. 2019 Sep;24(5):e12649. doi: 10.1111/anec.12649. Epub 2019 May 2.
PubMed 31045315Gladstone DJ, Spring M, Dorian P, Panzov V, Thorpe KE, Hall J, Vaid H, O'Donnell M, Laupacis A, Cote R, Sharma M, Blakely JA, Shuaib A, Hachinski V, Coutts SB, Sahlas DJ, Teal P, Yip S, Spence JD, Buck B, Verreault S, Casaubon LK, Penn A, Selchen D, Jin A, Howse D, Mehdiratta M, Boyle K, Aviv R, Kapral MK, Mamdani M; EMBRACE Investigators and Coordinators. Atrial fibrillation in patients with cryptogenic stroke. N Engl J Med. 2014 Jun 26;370(26):2467-77. doi: 10.1056/NEJMoa1311376.
PubMed 24963566Sanna T, Diener HC, Passman RS, Di Lazzaro V, Bernstein RA, Morillo CA, Rymer MM, Thijs V, Rogers T, Beckers F, Lindborg K, Brachmann J; CRYSTAL AF Investigators. Cryptogenic stroke and underlying atrial fibrillation. N Engl J Med. 2014 Jun 26;370(26):2478-86. doi: 10.1056/NEJMoa1313600.
PubMed 24963567Kulach A, Dewerenda M, Majewski M, Lasek-Bal A, Gasior Z. 72 hour Holter monitoring, 7 day Holter monitoring, and 30 day intermittent patient-activated heart rhythm recording in detecting arrhythmias in cryptogenic stroke patients free from arrhythmia in a screening 24 h Holter. Open Med (Wars). 2020 Jul 18;15(1):697-701. doi: 10.1515/med-2020-0203. eCollection 2020.
PubMed 33336026Ramos-Maqueda J, Navarro-Valverde C, Esteve-Ruiz I, Cabrera-Ramos M, Rivera-Lopez R, Garcia-Medina D, Pavon-Jimenez R, Molano-Casimiro FJ. Atrial fibrillation predictors in patients with embolic stroke of undetermined source. Med Clin (Barc). 2021 Dec 24;157(12):555-560. doi: 10.1016/j.medcli.2020.09.024. Epub 2021 Jan 29. English, Spanish.
PubMed 33518373Miyazaki Y, Toyoda K, Iguchi Y, Hirano T, Metoki N, Tomoda M, Shiozawa M, Koge J, Okada Y, Terasawa Y, Kikuno M, Okano H, Hagii J, Nakajima M, Komatsu T, Yasaka M. Atrial Fibrillation After Ischemic Stroke Detected by Chest Strap-Style 7-Day Holter Monitoring and the Risk Predictors: EDUCATE-ESUS. J Atheroscler Thromb. 2021 May 1;28(5):544-554. doi: 10.5551/jat.58420. Epub 2020 Aug 15.
PubMed 32801289Hart RG, Catanese L, Perera KS, Ntaios G, Connolly SJ. Embolic Stroke of Undetermined Source: A Systematic Review and Clinical Update. Stroke. 2017 Apr;48(4):867-872. doi: 10.1161/STROKEAHA.116.016414. Epub 2017 Mar 6.
PubMed 28265016Kleindorfer DO, Towfighi A, Chaturvedi S, Cockroft KM, Gutierrez J, Lombardi-Hill D, Kamel H, Kernan WN, Kittner SJ, Leira EC, Lennon O, Meschia JF, Nguyen TN, Pollak PM, Santangeli P, Sharrief AZ, Smith SC Jr, Turan TN, Williams LS. 2021 Guideline for the Prevention of Stroke in Patients With Stroke and Transient Ischemic Attack: A Guideline From the American Heart Association/American Stroke Association. Stroke. 2021 Jul;52(7):e364-e467. doi: 10.1161/STR.0000000000000375. Epub 2021 May 24. No abstract available.
PubMed 34024117Diener HC, Sacco RL, Easton JD, Granger CB, Bernstein RA, Uchiyama S, Kreuzer J, Cronin L, Cotton D, Grauer C, Brueckmann M, Chernyatina M, Donnan G, Ferro JM, Grond M, Kallmunzer B, Krupinski J, Lee BC, Lemmens R, Masjuan J, Odinak M, Saver JL, Schellinger PD, Toni D, Toyoda K; RE-SPECT ESUS Steering Committee and Investigators. Dabigatran for Prevention of Stroke after Embolic Stroke of Undetermined Source. N Engl J Med. 2019 May 16;380(20):1906-1917. doi: 10.1056/NEJMoa1813959.
PubMed 31091372
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atrial Fibrillation Detection Using MEMO Patch in Patients With Stroke of Unknown Cause: A Single-Center, Prospective, Exploratory Trial to Validate the Efficacy and Safety of Noninvasive Long-Term Electrocardiographic Monitoring
- ClinicalTrials.gov ID
- NCT07295769
- Acronym / sponsor ID
- MEMO-ESUS
- Conditions
- Embolic Stroke of Undetermined Source
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 28 Jan 2026 (actual)
- Primary completion
- 15 May 2028 (estimated)
- Study completion
- 15 Feb 2029 (estimated)
- First posted
- 22 Dec 2025 (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 efficacy and safety of a wearable device in detecting previously undiagnosed atrial fibrillation through non-invasive long-term monitoring using a wearable single-lead ECG patch (MEMO Patch M, MEMO Patch2) in 100 patients with Embolic Stroke of Undetermined Source (ESUS) who require atrial fibrillation screening. Participants who meet all inclusion and exclusion criteria and provide written informed consent will wear the MEMO Patch M and undergo in-hospital telemetry monitoring using MEMO Cue for a minimum of 12 hours and up to 8 days. During hospitalization, 24-hour Holter monitoring will also be conducted. Before discharge, the investigator will review these results to determine whether implantable loop recorder (ILR) implantation is necessary. At the time of discharge, participants will wear MEMO Patch2 for up to 14 days for the first ECG monitoring period. One month after discharge, the investigator will review the results of the first monitoring and initiate the second ECG monitoring with MEMO Patch2. Three months after discharge, the results of the second ECG monitoring will be reviewed, and participation in the clinical trial will be completed.
Detailed description
This clinical study is designed as a prospective, single-center, investigator-initiated exploratory clinical trial.
- Screening Participants will be assigned a screening number in the order in which informed consent is obtained. Through interviews and review of previous medical records, demographic information, medical history, surgical/procedural history, prior medications, and other required assessment items will be collected. Eligibility for study participation will be determined by reviewing the inclusion and exclusion criteria.
- Visit 1 (In-Hospital Telemetry Monitoring) Eligible participants will be fitted with the investigational medical device, MEMO Patch M, and will undergo in-hospital telemetry monitoring using MEMO Cue for a minimum of 12 hours and up to 8 days. A 24-hour Holter monitor will also be applied after admission. Prior to discharge, participants will review the MEMO Patch M (in-hospital telemetry) results to determine whether ILR implantation is required.
- Discharge (First ECG Monitoring) At discharge, participants who were not detected with atrial fibrillation using the Holter ECG or MEMO Patch M will receive an Implantable Loop Recorder (ILR). Participants in whom atrial fibrillation is detected will not receive ILR implantation. Regardless of ILR implantation, all participants will wear MEMO Patch2 and undergo additional ECG monitoring for up to 14 days after discharge. After the scheduled monitoring period ends, MEMO Patch2 will be returned using the Huinno courier service.
- Visit 2 (Review of First ECG Monitoring Results - 1-Month Visit) At the 1-month outpatient visit, participants will review the results of the first ECG monitoring. They will then undergo a second monitoring period by wearing MEMO Patch2 for up to 14 days. After completing the scheduled monitoring period, MEMO Patch2 will be returned using the Huinno courier service.
- Visit 3 (Review of Second ECG Monitoring Results - 3-Month Visit) At the 3-month outpatient visit, participants will review the results of the second ECG monitoring. After this visit, participation in the clinical study will be completed.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MEMO Patch Long-Term Monitoring(MEMO Patch M, MEMO Patch2) | Experimental | Device: MEMO Patch M and MEMO Patch2Participants in this arm will undergo long-term ECG monitoring using MEMO Patch M during hospitalization and MEMO Patch2 after discharge. 24-hour Holter monitoring will also be performed, and ILR implantation will be assessed before discharge. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants may take part in this clinical study only if they meet all of the following criteria:
- Adults aged 19 years or older who voluntarily provide written informed consent to participate in the study
- Patients diagnosed with ESUS (Embolic Stroke of Undetermined Source)
- Patients who require in-hospital or out-of-hospital electrocardiographic (ECG) monitoring
Key exclusion criteria (6 listed)
- Participants who meet any of the following criteria cannot be enrolled in this clinical study:
- Individuals already diagnosed with atrial fibrillation or atrial flutter
- Individuals with a clearly identified cause of stroke
- Individuals known to have allergic reactions to adhesives or hydrogels
- Individuals who, in the investigator's judgment, have cognitive vulnerability that makes it difficult to understand the study information and voluntarily decide on participation
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 M and MEMO Patch2During hospitalization, participants will wear MEMO Patch M, a single-lead wearable ECG patch, for 12 hours to up to 8 days. A 24-hour Holter monitor will also be performed during hospitalization. Before discharge, investigators will review the MEMO Patch M and Holter results to assess the need for implantable loop recorder (ILR) implantation. At the time of discharge, participants will wear MEMO Patch2 for up to 14 days for the first ECG monitoring period. One month after discharge, participants will undergo the second ECG monitoring period with MEMO Patch2 for up to 14 days. | Device | MEMO Patch Long-Term Monitoring(MEMO Patch M, MEMO Patch2) |
Primary outcome
Detection rate of Atrial Fibrillation (%)
Time frame: During V1 (Day 0 to Day 8)
The detection rate of atrial fibrillation (AF) will be evaluated based on MEMO Patch M during telemetry monitoring and 24-hour Holter monitoring. The AF detection rate by MEMO Patch M will be calculated as the number and percentage of participants in whom AF is detected at least once either through alarms or analysis results. The AF detection rate by 24-hour Holter will be calculated as the number and percentage of participants in whom AF is detected at least once during Holter analysis. The final determination of atrial fibrillation will be made according to the investigator's interpretation.
8 secondary outcomes
Time of Atrial Fibrillation (AF) detection
Time frame: 30 days (+7 days) and 90 days (+7 days) post-discharge (discharge = up to Day 8)
Accuracy of in-hospital monitoring alarms
Time frame: During V1 (Day 0 to Day 8)
AF detection rate and burden during out-of-hospital MEMO Patch2 monitoring
Time frame: 30 days (+7 days) and 90 days (+7 days) post-discharge (discharge = up to Day 8)
Detection rate of non-AF arrhythmias
Time frame: During V1 (Day 0-8), 30 days (+7 days) and 90 days (+7 days) post-discharge (discharge = up to Day 8)
Analysis of arrhythmia types including AF
Time frame: During V1 (Day 0-8), 30 days (+7 days) and 90 days (+7 days) post-discharge (discharge = up to Day 8)
Risk factor analysis for AF occurrence
Time frame: Screening (Day-28 to Day 0), 30 days (+7 days) and 90 days (+7 days) post-discharge (discharge = up to Day 8)
Rate and timing of treatment strategy changes (Including medication and procedures) after AF diagnosis
Time frame: During V1 (Day 0-8), 30 days (+7 days) and 90 days (+7 days) post-discharge (discharge = up to Day 8)
Comparison of AF detection rates and timing between two monitoring strategies (MEMO Patch M + MEMO Patch2 vs. Holter + ILR)
Time frame: During V1 (Day 0-8), 30 days (+7 days) and 90 days (+7 days) post-discharge (discharge = up to Day 8)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Background: PubMed 31045315Lumikari TJ, Putaala J, Kerola A, Sibolt G, Pirinen J, Pakarinen S, Lehto M, Nieminen T. Continuous 4-week ECG monitoring with adhesive electrodes reveals AF in patients with recent embolic stroke of undetermined source. Ann Noninvasive Electrocardiol. 2019 Sep;24(5):e12649. doi: 10.1111/anec.12649. Epub 2019 May 2.
- Background: PubMed 24963566Gladstone DJ, Spring M, Dorian P, Panzov V, Thorpe KE, Hall J, Vaid H, O'Donnell M, Laupacis A, Cote R, Sharma M, Blakely JA, Shuaib A, Hachinski V, Coutts SB, Sahlas DJ, Teal P, Yip S, Spence JD, Buck B, Verreault S, Casaubon LK, Penn A, Selchen D, Jin A, Howse D, Mehdiratta M, Boyle K, Aviv R, Kapral MK, Mamdani M; EMBRACE Investigators and Coordinators. Atrial fibrillation in patients with cryptogenic stroke. N Engl J Med. 2014 Jun 26;370(26):2467-77. doi: 10.1056/NEJMoa1311376.
- Background: PubMed 24963567Sanna T, Diener HC, Passman RS, Di Lazzaro V, Bernstein RA, Morillo CA, Rymer MM, Thijs V, Rogers T, Beckers F, Lindborg K, Brachmann J; CRYSTAL AF Investigators. Cryptogenic stroke and underlying atrial fibrillation. N Engl J Med. 2014 Jun 26;370(26):2478-86. doi: 10.1056/NEJMoa1313600.
- Background: PubMed 33336026Kulach A, Dewerenda M, Majewski M, Lasek-Bal A, Gasior Z. 72 hour Holter monitoring, 7 day Holter monitoring, and 30 day intermittent patient-activated heart rhythm recording in detecting arrhythmias in cryptogenic stroke patients free from arrhythmia in a screening 24 h Holter. Open Med (Wars). 2020 Jul 18;15(1):697-701. doi: 10.1515/med-2020-0203. eCollection 2020.
- Background: PubMed 33518373Ramos-Maqueda J, Navarro-Valverde C, Esteve-Ruiz I, Cabrera-Ramos M, Rivera-Lopez R, Garcia-Medina D, Pavon-Jimenez R, Molano-Casimiro FJ. Atrial fibrillation predictors in patients with embolic stroke of undetermined source. Med Clin (Barc). 2021 Dec 24;157(12):555-560. doi: 10.1016/j.medcli.2020.09.024. Epub 2021 Jan 29. English, Spanish.
- Background: PubMed 32801289Miyazaki Y, Toyoda K, Iguchi Y, Hirano T, Metoki N, Tomoda M, Shiozawa M, Koge J, Okada Y, Terasawa Y, Kikuno M, Okano H, Hagii J, Nakajima M, Komatsu T, Yasaka M. Atrial Fibrillation After Ischemic Stroke Detected by Chest Strap-Style 7-Day Holter Monitoring and the Risk Predictors: EDUCATE-ESUS. J Atheroscler Thromb. 2021 May 1;28(5):544-554. doi: 10.5551/jat.58420. Epub 2020 Aug 15.
- Background: PubMed 28265016Hart RG, Catanese L, Perera KS, Ntaios G, Connolly SJ. Embolic Stroke of Undetermined Source: A Systematic Review and Clinical Update. Stroke. 2017 Apr;48(4):867-872. doi: 10.1161/STROKEAHA.116.016414. Epub 2017 Mar 6.
- Background: PubMed 34024117Kleindorfer DO, Towfighi A, Chaturvedi S, Cockroft KM, Gutierrez J, Lombardi-Hill D, Kamel H, Kernan WN, Kittner SJ, Leira EC, Lennon O, Meschia JF, Nguyen TN, Pollak PM, Santangeli P, Sharrief AZ, Smith SC Jr, Turan TN, Williams LS. 2021 Guideline for the Prevention of Stroke in Patients With Stroke and Transient Ischemic Attack: A Guideline From the American Heart Association/American Stroke Association. Stroke. 2021 Jul;52(7):e364-e467. doi: 10.1161/STR.0000000000000375. Epub 2021 May 24. No abstract available.
- Background: PubMed 31091372Diener HC, Sacco RL, Easton JD, Granger CB, Bernstein RA, Uchiyama S, Kreuzer J, Cronin L, Cotton D, Grauer C, Brueckmann M, Chernyatina M, Donnan G, Ferro JM, Grond M, Kallmunzer B, Krupinski J, Lee BC, Lemmens R, Masjuan J, Odinak M, Saver JL, Schellinger PD, Toni D, Toyoda K; RE-SPECT ESUS Steering Committee and Investigators. Dabigatran for Prevention of Stroke after Embolic Stroke of Undetermined Source. N Engl J Med. 2019 May 16;380(20):1906-1917. doi: 10.1056/NEJMoa1813959.
- Individual participant dataSharing planned: No
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Paroxysmal Nocturnal Hemoglobinuria, Embolic Stroke of Undetermined Source
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SENIOR: Stroke Prevention in the Elderly by Patent Foramen Ovale closuRe vs Anticoagulation
Ischemic Stroke, Embolic Stroke of Undetermined Source
RecruitingObservational study
High Coverage CARotid Stenting vs. Medical Management Alone to Prevent EmboliSm From symptomaTic Non-stenotic cARotid Disease (SyNC)
Carotid Artery Disease, Symptomatic Carotid Artery Stenosis
RecruitingObservational study
AI-Based Prediction of Atrial Fibrillation in ESUS Patients With ICM
Embolic Stroke of Undetermined Source
RecruitingObservational study
Left Atrial Strain and Cryptogenic Stroke
Ischemic Stroke, Cryptogenic, Ischemic Stroke, Embolic
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.
Bum Joon Kim principal investigator
Asan Medical Center
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 M and MEMO Patch2 in people with Embolic Stroke of Undetermined Source, run by Asan Medical Center 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?
The sponsor lists 4 inclusion and 6 exclusion criteria. 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: looking for participants now, as of the sponsor's last update on 6 Feb 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bum Joon Kim (+82 02-3010-3981, medicj80@hanmail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection rate of Atrial Fibrillation (%) (time frame: During V1 (Day 0 to Day 8)). 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 NCT07295769, which also lists 9 linked publications.
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 6 Feb 2026.