Atrial Fibrillation Detection Using MEMO Patch in Patients With Stroke of Unknown Cause

NCT07295769 | Recruiting

• 1 other identifier: MEMO-ESUS
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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) 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.

Conditions

Embolic Stroke of Undetermined Source

Outcome Measures

Primary Outcomes (1)

• 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.

  During V1 (Day 0 to Day 8)

Secondary Outcomes (8)

• Time of Atrial Fibrillation (AF) detection

  30 days (+7 days) and 90 days (+7 days) post-discharge (discharge = up to Day 8)

• Accuracy of in-hospital monitoring alarms

  During V1 (Day 0 to Day 8)

• AF detection rate and burden during out-of-hospital MEMO Patch2 monitoring

  30 days (+7 days) and 90 days (+7 days) post-discharge (discharge = up to Day 8)

• Detection rate of non-AF arrhythmias

  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

  During V1 (Day 0-8), 30 days (+7 days) and 90 days (+7 days) post-discharge (discharge = up to Day 8)

Study Arms (1)

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.

Device: MEMO Patch M and MEMO Patch2

Interventions

MEMO Patch M and MEMO Patch2 DEVICE

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.

MEMO Patch Long-Term Monitoring(MEMO Patch M, MEMO Patch2)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical Center

Seoul, Songpa-gu, 05505, South Korea

RECRUITING

Related Publications (9)

• 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.

  PMID: 31045315 BACKGROUND

• Gladstone 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.

  PMID: 24963566 BACKGROUND

• Sanna 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.

  PMID: 24963567 BACKGROUND

• Kulach 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.

  PMID: 33336026 BACKGROUND

• Ramos-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.

  PMID: 33518373 BACKGROUND

• Miyazaki 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.

  PMID: 32801289 BACKGROUND

• Hart 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.

  PMID: 28265016 BACKGROUND

• Kleindorfer 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.

  PMID: 34024117 BACKGROUND

• Diener 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.

  PMID: 31091372 BACKGROUND

Study Officials

• Bum Joon Kim

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bum Joon Kim

CONTACT

+82 02-3010-3981; medicj80@hanmail.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 26, 2025
• First Posted: December 22, 2025
• Study Start: January 28, 2026
• Primary Completion (Estimated): May 15, 2028
• Study Completion (Estimated): February 15, 2029
• Last Updated: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)