RecruitingNot ApplicableNCT07295769

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

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

Sponsor

Asan Medical Center

Enrollment

100 participants

Start Date

Jan 28, 2026

Study Type

INTERVENTIONAL

Conditions

Embolic Stroke of Undetermined Source

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.

Eligibility

Min Age: 19 Years

Inclusion Criteria4

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

Exclusion Criteria6

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

Interventions

DEVICEMEMO Patch M and MEMO Patch2

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.