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

Plain Language Summary

Simplified for easier understanding

This study tests a wearable heart monitor (the MEMO Patch) to detect irregular heart rhythm (atrial fibrillation) in patients who had a stroke of unknown cause, helping doctors understand if an irregular heartbeat was responsible. **You may be eligible if...** - You are 19 or older - You have been diagnosed with ESUS — a stroke that occurred due to a blood clot but whose cause could not be determined - You are willing to wear a heart monitor patch for an extended period **You may NOT be eligible if...** - You already have a known diagnosis of atrial fibrillation - You have a pacemaker or implanted heart device - You had a stroke caused by a known source (such as a blocked artery in the neck) - You have a skin condition or allergy that prevents wearing an adhesive patch Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.