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

NCT07295769 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-02-06

No results posted yet for this study

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

Interventions

DEVICE

MEMO 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.

Sponsors & Collaborators

  • Asan Medical Center

    lead OTHER

Principal Investigators

  • Bum Joon Kim · Asan Medical Center

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-28
Primary Completion
2028-05-15
Completion
2029-02-15

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07295769 on ClinicalTrials.gov