Atrial Fibrillation Detection Using MEMO Patch in Patients With Stroke of Unknown Cause
Recruiting · NCT07295769 · Interventional (participants receive a specific treatment) · Lead sponsor: Asan Medical Center
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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 criteria
- 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
Where it is running
1 location listed.
- Asan Medical Center - Seoul, Songpa-gu, South Korea