Using a MEMO wearable patch to find atrial fibrillation after an unexplained stroke
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
This trial will try a wearable single-lead ECG patch (MEMO Patch) to find previously missed atrial fibrillation in adults who had an embolic stroke of unknown cause.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Asan Medical Center Academic / other |
| Locations | 1 site (Seoul, Songpa-gu) |
| Trial ID | NCT07295769 on ClinicalTrials.gov |
What this trial studies
This is a prospective, single-center exploratory trial enrolling about 100 adults with embolic stroke of undetermined source (ESUS). Participants will undergo in-hospital telemetry monitoring with the MEMO Patch M and MEMO Cue for 12 hours up to 8 days alongside a 24-hour Holter, and investigators will review results to decide if an implantable loop recorder (ILR) is needed. At discharge all participants will wear MEMO Patch2 for up to 14 days for outpatient ECG monitoring, and results will be reviewed about one month later. The protocol is designed to determine how well the wearable patches detect previously undiagnosed atrial fibrillation and to inform ILR use.
Who should consider this trial
Good fit: Adults aged 19 or older with an embolic stroke of undetermined source who need ECG monitoring and can give informed consent are appropriate candidates.
Not a fit: People already known to have atrial fibrillation or atrial flutter, those with a clear cause of their stroke, those allergic to adhesives or hydrogels, or those unable to consent are unlikely to benefit from enrollment.
Why it matters
Potential benefit: If successful, the device could help find hidden atrial fibrillation so patients can get anticoagulation and potentially reduce their risk of another stroke.
How similar studies have performed: Previous studies of prolonged ECG monitoring and wearable patches have increased atrial fibrillation detection compared with short-term monitoring, though implantable loop recorders remain the most sensitive method.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Participants may take part in this clinical study only if they meet all of the following criteria: 1. Adults aged 19 years or older who voluntarily provide written informed consent to participate in the study 2. Patients diagnosed with ESUS (Embolic Stroke of Undetermined Source) 3. 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: 1. Individuals already diagnosed with atrial fibrillation or atrial flutter 2. Individuals with a clearly identified cause of stroke 3. Individuals known to have allergic reactions to adhesives or hydrogels 4. Individuals who, in the investigator's judgment, have cognitive vulnerability that makes it difficult to understand the study information and voluntarily decide on participation 5. Any other individuals whom the principal investigator considers to be at potential risk by participating in the study or otherwise unsuitable for participation
Where this trial is running
Seoul, Songpa-gu
- Asan Medical Center — Seoul, Songpa-gu, South Korea (Recruiting)
Study contacts
- Principal investigator: Bum Joon Kim — Asan Medical Center
- Study coordinator: Bum Joon Kim
- Email: medicj80@hanmail.net
- Phone: +82 02-3010-3981
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.