Atrial Fibrillation Detection Using MEMO Patch in Patients With Stroke of Unknown Cause
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorAsan Medical Center
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
MEMO Patch M and MEMO Patch2
DeviceDuring 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.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: MEMO Patch Long-Term Monitoring(MEMO Patch M, MEMO Patch2)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Detection rate of Atrial Fibrillation (%)
The detection rate of atrial fibrillation (AF) will be evaluated based on MEMO Patch M during telemetry monitoring and 24-hour Holter monitoring. The AF detection rate by MEMO Patch M will be calculated as the number and percentage of participants in whom AF is detected at least once either through alarms or analysis results. The AF detection rate by 24-hour Holter will be calculated as the number and percentage of participants in whom AF is detected at least once during Holter analysis. The final determination of atrial fibrillation will be made according to the investigator's interpretation.
Time frame
During V1 (Day 0 to Day 8)Secondary outcomes
1
Time of Atrial Fibrillation (AF) detection
The timing of AF detection will be evaluated based on the results from MEMO Patch2 and ILR. This evaluation will be conducted only for patients who did not have AF detected during in-hospital telemetry monitoring and subsequently received ILR implantation.
Time frame
30 days (+7 days) and 90 days (+7 days) post-discharge (discharge = up to Day 8)2
Accuracy of in-hospital monitoring alarms
For participants who triggered an AF alarm during in-hospital monitoring, the alarm accuracy will be evaluated by comparison with the final analysis results, and performance metrics such as sensitivity will be calculated. * True Positive (TP): AF actually occurred and the alarm was triggered. * False Negative (FN): AF actually occurred, but no alarm was triggered. * False Positive (FP): AF did not occur, but an alarm was triggered. * True Negative (TN): AF did not occur and no alarm was triggered.
Time frame
During V1 (Day 0 to Day 8)3
AF detection rate and burden during out-of-hospital MEMO Patch2 monitoring
For patients discharged without ILR implantation, additional AF detection rate and burden will be evaluated using MEMO Patch2 at Visit 2 and Visit 3.
Time frame
30 days (+7 days) and 90 days (+7 days) post-discharge (discharge = up to Day 8)4
Detection rate of non-AF arrhythmias
The detection rate of arrhythmias other than AF will be analyzed in all participants regardless of AF detection. The following types of non-AF arrhythmias will be included: * Atrial Premature Contractions (APC) * Ventricular Premature Contractions (VPC) * Supraventricular Tachycardia (SVT): Defined as three or more consecutive APCs. * Ventricular Tachycardia (VT): Defined as three or more consecutive VPCs. * Atrioventricular Block (AV Block): Includes second-degree and third-degree AV block. * Pause: Defined as an R-R interval of more than 2 seconds. * Other: Arrhythmias not included in the above categories.
Time frame
During V1 (Day 0-8), 30 days (+7 days) and 90 days (+7 days) post-discharge (discharge = up to Day 8)Sponsors and contacts
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Source ClinicalTrials.gov