Cryptogenic Ischemic Stroke, Dizziness, Palpitations, Suspected Arrhythmia, Transient Ischemic Attack
Conditions
Keywords
arrhythmia, ECG, electrocardiography, wearable ECG, patch ECG, MEMO Patch V2, Holter monitor, palpitations, dizziness
Brief summary
This exploratory medical device study evaluated the arrhythmia diagnostic yield of MEMO Patch V2, a wearable patch-type electrocardiographic monitor, in adults with suspected arrhythmia who presented with symptoms such as palpitations or dizziness, or who had cryptogenic ischemic stroke or transient ischemic attack. The diagnostic yield of MEMO Patch V2 was compared with that of conventional 24-hour ambulatory electrocardiography (Holter monitoring). The study also assessed ECG signal quality, participant compliance, usability and satisfaction, and skin-related adverse events. The findings were intended to provide preliminary data for planning a future large-scale clinical study.
Detailed description
This was a multicenter, non-randomized, controlled, open-label pilot clinical trial conducted at Korea University Anam Hospital and Seoul National University Bundang Hospital. Adults aged 19 to 80 years who required ECG monitoring because of suspected arrhythmia associated with palpitations or dizziness, or because of cryptogenic ischemic stroke or transient ischemic attack, were eligible. All participants underwent simultaneous application of a conventional 24-hour Holter monitor and MEMO Patch V2 on Day 0. The Holter monitor was removed and returned on Day 1, while MEMO Patch V2 continuously recorded a single-channel ECG for up to 14 days and was returned by courier. Participants attended an end-of-study visit on Day 21 ± 3 days. Effectiveness was evaluated by comparing arrhythmia detection rates and by assessing ECG signal quality, participant compliance, and device usability and satisfaction. Safety was evaluated based on skin-related adverse events occurring at the application site. A total of 150 participants were enrolled; the Full Analysis Set included 147 participants, the Per-Protocol Set included 141 participants, and the Safety Set included 150 participants.
Interventions
DEVICEMEMO Patch V2
MEMO Patch V2 is a wearable, single-channel patch-type ECG monitoring device intended for long-term ambulatory ECG recording. The device was applied on Day 0 and used for continuous ECG monitoring for up to 14 days. ECG data were stored and transferred for review through the MEMO ECG Webviewer. Electrode patches were replaced every 24 hours, and the device was returned by courier after monitoring.
DEVICE24-Hour Holter Monitor
A conventional ambulatory electrocardiographic monitor was applied simultaneously with MEMO Patch V2 on Day 0 and used for continuous ECG recording for approximately 24 hours. The device was removed and returned at the clinical site on Day 1.
Sponsors
HUINNO Co., Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
All participants underwent simultaneous monitoring with MEMO Patch V2 and a conventional 24-hour Holter monitor. Within-participant diagnostic yields were compared.
Eligibility
Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Adults aged 19 to 80 years. 2. Participants who required ECG monitoring because of suspected arrhythmia associated with symptoms such as palpitations or dizziness; or participants with cryptogenic ischemic stroke or transient ischemic attack. 3. Participants able to wear MEMO Patch V2 for 14 days. 4. Participants who received a detailed explanation of the study, fully understood it, and voluntarily provided written informed consent.
Exclusion criteria
1. History of allergic reactions to adhesive products. 2. Participants who required inpatient management during the study because of atrial fibrillation, stroke, transient ischemic attack, another clinically significant condition as determined by the investigator, or a history of dehydration or syncope within 1 year before screening. 3. Any other condition that, in the investigator's judgment, made the participant unsuitable for study participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Arrhythmia Detection Rate (%) | From device application on Day 0 through completion of MEMO Patch V2 monitoring, up to 14 days | The proportion of participants diagnosed with at least one arrhythmia using MEMO Patch V2 was compared with the proportion diagnosed using the 24-hour Holter monitor. Arrhythmias included premature atrial contraction, premature ventricular contraction, atrial tachycardia, atrial flutter, atrial fibrillation, paroxysmal supraventricular tachycardia, ventricular tachycardia, second- or third-degree atrioventricular block, sinus pause, and other arrhythmias. Comparisons included the total monitoring periods (Holter: 24 hours; MEMO Patch V2: at least 7 days) and the first 24 hours for both devices. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ECG Signal Quality | Up to 14 days | The percentage of analyzable MEMO Patch V2 recording time after excluding noise signals. |
| Participant Compliance | Up to 14 days | Compliance was calculated as actual wear time, excluding lead-off time, divided by the required total wear time of 336 hours, multiplied by 100. |
| Usability and Satisfaction | Day 21 ± 3 days | A 10-item questionnaire was scored on a 5-point scale and converted to a total score ranging from 0 to 100. |
Countries
South Korea
Contacts
PRINCIPAL_INVESTIGATORJong-Il Choi
MD, Division of Cardiology, Korea University Anam Hospital
PRINCIPAL_INVESTIGATORIl-Young Oh
MD, Division of Cardiology, Seoul National University Bundang Hospital
Outcome results
None listed