Arrhythmia, Palpitations, Syncope
Conditions
Keywords
MEMO Patch, ECG Patch, Ambulatory ECG Monitoring, Holter Monitoring, Palpitations, Syncope, Wearable ECG, Long-term ECG Monitoring
Brief summary
"This exploratory prospective clinical study aims to evaluate the diagnostic yield of a 7-day adhesive electrocardiographic (ECG) monitoring device (MEMO Patch) in detecting cardiac arrhythmias in patients presenting with palpitations. Participants who require 24-hour Holter monitoring because of symptoms such as palpitations or dizziness will simultaneously wear a conventional 24-hour Holter monitor and the MEMO Patch. The Holter monitor will be removed after 24 hours, while the MEMO Patch will continue monitoring for a total of 7 days. ECG recordings will be evaluated by cardiologists after technical quality assessment. The study will assess arrhythmia detection, device-related skin adverse events, and participant usability and satisfaction."
Detailed description
"Patients aged 19 years or older who visit the study site with symptoms suggestive of arrhythmia and require 24-hour ambulatory ECG monitoring will be screened after providing written informed consent. At Visit 1, participants will simultaneously undergo conventional 24-hour Holter monitoring and 7-day ECG monitoring using the MEMO Patch. Participants will record the occurrence and timing of any symptoms in a symptom diary during the monitoring period. The Holter monitor will be returned after 24 hours. Participants will continue wearing the MEMO Patch for an additional six days and return the device by mail after completion of the 7-day monitoring period. After technical quality assessment, ECG recordings from both devices will be interpreted by cardiologists. Participants will return approximately one week after completion of monitoring to review the test results. Device usability and participant satisfaction will also be assessed using a questionnaire."
Interventions
DEVICEMEMO Patch
MEMO Patch is a wearable single-lead adhesive electrocardiographic (ECG) monitoring device for continuous ECG recording. The device is applied simultaneously with a conventional 24-hour Holter monitor at Visit 1 and is worn continuously for 7 days.
DEVICE24-Hour Holter Monitor
A conventional 24-hour ambulatory electrocardiographic (ECG) monitor is applied simultaneously with the MEMO Patch at Visit 1 and is used for continuous ECG recording for approximately 24 hours. The Holter monitor is removed at Visit 2.
Sponsors
HUINNO Co., Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
No masking was applied to participants or investigators.
Intervention model description
All enrolled participants underwent simultaneous monitoring with a conventional 24-hour Holter monitor and the MEMO Patch. The Holter monitor was removed after 24 hours, whereas the MEMO Patch continued ECG monitoring for 7 days. Diagnostic yields were compared within participants.
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants must meet all of the following criteria: 1. Adults aged 19 years or older who visit the study site during the study period with symptoms such as palpitations or syncope and are considered to require 24-hour ambulatory electrocardiographic monitoring. 2. Able and willing to provide voluntary written informed consent. 3. Able to wear the MEMO Patch™ continuously for 7 days.
Exclusion criteria
* Participants meeting any of the following criteria will be excluded: 1. A self-reported history of an allergic skin reaction to previously used adhesive products. 2. Planned electrical cardioversion, catheter ablation, or surgical treatment for an arrhythmia during the study period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Participants with Clinically Significant Arrhythmia | Visit 3 (approximately 14 [±3] days after device application at Visit 1) | The rate of participants diagnosed with at least one clinically significant arrhythmia will be evaluated based on ECG monitoring. Clinically significant arrhythmias include supraventricular tachycardia (≥3 consecutive beats, excluding atrial fibrillation/flutter), atrial fibrillation/flutter (episode ≥30 seconds), sinus pause (≥3 seconds), second-degree (Mobitz type II) or third-degree atrioventricular block, ventricular tachycardia (≥3 consecutive beats), and polymorphic ventricular tachycardia or ventricular fibrillation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Skin Adverse Events | Visit 3 (approximately 14 [±3] days after device application at Visit 1) | The occurrence, frequency, severity, time of onset, and seriousness of skin adverse events associated with MEMO Patch use will be evaluated. |
| MEMO Patch Satisfaction and Usability Questionnaire Score | Visit 3 (approximately 14 [±3] days after device application at Visit 1) | Participant satisfaction and usability of MEMO Patch will be evaluated using a 12-item questionnaire based on a 5-point Likert scale, with scores ranging from 1 to 5. Higher scores indicate better satisfaction and usability. |
Countries
South Korea
Outcome results
None listed