Cardiac Arrhythmias, Cardiac Surgery, Heart Diseases
Conditions
Keywords
MEMO Patch Plus, Telemetry Electrocardiography, Remote ECG Monitoring, Wearable ECG, Arrhythmia Detection, Cardiac Surgery, Cardiac Telemetry
Brief summary
This study aims to evaluate the clinical applicability of the AI-based lightweight ECG monitoring system (MEMO Patch Plus) as a telemetry ECG monitoring system in patients undergoing cardiac surgery. Participants will wear the MEMO Patch Plus for at least 48 hours and up to 168 hours after transfer from the intensive care unit to the general ward. The study will evaluate real-time ECG transmission, arrhythmia detection, device usability, and safety to generate preliminary evidence supporting future clinical studies.
Detailed description
Participants who provide written informed consent and meet all eligibility criteria will be enrolled in this prospective, single-arm study. After transfer from the intensive care unit to the general ward, participants will wear the MEMO Patch Plus for continuous electrocardiographic (ECG) monitoring for a minimum of 48 hours and up to 168 hours. During the study period, the MEMO Patch Plus will continuously transmit ECG data to the monitoring system, allowing real-time remote monitoring by healthcare professionals. Clinical information related to arrhythmia detection, ECG transmission performance, and device operation will be collected throughout the monitoring period. The primary outcome is the real-time ECG transmission rate. Secondary outcomes include the arrhythmia detection rate, device usability assessed by participants using a questionnaire, and safety assessed by device-related adverse events, including skin irritation. The results of this exploratory study will be used to evaluate the clinical applicability of the MEMO Patch Plus as a telemetry ECG monitoring system and to provide preliminary evidence for future clinical studies.
Interventions
DEVICEMEMO Patch
The MEMO Patch Plus is a wearable adhesive ECG monitoring device for continuous cardiac rhythm monitoring. The device continuously acquires single-channel ECG signals and wirelessly transmits the data to a remote monitoring system, enabling real-time ECG monitoring and arrhythmia detection by healthcare professionals. The device is intended for continuous cardiac rhythm monitoring in hospitalized patients.
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 who meet the eligibility criteria will wear the MEMO Patch Plus after transfer from the intensive care unit to the general ward. The device will be used for continuous electrocardiographic (ECG) monitoring for a minimum of 48 hours and up to 168 hours. During the monitoring period, ECG data will be transmitted in real time to the monitoring system for remote observation. The study will evaluate the real-time ECG transmission rate, arrhythmia detection rate, device usability assessed by participants, and device-related safety to assess the clinical applicability of the MEMO Patch Plus as a telemetry ECG monitoring system.
Eligibility
Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients undergoing cardiac surgery for cardiac diseases, including aortic valve stenosis, pulmonary valve regurgitation, mitral valve stenosis, mitral valve regurgitation, acute myocardial infarction, unstable angina, stable angina, aortic aneurysm, aortic dissection, atrial septal defect, cardiac tumor, and atrial fibrillation * Patients who voluntarily decide to participate in this clinical study and provide written informed consent
Exclusion criteria
* Patients younger than 19 years of age or 80 years of age or older * Pregnant or lactating women * Patients whom the investigator judges to be unsuitable for participation in this clinical study or whose participation may increase the risk to the patient * Patients with sensitive skin, an allergic reaction to silicone, or skin rash at the intended device application site * Patients who, due to cognitive vulnerability, are judged to be unable to understand the information related to the study, appreciate its significance, and make an independent voluntary decision regarding participation Hemodynamically unstable patients, including those receiving extracorporeal membrane oxygenation (ECMO) or high-dose inotropic support (e.g., epinephrine) * Patients whom the investigator considers inappropriate for participation in this clinical study for ethical reasons or because participation may affect the study results. Specific reasons will be documented in the source records.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Real-time ECG Transmission Rate | During continuous ECG monitoring (minimum 48 hours to maximum 168 hours) | The real-time ECG transmission rate of the MEMO Patch Plus will be evaluated during the monitoring period. The transmission rate is defined as the proportion of successfully transmitted ECG data relative to the total monitoring time. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Arrhythmia Detection Rate | End-of-study visit (7 to 30 days after hospital discharge) | The arrhythmia detection rate of the MEMO Patch Plus will be evaluated during the monitoring period based on clinically identified arrhythmia events. |
| Device Usability Questionnaire Score | Visit 3 (48 to 168 hours after device application) | Device usability will be evaluated using a participant-completed usability questionnaire after completion of the monitoring period. The questionnaire uses a 5-point Likert scale, with scores ranging from 1 to 5. Higher scores indicate better device usability. |
Countries
South Korea
Outcome results
None listed