Evaluation of an AI-Based Lightweight ECG Telemetry Monitoring System

HUINNO Co., Ltd18 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Heart Diseases Cardiac Surgery Cardiac Arrhythmias

Interventions

MEMO PatchDEVICE

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.

Eligibility

Sex: ALLMin age: 19 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Korea University Anam Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Real-time ECG Transmission Rate

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.

Time frame: During continuous ECG monitoring (minimum 48 hours to maximum 168 hours)

Secondary Outcomes

Arrhythmia Detection Rate

The arrhythmia detection rate of the MEMO Patch Plus will be evaluated during the monitoring period based on clinically identified arrhythmia events.

Time frame: End-of-study visit (7 to 30 days after hospital discharge)

Device Usability Questionnaire Score

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.

Time frame: Visit 3 (48 to 168 hours after device application)

Data from ClinicalTrials.gov

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