Evaluation of an AI-Based Lightweight ECG Telemetry Monitoring System

NCT07725445 | Completed

• 1 other identifier: S1MP1-TM
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Diseases; Cardiac Surgery; Cardiac Arrhythmias

Keywords

MEMO Patch Plus; Telemetry Electrocardiography; Remote ECG Monitoring; Wearable ECG; Arrhythmia Detection; Cardiac Surgery; Cardiac Telemetry

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (2)

• Arrhythmia Detection Rate

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

• Device Usability Questionnaire Score

  Visit 3 (48 to 168 hours after device application)

Study Arms (1)

Remote MEMO Patch Plus Monitoring

EXPERIMENTAL

Participants wear the MEMO Patch Plus after transfer from the intensive care unit to the general ward for continuous telemetry electrocardiographic (ECG) monitoring. The device is worn for a minimum of 48 hours and up to 168 hours, during which ECG data are continuously transmitted to the monitoring system for real-time remote monitoring. The study evaluates the clinical applicability of the MEMO Patch Plus by assessing the real-time ECG transmission rate, arrhythmia detection rate, participant-reported device usability, and device-related safety.

Device: MEMO Patch

Interventions

MEMO Patch DEVICE

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.

Also known as: Adhesive ECG Patch

Remote MEMO Patch Plus Monitoring

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• HUINNO Co., Ltd: lead

Study Sites (1)

Korea University Anam Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Heart Diseases; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No masking was applied to participants or investigators.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 21, 2026
• First Posted: July 24, 2026
• Study Start: September 28, 2022
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: July 30, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)