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NCT07725445

Overview

NCT ID: NCT07725445
Lead Sponsor: HUINNO Co., LtdINDUSTRY
Official Title: Evaluation the Lightweight ECG Monitoring System Based on Al as a Telemetry ECG Monitoring System
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

Status and Timeline

Status: Completed
Last Update Posted: Jul 30, 2026Actual
Start Date: Sep 28, 2022Actual
Primary Completion Date: Nov 30, 2023Actual
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: 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.

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 18Actual
Primary Purpose: Diagnostic
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

Contacts and Locations

Central Contacts: No data available
Locations: Korea University Anam Hospital

Similar Studies

Participant Group/Arms

Remote MEMO Patch Plus MonitoringExperimental

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