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Completed
NCT07725445
Evaluation of an AI-Based Lightweight ECG Telemetry Monitoring System
Conditions: Heart Diseases, Cardiac Surgery, Cardiac Arrhythmias
Sex: All
Ages: 19 Years – 80 Years
Healthy volunteers: No
Phase: NA
Enrollment: 18
Sponsor: HUINNO Co., Ltd
Location: Korea University Anam Hospital Seoul
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.
Eligibility Criteria
Inclusion Criteria:
* Participants must meet all of the following criteria:
1. 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.
2. Patients who voluntarily decide to participate in this clinical study and provide written informed consent.
Exclusion Criteria:
* Participants meeting any of the following criteria will be excluded:
1. Patients younger than 19 years of age or 80 years of age or older.
2. Pregnant or lactating women.
3. Patients whom the investigator judges to be unsuitable for participation in this clinical study or whose participation may increase the risk to the patient.
4. Patients with sensitive skin, an allergic reaction to silicone, or skin rash at the intended device application site.
P5. atients 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.
H6. emodynamically unstable patients, including those receiving extracorporeal membrane oxygenation (ECMO) or high-dose inotropic support (e.g., epinephrine).
7\. 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.
Source: ClinicalTrials.gov (NCT07725445). StuddyBuddy aggregates publicly available trial information.