Evaluation of an AI-Based Lightweight ECG Telemetry Monitoring System
29 juli 2026 uppdaterad av: HUINNO Co., Ltd
Evaluation the Lightweight ECG Monitoring System Based on Al as a Telemetry ECG Monitoring System
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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
18
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
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Seoul, Sydkorea
- Korea University Anam Hospital
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Diagnostisk
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: Remote MEMO Patch Plus Monitoring
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.
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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.
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Real-time ECG Transmission Rate
Tidsram: During continuous ECG monitoring (minimum 48 hours to maximum 168 hours)
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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.
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During continuous ECG monitoring (minimum 48 hours to maximum 168 hours)
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Arrhythmia Detection Rate
Tidsram: End-of-study visit (7 to 30 days after hospital discharge)
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The arrhythmia detection rate of the MEMO Patch Plus will be evaluated during the monitoring period based on clinically identified arrhythmia events.
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End-of-study visit (7 to 30 days after hospital discharge)
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Device Usability Questionnaire Score
Tidsram: Visit 3 (48 to 168 hours after device application)
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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.
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Visit 3 (48 to 168 hours after device application)
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
28 september 2022
Primärt slutförande (Faktisk)
30 november 2023
Avslutad studie (Faktisk)
30 november 2023
Studieregistreringsdatum
Först inskickad
21 juli 2026
Först inskickad som uppfyllde QC-kriterierna
21 juli 2026
Första postat (Faktisk)
24 juli 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
30 juli 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
29 juli 2026
Senast verifierad
1 juli 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- S1MP1-TM
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
IPD-planbeskrivning
Individual participant data collected in this study are not planned to be shared with external researchers.
Any future sharing would require separate sponsor approval and compliance with applicable privacy, ethical, and institutional requirements.
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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