Evaluation of an AI-Based Lightweight ECG Telemetry Monitoring System
29 juli 2026 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
18
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Seoul, Zuid -Korea
- Korea University Anam Hospital
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Diagnostisch
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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.
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Real-time ECG Transmission Rate
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Arrhythmia Detection Rate
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
28 september 2022
Primaire voltooiing (Werkelijk)
30 november 2023
Studie voltooiing (Werkelijk)
30 november 2023
Studieregistratiedata
Eerst ingediend
21 juli 2026
Eerst ingediend dat voldeed aan de QC-criteria
21 juli 2026
Eerst geplaatst (Werkelijk)
24 juli 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
30 juli 2026
Laatste update ingediend die voldeed aan QC-criteria
29 juli 2026
Laatst geverifieerd
1 juli 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- S1MP1-TM
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Beschrijving IPD-plan
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.
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .