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Evaluation of an AI-Based Lightweight ECG Telemetry Monitoring System

21. juli 2026 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

18

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Sydkorea
      • Seoul, Sydkorea
        • Korea University Anam Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Diagnostisk
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Enhed: MEMO Patch
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.
Andre navne:
  • Adhesive ECG Patch

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Real-time ECG Transmission Rate
Tidsramme: During continuous ECG monitoring (minimum 48 hours to maximum 168 hours)
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)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Arrhythmia Detection Rate
Tidsramme: End-of-study visit (7 to 30 days after hospital discharge)
The arrhythmia detection rate of the MEMO Patch Plus will be evaluated during the monitoring period based on clinically identified arrhythmia events.
End-of-study visit (7 to 30 days after hospital discharge)
Device Usability
Tidsramme: Visit 3 (48 to 168 hours after device application)
Device usability will be evaluated using a participant-completed usability questionnaire after completion of the monitoring period.
Visit 3 (48 to 168 hours after device application)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

HUINNO Co., Ltd

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

28. september 2022

Primær færdiggørelse (Faktiske)

30. november 2023

Studieafslutning (Faktiske)

30. november 2023

Datoer for studieregistrering

Først indsendt

21. juli 2026

Først indsendt, der opfyldte QC-kriterier

21. juli 2026

Først opslået (Faktiske)

24. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

24. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • S1MP1-TM

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Hjertesygdomme

Kliniske forsøg med MEMO Patch

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Ireland

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner