Evaluation of a Single-lead ECG Patch-based Telemetry System for In-hospital Monitoring

December 1, 2025 updated by: Yonsei University

Investigator-initiated Trial to Evaluate the Performance and Utility of a Single-lead Electrocardiogram Patch-based Telemetry System in Patients Requiring In-hospital Telemetry Electrocardiogram Monitoring During Hospitalization

"This investigator-initiated, prospective, single-center clinical study evaluates the performance and clinical utility of a single-lead electrocardiogram (ECG) patch-based telemetry system for hospitalized patients who require in-hospital telemetry ECG monitoring. The system integrates real-time centralized surveillance (MEMO-Cue) with post-hoc analytic review (MEMO-Care) using ECG signals recorded by the MEMO Patch M, aiming to enable timely recognition of clinically important arrhythmias and to inform treatment decisions under routine inpatient conditions.

Adults (≥19 years) indicated for continuous ECG monitoring during admission are enrolled after written informed consent, with a planned sample size of 100 to yield approximately 90 evaluable participants (10% anticipated dropout). The design does not include randomization or blinding. Study procedures include a screening visit (eligibility and baseline data), an inpatient monitoring period of at least 12 hours and up to 8 days with simultaneous MEMO-Cue monitoring and MEMO Patch M recording, and an end-of-visit assessment when MEMO-Care analytic results become available. Concomitant therapies deemed clinically necessary are permitted and documented, and adverse events are prospectively assessed.

Clinical utility endpoints quantify care impact and timeliness: (1) rate of treatment plan changes (e.g., initiation or modification of anticoagulants or antiarrhythmic drugs, cardioversion scheduling, device implantation, or other actions); (2) time to recognition (days) of major arrhythmias-atrial fibrillation (AF), ventricular tachycardia (VT), pause, ventricular premature complex (VPC), and supraventricular tachycardia (SVT)-based on MEMO-Cue alarms or MEMO-Care results with objective confirmation; (3) reduction ratio in recognition time when identified earlier by MEMO-Cue versus MEMO-Care; and (4) proportion of participants with shortened recognition time by MEMO-Cue.

Clinical performance endpoints assess detection characteristics and agreement between MEMO-Cue alarms and MEMO-Care findings: (1) clinical sensitivity (true positive / [true positive + false negative]); (2) precision, i.e., positive predictive value (true positive / [true positive + false positive]); and (3) positive concordance rate (proportion of MEMO-Care-detected arrhythmias alerted by MEMO-Cue). Safety is captured as treatment-emergent adverse events after device application, including device-related skin reactions, detachment, or signal dropouts, with severity graded per NCI-CTCAE v5.0 and relationship to device recorded.

By characterizing real-time patch-based telemetry alongside analytic review and its influence on diagnostic timing and management, the study aims to generate practical evidence supporting feasibility, reliability, and workflow compatibility of single-lead patch telemetry for in-hospital ECG monitoring.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Korea
      • Seoul, South Korea
        • Yonsei University College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults aged 19 years or older who provide written informed consent for participation.
  • Patients requiring in-hospital telemetry electrocardiogram monitoring during hospitalization.

Exclusion Criteria:

  • Known hypersensitivity or allergic reaction to adhesives or hydrogel.
  • Presence of skin wounds at the intended application site of the investigational device.
  • Implanted cardiac electronic devices such as pacemakers, ICDs, or other CIEDs
  • Current or past history of skin cancer, rash, dermatologic disorders, keloid formation, or skin injury.
  • Any condition judged by the investigator to increase risk or make participation inappropriate.
  • Cognitive impairment that precludes understanding of study information or voluntary consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MEMO-Cue
Participants receive continuous in-hospital ECG monitoring using the MEMO-Cue system, which combines a single-lead patch device with real-time telemetry software. Monitoring lasts 12 hours to 8 days, and arrhythmia detection performance is compared with retrospective analysis using MEMO Care.
Device: MEMO-Cue-based telemetry monitoring
In-hospital telemetry electrocardiogram monitoring using the MEMO-Cue system, which integrates a single-lead patch-type Holter device (MEMO Patch M) with a central monitoring software (MEMO-Cue) and an analysis platform (MEMO Care). Participants requiring continuous ECG telemetry during hospitalization are monitored for at least 12 hours and up to 8 days to evaluate the system's clinical utility and performance in real-time arrhythmia detection compared with retrospective analysis using MEMO Care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical decision change rate based on MEMO-Cue monitoring
Time Frame: From baseline (start of MEMO-Cue monitoring) to end of monitoring period, up to 8 days during hospitalization.
Clinical utility will be evaluated by rate of change in treatment plans (%)
From baseline (start of MEMO-Cue monitoring) to end of monitoring period, up to 8 days during hospitalization.
Clinical decision change rate based on MEMO-Cue monitoring
Time Frame: From baseline (start of MEMO-Cue monitoring) to end of monitoring period, up to 8 days during hospitalization.
Clinical utility will be evaluated by time to recognition of major arrhythmias (days)
From baseline (start of MEMO-Cue monitoring) to end of monitoring period, up to 8 days during hospitalization.
Clinical decision change rate based on MEMO-Cue monitoring
Time Frame: From baseline (start of MEMO-Cue monitoring) to end of monitoring period, up to 8 days during hospitalization.
Clinical utility will be evaluated by reduction rate in arrhythmia recognition time (%)
From baseline (start of MEMO-Cue monitoring) to end of monitoring period, up to 8 days during hospitalization.
Clinical decision change rate based on MEMO-Cue monitoring
Time Frame: From baseline (start of MEMO-Cue monitoring) to end of monitoring period, up to 8 days during hospitalization.
Clinical utility will be evaluated by proportion of participants with shortened recognition time
From baseline (start of MEMO-Cue monitoring) to end of monitoring period, up to 8 days during hospitalization.
Clinical decision change rate based on MEMO-Cue monitoring
Time Frame: From baseline (start of MEMO-Cue monitoring) to end of monitoring period, up to 8 days during hospitalization.
Clinical performance will be assessed by clinical sensitivity (%)
From baseline (start of MEMO-Cue monitoring) to end of monitoring period, up to 8 days during hospitalization.
Clinical decision change rate based on MEMO-Cue monitoring
Time Frame: From baseline (start of MEMO-Cue monitoring) to end of monitoring period, up to 8 days during hospitalization.
Clinical performance will be assessed by precision (%)
From baseline (start of MEMO-Cue monitoring) to end of monitoring period, up to 8 days during hospitalization.
Clinical decision change rate based on MEMO-Cue monitoring
Time Frame: From baseline (start of MEMO-Cue monitoring) to end of monitoring period, up to 8 days during hospitalization.
Clinical performance will be assessed by positive concordance rate (%)
From baseline (start of MEMO-Cue monitoring) to end of monitoring period, up to 8 days during hospitalization.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2025

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

November 14, 2025

First Submitted That Met QC Criteria

December 1, 2025

First Posted (Estimated)

December 3, 2025

Study Record Updates

Last Update Posted (Estimated)

December 3, 2025

Last Update Submitted That Met QC Criteria

December 1, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1-2025-0048

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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