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

NCT ID: NCT07260721

Last Updated: 2025-12-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-31
• Study Completion Date: 2026-09-30

Brief Summary

"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.

Conditions

Arrhythmias; Atrial Fibrillation; Ventricular Tachycardia; Supraventricular Tachycardia; Bradycardia; Telemetry; Patient Monitoring; Hospitalization

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

MEMO-Cue-based telemetry monitoring

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Yonsei University College of Medicine

Seoul, , South Korea

Countries

South Korea

Other Identifiers

1-2025-0048

Identifier Type: -

Identifier Source: org_study_id