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

Official title

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

Overview

"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.

Interventions

• 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 Car

Primary outcome measures

• 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 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 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 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 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 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 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.]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Single group

Masking

Open label

Primary purpose

Diagnostic

Study locations

South Korea · 1 center

• Yonsei University College of Medicine — Seoul

Identifiers

NCT: NCT07260721 · 1-2025-0048

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗