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

Официальное название

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

Обзор

"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.

Вмешательства

• Устройство 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

Первичные конечные точки

• Clinical decision change rate based on MEMO-Cue monitoring [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: From baseline (start of MEMO-Cue monitoring) to end of monitoring period, up to 8 days during hospitalization.]

Критерии участия

Критерии включения

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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

South Korea · 1 центр

• Yonsei University College of Medicine — Seoul

Идентификаторы

NCT: NCT07260721 · 1-2025-0048

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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