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"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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MEMO-Cue | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MEMO-Cue-based telemetry monitoring | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical decision change rate based on MEMO-Cue monitoring | 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 | 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 | 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 | 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 | 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 | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yonsei University College of Medicine | Seoul | South Korea |
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|
| Clinical decision change rate based on MEMO-Cue monitoring | 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. |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D001281 | Atrial Fibrillation |
| D017180 | Tachycardia, Ventricular |
| D013617 | Tachycardia, Supraventricular |
| D001919 | Bradycardia |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013610 | Tachycardia |
| D000075224 | Cardiac Conduction System Disease |
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