[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"telemetry\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:telemetry":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":5},"100612987","evaluation-of-a-single-lead-ecg-patch-based-telemetry-system-for-in-hospital-monitoring-100612987",false,"NCT07260721","Evaluation of a Single-lead ECG Patch-based Telemetry System for In-hospital Monitoring","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","Inclusion Criteria:\n\n* Adults aged 19 years or older who provide written informed consent for participation.\n* Patients requiring in-hospital telemetry electrocardiogram monitoring during hospitalization.\n\nExclusion Criteria:\n\n* Known hypersensitivity or allergic reaction to adhesives or hydrogel.\n* Presence of skin wounds at the intended application site of the investigational device.\n* Implanted cardiac electronic devices such as pacemakers, ICDs, or other CIEDs\n* Current or past history of skin cancer, rash, dermatologic disorders, keloid formation, or skin injury.\n* Any condition judged by the investigator to increase risk or make participation inappropriate.\n* Cognitive impairment that precludes understanding of study information or voluntary consent.","ALL","19 Years",{"count":19,"type":20},100,"ESTIMATED","INTERVENTIONAL",[23],"NA","\"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.\n\nAdults (≥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.\n\nClinical 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.\n\nClinical performance endpoints assess detection characteristics and agreement between MEMO-Cue alarms and MEMO-Care findings: (1) clinical sensitivity (true positive \u002F \\[true positive + false negative\\]); (2) precision, i.e., positive predictive value (true positive \u002F \\[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.\n\nBy 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.",[26,27,28,29,30,31,32,33],"Arrhythmias","Atrial Fibrillation","Ventricular Tachycardia","Supraventricular Tachycardia","Bradycardia","Telemetry","Patient Monitoring","Hospitalization","NOT_YET_RECRUITING","2025-12-01",{"date":37,"type":38},"2025-12-03","ACTUAL",{"date":40,"type":20},"2025-12",{"date":42,"type":20},"2026-09",{"name":44,"class":45},"Yonsei University","OTHER"]