The primary goal of long term monitoring is the Improvement of diagnostic yield. Despite the clear utility of Holter monitoring in clinical cardiology, issues of relatively low diagnostic yield, cost and inconvenience have motivated the development of ultra-portable devices referred to as ECG patch monitors. Although the 'gold standard' for assessing cardiac rhythm abnormalities remains a 12-lead Holter, there is an increasing need to develop miniaturized portable monitoring devices for long term evaluation of cardiac rhythm in real-world environments such as the workplace or home. We have designed a novel ECG patch monitor called a Universal ECG Sensor (UES) for very long term monitoring of cardiac arrhythmic events. UES features 12-lead recording capability and real-time telemetry. To facilitate patient acceptance, UES underwent a radical miniaturization and redesign to include wireless communication, water proofing and a patch carrier for attaching devices directly to the patient's skin. The main objective of the proposed research is to validate clinical utility f this new device through a mini-trial by comparing UES to a standard 12-lead Holter. The primary outcome was defined as Arrhythmic event detection yield by UES as compared to the traditional ambulatory Holter monitor. The secondary outcome is centered on subjects' tolerance for wearing the UES as compared to the traditional ambulatory Holter monitor.
Thesaurus Terms: Adhesives;Ambulatory Monitoring;Arrhythmia;Bathing;Cardiac;Cardiology;Clinical;Clinical Trials;Communication;Cost;Cost Effective;Data Exchange;Design;Detection;Development;Devices;Diagnostic;Electrocardiogram;Electrodes;Enrollment;Environment;Evaluation;Event;Fiber;Flexibility;Goals;Gold;Heart Rhythm;Holter Electrocardiography;Home Environment;Hospitals;Hour;Lead;Life;Link;Location;Marketing;Miniaturization;Miniaturize;Monitor;Monitoring Device;National Center For Health Statistics (U.S.);Novel;Patients;Pharmaceutical Preparations;Phase;Primary Outcome;Procedures;Process;Public Health Relevance;Research;Research Study;Resolution;Safety Study;Secondary Outcome;Sensitivity And Specificity;Sensor;Silver;Silver Chloride;Skin;System;Technology;Telemetry;Testing;Time;Trial Comparing;Water;Wireless Technology;Workplace;
