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.
The US market for ECG procedures, electrodes, lead wires and patient cables is estimated to be around 1 billion dollars [1] (National Center for Health Statistics) per year and growing at a rate of 16% per year. An important component of this market is ECG monitoring performed in both hospitals CCU/ICU and ambulatory settings. We propose to conduct a research study to validate novel Universal ECG Sensor (UES) technology that will ultimately result in more diagnostically accurate and cost effective ECG sensors for routine and long term monitoring.
