Electrical management of potentially lethal arrhythmias has been found to dramatically improve survival rates in candidates at risk of sudden cardiac death. Over 40,000 Implantable cardioverter/defibrillators (ICDs) have been implanted since initial FDA approval in 1985. False positive delivery of shock remains a major problem and newer devices are being designed with more sophisticated arrhythmia detection schemes and tiered-therapy protocols. We will develop a system to standardize testing and device evaluation for future devices. Such a system will assess sensitivity and specificity of detection algorithms and device response to yield reliable statistics on safety and efficacy.In Phase I we will demonstrate the feasibility of designing a standardized test for exercising the arrhythmia detection mechanisms contained within ICDs on a variety of both simulated and clinical experimental data. We will 1) complete the development of a cardiac simulator of atrial and ventricular events which can mimic any cardiac arrhythmia, and determine device response; 2) create a proprietary test set of clinical data previously recorded during electrophysiology studies, as a companion to an existing training set which has been made available by us to commercial designers of implantable devices; and 3) design a test protocol utilizing both simulated and experimental signals for evaluation of next-generation device performance in such categories as oversensing, undersensing, errors in rhythm diagnosis, errors in pacing therapy and/or shock delivery.National Heart, Lung, and Blood Institute (NHLBI)
