Design of a Test Protocol for Implantable Defibrillators

Electrical management of potentially lethal arrhythmias has been found to dramatically improve survcandidates at risk of sudden cardiac death. Over 40,000 Implantable cardioverter/defibrillators (ICDsince initial FDA approval in 1985. False positive delivery of shock remains a major problem and newdesigned with more sophisticated arrhythmia detection schemes and tiered-therapy protocols. We willstandardize testing and device evaluation for future devices. Such a system will assess sensitivityalgorithms and device response to yield reliable statistics on safety and efficacy. In Phase l we wifeasibility of designing a tandardized test for exercising the arrhythmia detection mechanisms contvariety of both simulated and clinical experimental data. We will 1) complete the development of a catrial and ventricular events which can mimic any cardiac arrhythmia, and determine device response;proprietary test set of clinical data previously recorded during electrophysiology studies, as a comtraining set which has been made available by us to commercial designers of implantable devices; andprotocol utilizing both simulated and experimental signals for evaluation of next-generation devicecategories as oversensing, undersensing, errors in rhythm diagnosis, errors in pacing therapy and/or