High-level modeling for computer-aided clinical trials of medical devices

摘要: Medical devices like the Implantable Cardioverter Defibrillator (ICD) are life-critical systems. Malfunctions of device can cause serious injury or death patient. In addition to rigorous testing and verification during development process, new medical often go through clinical trials evaluate their safety performance on sample populations. Clinical costly prone failure if not planned executed properly. Evaluating computer models relevant physiological systems provide helpful insights into efficacy device, thus helping plan execute a trial. this paper, we demonstrate how develop high-level cardiac electrophysiology apply them Rhythm ID Head Trial (RIGHT), 5-year long trial for comparing two ICDs. We refer as Computer-Aided (CACT). explored modeling options, white-box model capturing mechanisms behaviors, blackbox which uses machine learning methods synthesize input signals. Both were able generate inputs ICDs discuss challenges appropriateness options.