In-silico pre-clinical trials for implantable cardioverter defibrillators

摘要: Regulatory authorities require that the safety and efficacy of a new high-risk medical device be proven in Clinical Trial (CT), which effects on group patients are compared to current standard care. Phase III trials can run for several years, cost millions dollars, expose an unproven device. In this paper, we demonstrate how use large synthetic based computer modeling improve planning CT so as increase chances successful trial implantable cardioverter defibrillators (ICDs). We developed model electrical generation propagation heart. This was used generate heart instances capable producing episodes 19 different arrhythmias. also implemented two arrhythmia detection algorithms from literature: Rhythm ID Boston Scientific PR Logic + Wavelet Medtronic. Using setup, conducted multiple in-silico compare ability appropriately discriminate between potentially fatal Ventricular Tachy-arrhythmias (VT) nonfatal Supra-Ventricular (SVTs). The results our indicate less able SVT VT may lead more cases inappropriate therapy. corroborates findings Going Head (RIGHT), clinical patients. further demonstrated result continues hold if vary distribution arrhythmias population. same cohort explore sensitivity outcome parameter settings algorithms, is not feasible real trial. In-silico provide early insight into factors affect at fraction duration without ethical issues.