Sorin Group has enrolled the first patient in its ISIS-ICD clinical trial, designed to evaluate the percentage of patients implanted with an implantable cardioverter-defibrillator featuring the Sorin PARAD+ discrimination algorithm who are free from inappropriate shocks over a one-year follow up.
The trial will enrol up to 1,000 patients to compare the percentage of patients free from inappropriate shocks when implanted with dual-chamber implantable cardioverter-defibrillators and cardiac resynchronisation therapy devices from Sorin's PARADYM and PARADYM RF families.
Secondary objectives include investigating the percentage of shocks that are appropriately delivered over the one-year follow up, and assessing the incidence of unscheduled visits, reprogramming and medication changes needed due to inappropriate shocks.
Earlier studies has shown that Sorin's PARAD/PARAD+ discrimination algorithms delivered the lowest rate of inappropriate shocks reported so far in a general implantable cardioverter-defibrillator population.
Sorin Group CRM Business Unit president Stefano Di Lullo said the company's PARADYM and PARADYM RF defibrillators offer accurate, safe therapies, while preserving patients' quality of life, and the ISIS-ICD study will provide physicians valuable data on the efficacy of the PARAD+ algorithm.