Sorin Group has enrolled the first patient in its ISIS-ICD clinical trial. The primary objective of the study is to evaluate the percentage of patients implanted with an implantable cardioverter-defibrillator (ICD), featuring the Sorin PARAD discrimination algorithm, that are free from inappropriate ICD shocks over a one-year follow-up. The first patient was enrolled by Mark Richards at The Toledo Hospital in Toledo, Ohio, USA.
“According to published literature, approximately 11–17% of ICD patients receive inappropriate shocks within one year after implant, negatively impacting patients’ health and quality of life,” said Richards, primary investigator for the ISIS-ICD study in the United States. “ICD shocks are painful and have been shown to increase anxiety and depression. In rare instances, they can also cause more dangerous arrhythmias. We expect the PARAD+ algorithm will markedly reduce the inappropriate shock rate by ensuring only harmful ventricular arrhythmias are treated. We are optimistic the ISIS-ICD trial will demonstrate this improved performance.”
Measures to minimise the frequency of inappropriate shocks are important because they are painful, psychologically disturbing and potentially arrhythmogenic. The Sorin families of PARADYM and PARADYM RF defibrillators incorporate anti-shock features. A previous study has shown that Sorin’s PARAD/PARAD+ discrimination algorithms delivered the lowest rate of inappropriate shocks reported thus far, in a general ICD population.
This multi-year, prospective trial will compare to historical controls from major ICD studies, specifically the per cent of patients free from inappropriate shocks when implanted with Sorin’s PARADYMTM and PARADYM RF families of dual-chamber ICDs and cardiac resynchronisation therapy devices (CRT-D). The study will enrol up to 1,000 patients worldwide.
Secondary objectives of this study include evaluating the percentage of shocks that are appropriately delivered over the one-year follow up, and assessing the incidence of unscheduled visits, reprogramming and medication change needs due to inappropriate shocks over that year.
“We are committed to patient-centric innovation, and our PARADYM and PARADYM RF defibrillators offer accurate, safe therapies, while preserving patients’ quality of life,” said Stefano Di Lullo, Sorin Group’s president of the CRM Business Unit.”We are confident that the ISIS-ICD study will provide physicians valuable data on the efficacy of our PARAD+ algorithm.”