Sorin Group, a developer of cardiovascular defibrillators, has enrolled first patient for its ISIS-ICD clinical study.
This multi-year, prospective trial is designed to examine patients free from inappropriate shocks when implanted with its PARADYM and PARADYM RF3 families of dual-chamber implantable cardioverter-defibrillators (ICD) and cardiac resynchronization therapy devices (CRT-D).
The company said it will enroll up to 1,000 patients from many US sites.
The primary objective of the study is to assess percentage of ICDs implanted patients free from ICD shocks over a one-year follow up.
The Secondary objectives aim to assess 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.
Sorin GroupCRM Business Unit president Stefano Di Lullo said their PARADYM and PARADYM RF defibrillators offer safe therapies, while preserving patients’ quality of life.
"We are confident that the ISIS-ICD study will provide physicians valuable data on the efficacy of our PARAD+ algorithm," Lullo said.