Boston Scientific has started a global study to validate the rate and causes of shocks in patients implanted with the EMBLEM subcutaneous implantable defibrillator (S-ICD) for primary prevention of sudden cardiac death in the setting of severely reduced cardiac function.
Primary prevention patients are at risk of sudden cardiac death, despite lacking a previously documented life-threatening arrhythmic event, and are indicated to receive an implantable defibrillator.
Featuring a minimum of 2,015 patients at up to 200 sites worldwide, the Untouched study will compare outcomes during an 18-month follow-up period to objective performance criteria derived from the multi-centre automatic defibrillator implantation trial-reduce inappropriate therapy (MADIT-RIT) study.
Having evaluated shock rates in 1,500 patients implanted with TV-ICD devices, the MADIT-RIT study is claimed to be one of the largest randomised trials to assess shock reduction strategies for TV-ICD devices.
Netherlands-based St Antonius Hospital EU principal investigator Dr Lucas Boersma said: "The MADIT-RIT trial demonstrated that standardised programming using higher rate cutoffs and longer delays to therapy reduces the incidence of inappropriate shocks for TV-ICDs.
"The Untouched trial will examine the incidence of all-cause shocks when using the EMBLEM S-ICD system with standardised therapy settings similar to MADIT-RIT."
Medical University of South Carolina medicine professor Michael Assey and principal investigator Michael Gold said: "In the published data to date, we have observed S-ICD devices demonstrate comparable inappropriate shock rates for arrhythmias to TV-ICDs.
"Ideally, this trial will demonstrate S-ICD devices can either meet or improve upon the inappropriate shock rates experiences with TV-ICDs in MADIT-RIT within this large patient population."
The first patient enrolled in the global, multi-site, prospective, non-randomised study received an EMBLEM S-ICD system implant at Russells Hall Hospital in Dudley, UK. Enrolments are set to officially start in the US later in 2015.
A next-generation of the Boston Scientific S-ICD system, the EMBLEM S-ICD system received CE Mark earlier in 2015 and was approved by US Food and Drug Administration in March.
Launched in Europe in May, the system became commercially available in the US earlier in June, in preparation for a planned nationwide launch during the third quarter of 2015.
Image: S-ICD system implant in body. Photo: courtesy of Boston Scientific Corporation / affiliates.