The study is expected to help in prevention of sudden cardiac death where the patient suffers from severely reduced cardiac function (left ventricular ejection fraction </= 35 percent).
Boston Scientific claims that primary prevention patients do not have a history of life-threatening arrhythmic event but they stand a chance of having sudden cardiac arrest, which leads to death.
The group patient group represents the highest number of individuals in the US and Europe who have transvenous ICD (TV-ICDs) devices implanted.
The UNTOUCHED study will compare outcomes during an 18-month follow-up period to objective performance criteria that is found out through the Multicenter Automatic Defibrillator Implantation Trial-Reduce Inappropriate Therapy (MADIT-RIT) study.
MADIT-RIT evaluated shock rates in 1500 patients who had got TV-ICD devices implanted
St. Antonius Hospital EU principal investigator Dr Lucas Boersma said: "The MADIT-RIT trial demonstrated that standardized 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 standardized therapy settings similar to MADIT-RIT."
Boston Scientific’s S-ICD System has already been approved by the FDA and has stated selling in Europe and has been rolled out in the US.
