2.5 Endpoints
Endpoints were assessed from the time of randomization (in the new programming group) through the end of the study (January 2020). Patients were censured if programming zones were changed. In the historical group, endpoints were assessed during an equivalent period of time, until January 2017.
The primary endpoint was any therapy [shock or anti-tachycardia pacing (ATP)] delivered by the defibrillator. Secondary endpoints were appropriate shocks, appropriate ATP, appropriate therapies, inappropriate shocks, syncope, sudden death, cardiovascular death and all-cause death.
ATP and shocks were reviewed by at least two qualified physicians of the study personnel. Syncope was defined as a transient loss of consciousness due to cerebral hypoperfusion, characterized by a rapid onset, short duration, and spontaneous complete recover. Sudden death was considered when an unexpected death occurred in a short period with no discernible cause.