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.