User Manual

48 Lumax Technical Manual
The gender distribution in this clinical investigation is consistent
within the study groups and includes a representative proportion
of female participants. There were no significant differences in
any of the primary or secondary endpoints between the male and
female population.
1.6.2.12 Conclusions
The IDE Clinical
study (OPTION LV/ATx) demonstrated that the
safety and effectiveness of the Tupos LV/ATx CRT-D device is
equivalent to that of similar legally marketed CRT-D devices.
Although the study missed its primary safety endpoint, additional
post hoc analyses were conducted to reassure that the safety
profile of the device is comparable to other legally marketed
CRT-D devices.
1.6.3 Lumax HF-T V-V Clinical Study
1.6.3.1 Study Overview
The Lumax HF-T V-V clinical study is a randomized, double-
blinded, crossover, multi-center, prospective trial. The purpose of
the study is to assess the safety and efficacy of adding
programmable V-V delay biventricular pacing when used as part
of echo optimization of V-V timing (OPT). The assessment
consisted of comparing one-month periods of CRT with (OPT)
and without (SIM) V-V programmability and optimization in the
same patients to assess whether a statistically significant
increase of worsened HF status occurred during V-V adjustment.
The V-V delay feature is programmed to provide CRT through the
selection of the first chamber paced and adjustment of the V-V
delay. When V-V delay programmability is not available, CRT
provides simultaneous biventricular pacing (V-V delay is 0 ms).