BIOTRONIK Lumax DR ICD Series, Technical Manual, Page: 54 / 176

46 Lumax Technical Manual
7. The purpose of Secondary Endpoint 7 is to evaluate the
observation rate. Observations are defined as clinical events
that do not require additional invasive intervention to resolve.
For the study group, there were 210 observations in 104
patients with cumulative implant duration of 1240.4 months
(101.9 patient years). 78.2% of the enrolled study patients
have a reported observation. The rate of observations per
patient-year is 2.06. For the control group, there were 81
observations in 44 patients with cumulative implant duration
of 596.5 months (49.0 patient years). 65.7% of the enrolled
control patients had a reported observation. The rate of
observations per patient-year was 1.65.
8. The purpose of Secondary Endpoint 8 is to evaluate peak
VO2 as a measure of effectiveness of the Tupos LV/ATx
system in providing CRT. The core lab was blinded to study
randomization assignments during evaluation of the results of
the cardiopulmonary exercise (CPX) testing in order to
minimize the potential for bias. According to the protocol, to
be included in the analysis, patients were required to attain a
respiratory exchange ratio (RER) of
≥
1.
Table 17 provides a summary of peak VO
2
results for 42
patients with CPX testing completed at Baseline and the Six-
Month follow-up and with an RER of
≥
1.