BIOTRONIK Lumax DR ICD Series, Technical Manual, Page: 42 / 176

34 Lumax Technical Manual
•
For the study group, there have been 278 adverse events
(210 observations in 104 patients and 68 complications in
50 patients). There has been one unanticipated adverse
device effect reported.
•
For the control group, there have been 105 adverse
events (81 observations in 44 patients and 24
complications in 19 patients). There have been no
unanticipated adverse device effects reported.
•
There have been 10 patient deaths reported in the study
group and 4 patient deaths reported in the control group.
The clinical investigators have determined that no deaths
were related to the study device.
1.6.2.4 Primary Endpoint 1: Six Minute Walk Test & QOL
(Effectiveness)
The purpose of Primary Endpoint 1 is to evaluate the
effectiveness of the Tupos LV/ATx system in providing CRT as
measured by the average composite rate of improvement in six
minute walk test and QOL.
Table 7 presents the average composite rate of improvement in
six minute walk test distance and QOL score, the average 6-
minute walk test distance and the average QOL score at Baseline
and at the Six-Month follow-up, as well as the average difference
in 6-minute walk test distance and QOL score between Baseline
and the Six-Month follow-up for the Study and Control Groups for
those patients with six minute walk test data and complete QOL
data at both Baseline and the Six-Month follow-up.