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56 Stratos LV/LV-T Technical Manual
• There were 192 endocardial and 19 epicardial leads
implanted in 193 patients. Investigators were allowed to
choose among any legally marketed LV lead according
to their familiarity with the lead and patient anatomy. The
Tupos LV/ATx CRT-D was implanted with 7 endocardial
and 4 epicardial lead models from 6 different
manufacturers. There were no adverse events reported
attributable to lead-generator incompatibility.
• The cumulative implant duration is 1240.4 months with a
mean duration of 9.6 months for the study group. The
cumulative implant duration is 596.5 months with a
mean duration of 9.3 months for the control group.
• The overall protocol compliance rate is 79.2% in the
study group and 85.9% in the control group. The overall
follow-up compliance rate is 99.4% in the study group
and 98.3% in the control group.
• 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.
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 15
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.