Lumax Family of ICDs and CRTâDs - BIOTRONIK USA - News
Lumax Family of ICDs and CRTâDs - BIOTRONIK USA - News
Lumax Family of ICDs and CRTâDs - BIOTRONIK USA - News
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32 <strong>Lumax</strong> <strong>Family</strong> Technical Manual<br />
Overall Results<br />
• There were 192 endocardial <strong>and</strong> 19 epicardial leads implanted in<br />
193 patients. Investigators were allowed to choose among any legally<br />
marketed LV lead according to familiarity with the lead <strong>and</strong> patient<br />
anatomy. The Tupos LV⁄ATx CRT‐D was implanted with 7 endocardial<br />
<strong>and</strong> 4 epicardial lead models from 6 different manufacturers. There<br />
were no adverse events reported attributable to lead‐generator<br />
incompatibility.<br />
• The cumulative implant duration was 1240.4 months with a mean<br />
duration <strong>of</strong> 9.6 months for the study group. The cumulative implant<br />
duration is 596.5 months with a mean duration <strong>of</strong> 9.3 months for the<br />
control group.<br />
• For the study group, there have been 278 adverse events<br />
(210 observations in 104 patients <strong>and</strong> 68 complications in<br />
50 patients). There has been one unanticipated adverse device effect<br />
reported.<br />
• For the control group, there have been 105 adverse events<br />
(81 observations in 44 patients <strong>and</strong> 24 complications in 19 patients).<br />
There have been no unanticipated adverse device effects reported.<br />
• There have been 10 patient deaths reported in the study group<br />
<strong>and</strong> 4 patient deaths reported in the control group. The clinical<br />
investigators have determined that no deaths were related to the<br />
study device.<br />
1.6.2.4 Primary Endpoint 1: Six Minute Walk Test & QOL<br />
(Effectiveness)<br />
The purpose <strong>of</strong> Primary Endpoint 1 is to evaluate the effectiveness <strong>of</strong><br />
the Tupos LV⁄ATx system in providing CRT as measured by the average<br />
composite rate <strong>of</strong> improvement in six minute walk test <strong>and</strong> QOL.<br />
Table 8 presents the average composite rate <strong>of</strong> improvement in six<br />
minute walk test distance <strong>and</strong> QOL score, the average 6‐minute<br />
walk test distance <strong>and</strong> the average QOL score at Baseline <strong>and</strong> at the<br />
Six‐Month follow‐up, as well as the average difference in 6‐minute<br />
walk test distance <strong>and</strong> QOL score between Baseline <strong>and</strong> the Six‐Month<br />
follow‐up for the Study <strong>and</strong> Control Groups for those patients with six<br />
minute walk test data <strong>and</strong> complete QOL data at both Baseline <strong>and</strong> the<br />
Six‐Month follow‐up.
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