BIOTRONIK Evia DR, Technical Manual

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Evia Technical Manual 47
Clinical Events Committee
The Clinical Events Committee (CEC) is an advisory review
board comprised of three physicians that are not participating in
the TRUST Study who reviewed and adjudicated all deaths,
strokes, surgical interventions, and cardiac adverse events that
occur during the study. The CEC also reviewed all divergent
classifications of actionable vs. non-actionable office follow up
visits between the physician and BIOTRONIK, and reviewed a
random sampling of 1% of office follow up visits in which there is
no disputed classification.
6.4.3 Summary of Clinical Results
The study involved 1443 patients (1038 males, 71.9%), with a
mean age of 63.5 years (range: 20-95). The cumulative
enrollment duration is 18,367
months with mean enrollment
duration of 12.7 months. The patient follow-up compliance rate
for all enrolled patients is 87.5% in Group 1 and 78.8% in
Group 2.
6.4.3.1 Primary Endpoint 1: Home Monitoring
Effectiveness
The purpose of primary endpoint 1 (HM efficacy) was to
compare the number of in-office ICD follow-ups for patients in
Group 1 (HM) to the conventional, calendar-based method of
ICD follow-up as in Group 2 (Control).
Detailed primary endpoint 1 results are presented in
Table 10
.
Table 10: Primary Endpoint Group 1 vs. Group 2
No. of
Pts**
Office Follow-up Visits
Scheduled Unscheduled Total
Group 1
(HM)
898
n
= 991
1.3 ± 1.0 per pt yr
13.1% actionable
n
= 401
0.6 ± 1.7 per pt yr
29.7% actionable
1.9 ± 1.9
per pt yr
Group 2
(Control)
414
n
= 1110
3.0 ± 1.1 per pt yr
10.7% actionable
n
= 117
0.4 ± 1.4 per pt yr
29.1% actionable
3.4 ± 1.7
per pt yr
p value
< 0.001 0.032
< 0.001
* Up to and including 12 month follow-up data