User's Manual

20 – US-ENGLISH
Study Population. The table below summarizes inclusions.
Region
Date of
first
implant
Date of
last
implant
Data cut-
off date
Number
of
centers
Number
of
patients
US
14-Dec-
99
08-Mar-
00
14-Mar-
00
6
22
Europe
04-May-
99
26-Jul-99
14-Apr-
00
11
38
All
04-May-
99
08-Mar-
00
14-Apr-
00 (Eur),
14-Mar-
00 (US)
17
60
 Complication-free rate
Only European patients followed for at least 3 months:
Symbol
Parameter
Defender IV DR 612
N
Overall number of
patients
37
Pe*N
Number of successes
35
Pe
Observed
experimental
proportion
0.95
Ps
Null hypothesis
success rate
0.76
ES
Estimated standard
error of Pe
0.04
z´
Test statistic
(1)
4.75
p
Associated p-value
< 0,0001
(1) Statistical test: z´ = (Pe-Ps)/SE where SE = sqrt(Pe(1-Pe)/N)