Use Instructions

62
Secondary Effectiveness Analyses
Since the primary endpoint was met, the secondary endpoint of total CCM delivery could be formally tested. Total CCM delivery is presented in
Table 19 for the IP populations. Results are presented for all available data and for the multiple imputation approach as described previously.
Although all subjects in FIX-HF-5C2 were implanted, 1 subject in the FIX-HF-5C OPTIMIZER group died prior to study start and an additional 5
subjects were not implanted, so the IP population differs for the FIX-HF-5C study used in comparison. As can be seen in Table 19, for all available
data and imputed data, the total CCM delivery at 24 weeks is equivalent between the OPTIMIZER groups of the FIX-HF-5C2 and FIX-HF-5C
studies since the 95% confidence interval of the difference between the 2 groups lies wholly within the interval defined by (Θ
L
,Θ
U
).
Table 19: Secondary Efficacy - OPTIMIZER Interrogation: IP Population
FIX-HF-5C2
FIX-HF-5C
FIX-HF-5C2 Bsl
Permanent AFIB
Variable
OPTIMIZER (N=60)
OPTIMIZER (N=60)
Difference
1
OPTIMIZER (N=9)
Total CCM Delivery
24 Weeks
Mean ± SD (n)
19892 ± 3472 (59)
19583 ± 4998 (67)
310 ± 4352
19734 ± 4187 (9)
(min, max)
(11618, 28284)
(3645, 31009)
(12787, 24578)
[95% CI]
[18988,20797]
[18364,20802]
[-1228, 1847]
[16515,22952]
P-value
2
0.691
(Θ
L
,Θ
U
)
(-2448,2448)
Total CCM Delivery (IMPUTED)
24 Weeks
Mean ± SE
19897 ± 463
19618 ± 610
279 ± 783
(min, max)
(19811, 20037)
(19553, 19722)
[95% CI]
[18988,20805]
[18421,20814]
[-1256,1813]
P-value
2
0.722
(Θ
L
,Θ
U
)
(-2452,2452)
1
Bioequivalence is conceded if the two-sided 95% confidence interval, for the difference, is completely contained within the interval (Θ
L
,Θ
U
).
2
P-value for mean from the two-sample t-test for the difference between groups.