Use Instructions

52
Table 8: Change in Peak VO
2
in Tests with RER ≥ 1.05 at 24 Weeks by Study
Difference (95% CI) in Peak
VO
2
(mL/kg/min) Between
Groups
p-value
(1-sided)
Pooled data
0.62 (0.11. 1.14)
0.009
FIX-HF-5C
0.43 (-0.25, 1.11)
0.1100
FIX-HF-5 -
Subgroup
0.83 (0.06, 1.61)
0.017
Safety Results
The incidence of AEs in this study was relatively low. Comparisons between the groups
did not show any statistical differences between CCM and control groups with respect to
any AE tabulated for the analysis.
Primary Safety Endpoint
The primary safety endpoint was met as shown in Table 9. The complication-free
proportion in the CCM group cohort was 89.7% (61/68) with lower confidence limit of
79.9% (one-sided alpha=0.025), which was greater than the pre-defined threshold of
70%. The majority of complications (5/7, 71.4%) were lead dislodgements.
Table 9: Primary Safety Endpoint (FIX-HF-5C, As Treated CCM Group Only)
Complication Free Rate
n/N (%)
95% LCL
95% UCL
61/68 (89.7%)
79.9%
95.8%
Secondary Safety Endpoints (FIX-HF-5C)
As shown in Table 10, the freedom from death, freedom from cardiovascular death,
and freedom from all-cause death or all-cause hospitalization at 24 weeks were
similar in both groups.
Table 10: Secondary Safety Endpoints at 24 Weeks (FIX-HF-5C)
Freedom from
CCM
Control
p-value
All-cause death
98.3%
95.3%
0.2549
Cardiovascular death
100%
96.5%
0.1198
All-cause death or all-cause hospitalization
78.1%
77.7%
0.9437