Use Instructions
49
Other safety endpoints included all-cause death, cardiovascular death, composite rate of
all-cause death or all-cause hospitalizations, composite rate of cardiovascular death or
worsening heart failure-related hospitalizations, and overall rate of AEs and SAEs.
Demographics and Baseline Characteristics
Of the 160 eligible patients, 74 were randomized to the CCM group and 86 were
randomized to the control group. In the CCM group, 6 patients did not receive the device
and 2 patients died prior to the 24-week visit (including 1 patient who died prior to
randomization). In the control group, 4 patients died, and 3 patients withdrew prior to the
24-week visit.
The groups were well-balanced with regards to demographic and baseline characteristics
(Table 4). Overall, the mean age was approximately 63 years. The majority of patients
were white and male, and the etiology was predominantly ischemic cardiomyopathy,
characteristics which are typical of recent heart failure studies. Average peak VO
2
at
baseline was approximately 15 mL/kg/min, which is moderately reduced compared to the
normal population. Characteristics of the prospectively enrolled FIX-HF-5C patients were
similar to those of the FIX-HF-5 subgroup used for Bayesian analysis (Table 4).
Table 4: Demographic and Baseline Characteristics
FIX-HF-5C
FIX-HF-5 Subgroup
(25% ≤ EF ≤ 35%)
CCM
(N=74)
Control
(N=86)
CCM
(N=117)
Control
(N=112)
Mean Age (years)
63
63
59
60
Male
73%
79%
71%
74%
White
74%
71%
75%
72%
Ischemic Heart Failure
62%
59%
72%
69%
Prior MI
49%
59%
67%
59%
Prior PM/ICD System
88%
85%
80%
79%
Diabetes
51%
49%
49%
52%
NYHA
Class III
Class IV
87%
14%
91%
9%
93%
7%
87%
13%
QRS Duration (ms)
103
104
99
101
LVEF (%)
33
33
31
32
LVEDD (mm)
58
60
57
56
Peak VO
2
(mL/kg/min)
15.5
15.4
14.6
14.8
Exercise Time (minutes)
11.4
10.6
11.3
11.7
6MHW (meters)
317
324
326
324
MLWHFQ (total score)
56
57
60
56
Mean or % (n/N)
Effectiveness Results
Primary Effectiveness Endpoint
The primary effectiveness endpoint was met. The model-based estimated mean
difference in peak VO
2
at 24 weeks between CCM and control groups was 0.84
mL/kg/min with a 95% Bayesian credible interval of (0.12, 1.55) mL/kg/min. The
probability that CCM is superior to control was 0.989, which exceeds the 0.975
criterion required for statistical significance of the primary endpoint.