Use Instructions

54
examination, medication evaluation, blood testing, CPX test, NYHA assessment, and an
assessment of adverse events. Data collection for assessment of the study endpoints
was concluded with the 24-week visit.
Results
Number of Investigators and Number of Sites
There were 8 sites participating in the FIX-HF-5C2 study and 8 principal investigators
are shown in Table 11 below.
Table 11: List of Sites
Investigator/Investigational
Site
Screened
Enrolled
Site A
7
4 (6.7%)
Site B
33
18 (30.0%)
Site C
3
1 (1.7%)
Site D
43
12 (20.0%)
Site E
8
3 (5.0%)
Site F
14
3 (5.0%)
Site G
6
1 (1.7%)
Site H
39
18 (30.0%)
TOTAL
153
60
Accountability of Subjects with Study Visits
Table 12 contains patient disposition. There were 153 subjects screened. Of these
60 subjects were enrolled and all 60 subjects were implanted with the study device.
One subject withdrew prior to 24 weeks. There were no deaths. Follow-up by study
visit is presented in the table along with the number and percent of subjects who
successfully completed exercise testing for the primary endpoint. A total of 53
subjects returned for exercise testing at 12 weeks while 55 subjects completed the
exercise testing visit at 24 weeks. One (1) subject had his testing deemed inadequate
at 12 weeks while 3 subjects had inadequate tests at 24 weeks, leaving 52 evaluable
tests at 12 weeks and 52 evaluable tests at 24 weeks. One subject withdrew from the
study prior to 24 weeks.
Table 12: Patient Disposition
Variable
FIX-HF-5C2 OPTIMIZER
Screened
153
Enrolled / Implanted
60 (39.2%)
Per Protocol (PP)
59 (98.3%)
Died
1
0 (0.0%)
Withdrawn
1
1 (1.7%)
12 Week Visit Completed
59 (98.3%)
12 Week Exercise Tolerance Test Completed
53 (88.3%)
12 Week Exercise Tolerance Test Evaluable
2
52 (86.7%)
24 Week Visit Completed
59 (98.3%)
24 Week Exercise Tolerance Test Completed
55 (91.7%)
24 Week Exercise Tolerance Test Evaluable
2
52 (86.7%)
1
Prior to 24 Week Visit
2
Includes only subjects with valid Peak VO
2
, as determined by the core lab, at
the indicated visit.