Abbott CentriMag, Reference Manual, Page: 24 / 32

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Table 9. All CentriMag Clinical Study Enrollment
Clinical Study Indications for Use Total Patients Enrolled
Post-cardiotomy
Failure to Wean
From CPB
Other
Cardiogenic
Shock Trial
(G030052)
10 8 16 26
RVAS Trial
(G040029)
11 1 12
RVAS Post-
Approval Study
(H070004/S1)
0 25 25
Total 53 42 95
Study Population Demographics and Baseline Parameters
The demographics of the study populations are typical for studies of mechanical circulatory support devices performed in the US.
Demographic information for the four study populations is summarized in the table below.
Table 10. Demographics -All CentriMag System Clinical Studies
Clinical Study FTW
from CPB
Pivotal Trial
(G030052/S21) 9
Cardiogenic
Shock
Trial
(G030052) 10
RVAS
Trial
(G040029) 11
RVAS HDE
Post Approval
Study
(H070004/S1) 12
Patients (N) 32 26 12 25
Sex: Male 24 (75%) 15 (58%) 8 (67%) 20 (80%)
Female 8 (25%) 11 (42%) 4 (33%) 5 (20%)
Race: White 24 (75%)
4 (13%)
4 (13%)
N/A
13
N/A
13
19 (76%)
4 (16%)
2 (8%)
African American
Other
Age:
(mean years ± SD) 58 ± 13.8 59 ± 11.6 55 ± 14.3 53 ± 13.9
Hx of diabetes 12 (38%) 10 (39%) 2 (17%) N/A 13
Hx of cardiovascular
disease 29 (91%) 24 (92%) 12 (100%) N/A 13
Baseline hemodynamic and laboratory values for only the pivotal study of the post-cardiotomy failure to wean from CPB indication are
summarized in the following tables.
8
Estimated number of FTW subjects (± 2-3) within total enrollment in Cardiogenic Shock trial.
9
Pivotal FTW Trial enrolled 100% (32/32) FTW subjects.
10
The Cardiogenic Shock Trial (G030052) enrolled a mixed cohort of patients in CS, at least 27% FTW subjects.
11
The RVAS Trial (G040029) enrolled patients in post-cardiotomy cardiogenic shock following implantation of an LVAD, over 90% FTW subjects.
12
The RVAS HDE Post Approval Study enrolled no identified FTW subjects.
13
Not collected per study protocol.