Study Population Demographics And Baseline Parameters - Abbott CentriMag Reference Manual

Table 9. All CentriMag Clinical Study Enrollment
Clinical Study
Cardiogenic
Shock Trial
(G030052)
RVAS Trial
(G040029)
RVAS Post-
Approval Study
(H070004/S1)
Total

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
Patients (N)
Sex: Male
Female
Race: White
African American
Other
Age:
(mean years ± SD)
Hx of diabetes
Hx of cardiovascular
disease
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.
Indications for Use
Post-cardiotomy
Failure to Wean
From CPB
10 8
11
0
53
FTW Cardiogenic
from CPB
Pivotal Trial
(G030052/S21) 9 (G030052)
32
24 (75%) 15 (58%)
8 (25%) 11 (42%)
24 (75%)
4 (13%)
4 (13%)
58 ± 13.8 59 ± 11.6
12 (38%) 10 (39%)
29 (91%) 24 (92%)
Other
16
1
25
42
RVAS
Shock Trial
Trial (G040029)
10
26 12
8 (67%)
4 (33%)
N/A 13 N/A
55 ± 14.3
2 (17%)
12 (100%)
25
Total Patients Enrolled
26
12
25
95
RVAS HDE
Post Approval
11 Study
(H070004/S1)
25
20 (80%)
5 (20%)
13 19 (76%)
4 (16%)
2 (8%)
53 ± 13.9
N/A 13
N/A 13
12