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Stratos LV/LV-T Technical Manual 55
Table 14 provides a summary of cardiac medications patients
were taking at the time of enrollment. Some categories may be
more than 100% as several categories allow more than one
response.
Table 14: Cardiac Medications at Pre-Enrollment
Drug
Category
Study
(N=133)
Control
(N=67)
P-
value
Specific CHF Medications
ACE inhibitors
Angiotensin receptor blockers
Beta blockers
Cardiac glycosides (Digoxin)
Diuretic
Inotropes
89 (66.9%)
21 (15.8%)
111 (83.5%)
60 (45.1%)
114 (85.7%)
1 (0.8%)
45 (67.2%)
16 (23.9%)
55 (82.1%)
35 (52.2%)
57 (85.1%)
3 (4.5%)
1.000**
0.180**
0.843**
0.370**
1.000**
0.110**
Anti-arrhythmics
34 (25.6%)
19 (28.4%)
0.735**
Nitrates
36 (27.1%)
14 (20.9%)
0.390**
*Student's t-test (2-sided) for means, **Fisher's Exact Test (2-sided) for 2
possible answers, ***Chi-Square test (2-sided) for more than 2 possible answers
Safety and Effectiveness Results
A total of 200 patients were enrolled in the OPTION CRT/ATx
clinical study at 25 sites:
There were 133 study patients and 67 active control patients in
this prospective, multi-center, randomized clinical study. For the
study group, there were 129 successful implants (91.4%) of the
Tupos LV/ATx CRT-D system. For the active control group,
there were 64 successful implants (92.2%) of the legally
marketed CRT-D systems.