Mintek Pacemaker LV-T ユーザーズマニュアル

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.