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

 

Study

 

Control

 

P-

 

 

Category

 

(N=133)

 

(N=67)

 

value

 

 

Specific CHF Medications

89

(66.9%)

45

(67.2%)

1.000**

 

 

ACE inhibitors

 

 

Angiotensin receptor blockers

21

(15.8%)

16

(23.9%)

0.180**

 

 

Beta blockers

111 (83.5%)

55

(82.1%)

0.843**

 

 

Cardiac glycosides (Digoxin)

60

(45.1%)

35

(52.2%)

0.370**

 

 

Diuretic

114 (85.7%)

57

(85.1%)

1.000**

 

 

Inotropes

1

(0.8%)

3

(4.5%)

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.