Stratos LV/LV-T Technical Manual 27

Table 3: Current Cardiac Medications at Enrollment

 

Drug Category

Group 1

Group 2

Group 3

P-

 

 

 

N=42

 

N=50

 

N=25

value*

 

 

 

 

 

 

 

 

Anti-Arrhythmics

12

(28.6%)

10

(20.4%)

4 (16.0%)

0.480

 

 

Rate Control Medications

32

(76.2%)

43

(87.8%)

20(80.0%)

0.462

 

 

Anti-thrombic Agents

17

(40.5%)

19(38.8%)

11

(44.0%)

0.863

 

 

Anti-Coagulants

36

(85.7%)

40

(81.6%)

22

(88.0%)

0.686

 

 

ACE Inhibitors

16

(38.1%)

16

(32.7%)

8 (32.0%)

0.848

 

 

Angiotensin-Receptor

10

(23.8%)

7 (14.3%)

4 (16.0%)

0.491

 

 

Blockers

 

 

 

 

 

 

 

 

 

 

 

Diuretics

30

(71.4%)

34

(69.4%)

13

(52.0%)

0.255

 

 

Inotropes

1

(2.4%)

2

(4.1%)

0

(0.0%)

0.803

 

 

Nitrates

3

(7.1%)

6 (12.2%)

2

(8.0%)

0.714

 

 

Beta-Blockers for CHF

6 (14.3%)

9 (18.4%)

4 (16.0%)

0.947

 

 

Other

23

(54.8%)

26

(53.1%)

14

(56.0%)

0.941

 

*Chi-Square test (2-sided)

Safety and Effectiveness Results

A total of 118 patients were enrolled in the AVAIL CLS/CRT clinical study at 20 sites:

There were 43 Group 1, 50 Group 2, and 25 Group 3 patients in this prospective, multi-center, randomized clinical study. For Group 1, there were 33 successful implants (76.7%) of the Protos DR/CLS system. For Groups 2 and 3, there were 44 and 21 successful implants (88.0% and 84.0%) respectively of the Stratos LV CRT-P system.