Stratos LV/LV-T Technical Manual 59

There are no clinically relevant differences in the six minute walk test results between the study and the control group.

2.The purpose of this secondary endpoint is to evaluate the improvement in the patient’s NYHA classification. Table 17 summarizes the average improvement in NYHA from Baseline to Six-Months for 140 patients that were able to complete both NYHA classification evaluations.

Table 17: Improvement in NYHA Classification atSix-Months from Baseline

 

 

Study

 

Control

 

Change in

(N=97)

 

(N=43)

 

 

 

 

 

% of

 

NYHA class

Number of

% of Total

Number of

 

Total

 

 

Patients

Patients

Patients

 

 

Patients

 

 

 

 

 

 

 

Improved 2

10

10.3%

2

 

4.7%

 

classes

 

 

 

 

 

 

 

 

Improved 1

47

48.5%

20

 

46.5%

 

class

 

 

 

 

 

 

 

 

Total

57

58.8%

23

 

51.2%

 

improved

 

 

 

 

 

 

 

 

No change

39

40.2%

20

 

46.5%

 

Worsened 1

1

1.0%

1

 

2.3%

 

class

 

 

 

 

 

 

 

The study and the control group have similar NYHA classes and similar rates of improvement in NYHA class from Baseline to the Six-Month follow-up.