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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 at

Six-Months from Baseline

Study

(N=97)

Control

(N=43)

Change in

NYHA class

Number of

Patients

% of Total

Patients

Number of

Patients

% of

Total

Patients

Improved 2

classes

10.3% 2 4.7%

Improved 1

class

48.5% 20 46.5%

Total

improved

58.8% 23 51.2%

No change 39

40.2% 20 46.5%

Worsened 1

class

1.0% 1 2.3%

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.

1 2 ... 62 63 64 65 66 67 68 69 70 71 72 ... 171 172

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