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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
10.3% 2 4.7%
Improved 1
class
47
48.5% 20 46.5%
Total
improved
57
58.8% 23 51.2%
No change 39
40.2% 20 46.5%
Worsened 1
class
1
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.