58 Stratos LV/LV-T Technical Manual
Primary Effectiveness Endpoint Analysis and Conclusions
A composite rate of six minute walk test and QOL improvement from Baseline to the Six-Month follow-up is evaluated as a measure of CRT effectiveness. For this analysis both six minute walk test and QOL are equally weighted at 50%.
The mean difference in the composite rate between study and control group was 20.53% with an associated one-sided, 95% confidence bound of (-6.10%). The p-value for non-inferiority within 10% is 0.030. The analysis of the composite rate in six minute walk test distance and QOL score demonstrates that the study group is non-inferior to the control group and that the primary effectiveness endpoint was met (p=0.030).
Secondary Endpoint Results1.The purpose of this secondary endpoint is to evaluate improvement in functional capacity as measured by the six minute walk test. The six minute walk test is a well-accepted measure of functional capacity and exercise tolerance. Also, this test more closely mimics the patient’s day-to-day activities than maximal exercise testing.
Table 16 summarizes the six minute walk test distance at Baseline and the Six-Month follow-up for patients in the study group and the control group.
Table 16: Six Minute Walk Distance | Distance | Study | Control | |
| (meters) | |
| | | |
| Baseline | | | |
| N | 127 | 61 | |
| Mean ± SE | 283.14 ± 9.27 | 269.43 ± 13.77 | |
| Range | 23 to 511 | 29 to 507 | |
| Median | 302.00 | 244.00 | |
| Six-Month | 93 | 44 | |
| N | |
| Mean ± SE | 329.73 ± 10.82 | 310.70 ± 15.49 | |
| Range | 78 to 596 | 91 to 489 | |
| Median | 335.00 | 313.00 | |
* Student's t-test, 2-sided
