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60 Stratos LV/LV-T Technical Manual
Multi-site Poolability and Gender Analysis
The OPTION CRT/ATx clinical report includes data from multiple
centers with centralized coordination, data processing, and
reporting at BIOTRONIK. All of the clinical centers followed the
requirements of an identical clinical protocol, and all of the
clinical centers used the same methods to collect and report the
clinical data. In order to justify pooling of the data from multiple
centers, several analyses were completed. All of the centers
were divided into two groups based on implant volume.
Comparisons were then made between the patient populations
based on the results of each of the endpoints. Additionally,
analyses were performed on the data collected in the
OPTION CRT/ATx clinical investigation in order to compare
results between males and females. The first type of analysis
compared enrollment by patient gender in each of the study and
control groups. The second type of analysis compared
effectiveness outcomes in each gender.
The results of these analyses demonstrate poolability of the data
between sites. There were no significant differences in the
second primary endpoint or any of the secondary endpoints
between high and low volume implant centers.
The gender distribution in this clinical investigation is consistent
within the study groups and includes a representative proportion
of enrolled female participants (28.0% versus 72.0% male).
There were no significant differences in any of the primary or
secondary endpoints between the male and female population.