60 Stratos
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.