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38 Stratos LV/LV-T Technical Manual
Primary Effectiveness Endpoint Analysis and Conclusions
The primary effectiveness endpoint evaluated CRT effectiveness
(Groups 1 and 2) compared to RV only effectiveness (Group 3),
as measured by the composite rate of the six minute walk test
and QOL improvement from Baseline to the Six-Month follow-up
(Table 8
). For this analysis, both six minute walk test and QOL
were equally weighted at 50%. Due to the small number of
patients with data available for the analysis of the primary
endpoint, the results lack power to demonstrate that biventricular
pacing with either the Protos DR/CLS or Stratos LV device is
statistically different from RV only pacing with the Stratos LV
device in patients undergoing an “ablate and pace” procedure.
Multi-site Poolability and Gender Analysis
The AVAIL CLS/CRT clinical report included 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, including New York Heart Association evaluation,
six-minute walk test, Minnesota Living with Heart Failure
questionnaire, and echocardiographic measurements. In order
to justify pooling of the data from multiple centers, several
analyses were completed. All of the centers were divided into
two groups (Small and Large sites) based on implant volume.
Comparisons were then made between the patient populations
based on the results of the safety and effectiveness endpoints.
Additionally, analyses were performed on the data collected in
the AVAIL 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
groups. The second type of analysis compared effectiveness
and safety outcomes in each gender.
The results of these analyses demonstrated poolability of the
data between sites. There were no significant differences in the
primary safety or effectiveness endpoints between high and low
volume implant centers.