User Manual

Lumax Technical Manual 47
Table 18: Peak VO2 Testing Results – Patients with RER
 1
Results Study Control
Peak VO
2
(ml/kg/min)
N=32
Baseline:
Mean:
13.46 ± 0.57
Range:
6.9 to 21.1
Six-Month:
Mean:
13.39 ± 0.53
Range:
7.6 to 20.70
Difference:
Mean:
-0.06 ± 0.42
Range:
-7.9 to 4.9
N=10
Baseline:
Mean:
12.58 ± 0.75
Range:
8.0 to 14.8
Six-Month:
Mean:
12.89 ± 0.94
Range:
7.0 to 17.2
Difference:
Mean:
0.31 ± 0.67
Range:
-2.7 to 4.6
1.6.2.11 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.