User Manual Part 4

B-30
CLINICAL STUDY - COMPANION
DATA ANALYSIS AND RESULTS - COMPANION SUB-STUDY
The Exercise Performance Sub-study consisted of the following components.
CRT Effectiveness
Primary Co-primary endpoint consisting of Peak VO
2
derived from a
symptom-limited exercise test and Six-Minute Walk, with CRT results pooled
from the CONTAK TR and CONTAK CD arms.
Effectiveness was determined by assessing both Peak VO
2
and Six-Minute
Walk distance improvements with CRT compared to OPT.
Prospectively, success was defined as occurring if either of the following
occurred:
•PeakVO
2
improved ≥ 0.7 ml/kg/min (p < 0.05) and 6 MWD improvement
resulted in p < 0.10
•PeakVO
2
improved ≥ 0.5 ml/kg/min (p < 0.10) and 6 MWD improvement
resulted in p < 0.05
Additional: Quality of Life as measured by the Minnesota Living with Heart
Failure Questionnaire
®
‚ and NYHA Class
- DRAFT -