User Manual Part 4

CLINICAL STUDY - DECREASE HF
C-7
Table C-3. Composite score equivalence to BiV-CRT at six months
Statistic LV Offset BiV-CRT
N
a
Estimate ± SE
N
a
Estimate ± SE
3-Month Composite Score
71 12.4 ± 1.5 70 16.0 ± 1.5
6-Month Composite Score
70 12.8 ± 1.7 76 16.4 ± 1.7
Difference at 6 Months
(BiV-CRT - LV Offset)
3.6 ± 2.4
Confidence Interval Upper Bound
8.2
a. N refers to the number of patients with paired data.
Secondary Endpoints
Peak VO
2
––A patient’s capacity for performing physical activity was assessed
using six-month change in Peak VO
2
achieved during CPX testing. The
endpoint analysis includes only CPX tests that are representative of maximal
patient effort, defined as achievemen t of a Borg R PE ≥ 16 or RER ≥ 1.1.
As defined in the Protocol, patients with a baseline Peak VO
2
greater than
20 ml/kg/min were excluded from the analysis. A longitudinal analysis that
included all patients with data at a minimum of one visit was performed to
estimate six-month change from baseline in each group.
As shown in (Figure C -3 on page C-8) and Table C-4 on page C-8, both
treatment arms showed a statistically significant and clinically meaningful (≥
1.0 ml/kg/m in) improvement in Peak VO
2
, an endpoint considered clinically
meaningful in previous randomized controlled trials of CRT. The null hypothesis
was to be rejected if the lo wer one-sided 95% confidence bound were greater
than zero. The observed lower one-sided confidence bound for LV Offset is
1.1 ml/kg/min .
- DRAFT -