User Manual Part 4

C-6
CLINICAL STUD Y - DECREASE HF
STUDY RESULTS
Therapy Effectiveness
Primary Endpoint
Composite Score––Effectiveness of LV Offset was measured using a
Composite Score that combines six-month changes in Peak VO
2
and LVESD
(FigureC-2onpageC-6,TableC-3onpageC-7).Basedontheseestimatesof
clinically meaningful improv ement (1 ml/kg /min and -5 mm, for Peak VO
2
and
LVESD, respectively), a scaling facto r of 5 was chosen to give each component
approximately equal weight, as follows: Composite Score = (5 x change in
peak VO
2
) - (change in LVESD ).
To evaluate the effectiveness of LV Offset, the Composite Score was compared
to the control arm using a longitudinal analysis. The null hypothesis was to be
rejected if the upp er one-sided confidence bound of the difference were less
than 10 points.
The observed mean differences from the BiV-CRT control arm was 3.6 ± 2.4
in the LV Offset arm, with u pper one-sided confidence bound of 8.2 showing
statistical equivalence to BiV-CRT.
20
0
4
8
12
16
LV Offset BiV-CRT
6-month Composite Score
20
0
4
8
12
16
LV Offset
Difference from BiV-CRT in a 6-month Score
Acceptable
Boundary
All patients with peak VO
2
and LVESD data at a minimum of one visit, N=189
Figure C-2. Composite Score Equivalence to BiV-CRT at Six Mo nths
- DRAFT -