User Manual Part 4

CLINICAL STUDY - C ONTAK CD
D-33
• Patients in the FCS had baseline measurements performed prior to implant.
Patients in the CONTAK CD Study had baseline measurements performed
post-implant, but before programming of the randomized therapy.
• Seventy-seven percent of patients in the FCS (98 of N = 127) were on beta
blockers compared to 42% in the CONTAK CD Study (95 of N = 227).
• Forty-nine percent of patients in the FCS (62 of N = 127) had ischemic
etiology compared to 68% in the CONTAK CD Study (154 of N = 227).
Endpoints
The prim ary endpoints of the study were Peak V O
2
and Six-M inu te Walk
distance. The study was designed to show a mean change of at least
1ml/kg/min and a 95% lower confidence bound (LCB) at least 0.5 ml/kg/min.
The study was also designed to detect a statistically significant improvement
in the Six-Minute Walk distanc e at a one-sided significance level of 0.10.
Additionally, two ancillary analyses of Quality of Life Score and NY HA Class
had to demonstrate a c hange that was directionally favorable towards CRT
using descriptive statistics.
Study Results
Study results for the Focused Confirmatory Study include the following:
•PeakVO
2
––a statistically significant improvement from baseline of 0.94 ±
0.30 ml/kg/min with a 95% LCB of 0.45 was observed in Peak VO
2
after six
months of CRT
• Six-Minute Walk––statistically significant improvements versus baseline
were observed in Six-Minute Walk distance after six months of CRT with an
observed mean improvement of 50.9 ± 10.4 m with a 95% LCB of 37.6 m
• Quality of Life––consistent with the other analyses, a statistically significant
improvement of 23.9 ± 2.6 points was observed in the Quality of Life score
after six months of CRT w ith a 95% LCB of 19.7 points
• New York Heart Association Class––after six months of CRT, a statistically
significant improvement in NYHA Class was observed with 60.4% of
patients improving one or more NYHA Class
- DRAFT -