Primary end-point results
The primary endpoint of the study was to prospectively measure the CRT
response rate at 6 months in subjects with the MPP feature activated
immediately after implant. Cardiovascular deaths were considered
non-responder. There were 79 subjects considered for this analysis. The
response rate was 64.6% (97.5% lower confidence bound (LCB): 53%).
Despite having a higher numerical responder rate, the LCB was
< 57% and thus the primary endpoint was not met at the
predefined 2.5% significance level.
There were 33 ischemic and 46 non-ischemic analyzable patients.
Non-ischemic patients had a significant higher response rate in
comparison to ischemic patients (73.9% vs 51.5%, p=0.039).
There were 25 subjects with device programmed using anatomical approach
and 54 using electrical approach. Finally, the subjects with device
programmed using anatomical approach had a numerically higher responder
rate than those using the electrical approach (72.0% vs. 61.1%, p=
0.33).