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).