Estella Pulse Generators - BIOTRONIK USA - News

38 Estella Pulse Generators Technical ManualThe review of the reasons for missing data showed the following mostcommon reasons as being:1. 23 patients were programmed with V pS, but 11 of these subjectsdid not have electronic data available.2. 63 subjects were programmed with AV-delay with Hysteresis, but25 of these subjects did not have electronic data available.3. 7 subjects were programmed with no Hysteresis, but 1 subject didnot have electronic data available.Review of the missing data revealed that this data would not have alteredthe main study results and did not raise additional concerns about theeffectiveness of the ACC feature.6.4.4.4 Primary Endpoint 1: Comparison of AutomaticAtrial Threshold Testing vs. Manual MeasurementIn total 93 pairs of measurements at the one month follow-upwere available with a mean ± standard deviation = 0.01 V ± 0.14 V,minimum = -0.7 V, maximum = 0.6 V. The two‐sided 95% confidenceinterval for the mean calculates to [-0.03 V, 0.02 V]. Since this interval isentirely included in the equivalence-defining interval [-0.2 V, 0.2 V] it canbe concluded that the two measurements can be regarded as equivalent,so the alternative hypothesis can be accepted.In 19 out of a total of 384 threshold tests (4.9%) the difference betweenthe automatic and manual atrial threshold was greater than ± 0.2 V.Detailed primary endpoint 1 results are presented in Table 9.Table 9: Mean Difference Between Triggered Automatic and ManualThreshold TestDifference inAtrium [V]AutomaticmanualItem Visit Type N Mean StdDev Min Median MaxPredischarge95 -0.01 0.11 -0.4 0.0 0.3One Month 93 -0.01 0.14 -0.7 0.0 0.6Three Month 103 -0.01 0.13 -0.5 0.0 0.7Six Month 93 -0.02 0.09 -0.4 0.0 0.3Total 384 -0.01 0.12 -0.7 0.0 0.7