Estella Pulse Generators - BIOTRONIK USA - News

34 Estella Pulse Generators Technical Manual6.3.4 Conclusions• Use of HM in Group 1 resulted in an average of 1.9 office visits perpatient year in the 12 months post-implant, versus an average of3.4 office visits per patient year in Group 2, a 44% reduction in officevisits. The average number of office visits is significantly less in theHM group than in the Control group (p < 0.001).• The safety event rate for a 12 month duration for Group 1 (HM) wasnon-inferior to the safety event rate for Group 2 (Control) within5% (p = 0.005). The upper, one-sided 95% confidence bound for thedifference was 2.7%.• The mean time from onset to evaluation of AF, VT and VF eventsindicates that those events for Group 1 patients are evaluated insignificantly less time when compared to Group 2 patients (AFp = 0.005, VT p < 0.001, VF p < 0.001).6.4 Atrial Capture Control (ACC) and Ventricular PacingSuppression (V pS)The Evia Master Study was used to support the safety and effectivenessdetermination of the ACC and V pSuppression features for the Evia familyof pulse generators6.4.4.1 Primary ObjectivesThe clinical study included evaluation of the safety and effectiveness ofthe ACC feature to demonstrate that the feature functions appropriately.6.4.4.2 MethodsA total of 175 patients were implanted with Evia pulse generators andwere enrolled in a controlled, prospective study. The investigation wasconducted at 34 centers. The average patient was a 74 year-old (52.6%male, 47.4% female), having an intermittent or complete AV block(48.6%) and/or symptomatic bradycardia (41.7%).Primary EndpointThe purpose of primary endpoint 1 (ACC efficacy) was to comparethe mean automatic atrial pacing threshold measurements of theACC algorithm to the mean manual right atrial pacing thresholdmeasurement at one-month follow-up. The associated hypothesisis evaluated based on the difference in the mean ACC and manualthresholds as smaller than 0.2 V and greater than -0.2 V.