Estella Pulse Generators - BIOTRONIK USA - News

30 Estella Pulse Generators Technical Manual6.3.3 Summary of Clinical ResultsThe study involved 1443 patients (1038 males, 71.9%), with a meanage of 63.5 years (range: 20-95). The cumulative enrollment durationis 18,367 months with mean enrollment duration of 12.7 months. Thepatient follow-up compliance rate for all enrolled patients is 87.5% inGroup 1 and 78.8% in Group 2.6.3.3.1 Primary Endpoint 1: Home MonitoringEffectivenessThe purpose of primary endpoint 1 (HM efficacy) was to compare thenumber of in-office ICD follow-ups for patients in Group 1 (HM) to theconventional, calendar-based method of ICD follow‐up as in Group 2(Control).Detailed primary endpoint 1 results are presented in Table 6.Table 6: Primary Endpoint Group 1 vs. Group 2Group 1(HM)Group 2(Control)No. ofPts†898414Office Follow-up Visits*Scheduled Unscheduled Totaln = 9911.3 ± 1.0 perpt yr13.1%actionableN = 11103.0 ± 1.1 perpt yr10.7%actionablen = 4010.6 ± 1.7 perpt yr29.7%actionableN = 1170.4 ± 1.4 perpt yr29.1%actionable1.9 ±1.9per ptyr3.4 ±1.7per ptyrp value < 0.001 0.032 < 0.001AnalysisThe comparison of the number of 3, 6, 9, and 12 month and unscheduledoffice follow-up visits in Group 1 versus Group 2 showed that there wasan average number of 1.9 office follow-up visits on a per year basis inGroup 1 (HM) and an average number of 3.4 office follow-up visits on aper year basis in Group 2 (Control). Therefore, the null hypothesis (HØ)* Up to and including 12 month follow-up data† Number of patients that have contributed at least 1 follow-up