3 results
Number of patients with >=80% reduction of VT burden, i.e., any ICD-treated or highly-symptomatic VT episodes, at one year after STAR compared to the year before (including VTs during the 8 week-blanking period). Efficacy parameters will be…
The Primary Objectives for the study are:* Demonstrate the non-inferiority (NI) of lefamulin versus comparator with respect to the Early Clinical Response (96 ± 24 hours after the first dose of study drug) in the Intent to Treat (ITT) Analysis Set (…
The device, the cardiac arrhythmia software, is intended to record, store and analyze the heart rate data collected by a PPG sensor to provide the user with notifications of events that indicate an irregular heart rhythm. The information is not…