3 results
Verification of number of mode switches, Verification of undersensing of AFor other ATAs. Incidence of mode switches due to FFRW oversensing using Accent pacemaker in the most sensitive sensing setting(s)using the Optisense vrs Tendril lead
Primary:To determine the safety, tolerability, and pharmacokinetic (PK) profile of single ascending intravenous (iv) doses and of multiple ascending iv doses of FMX-8 in healthy subjectsSecondary:To evaluate the pharmacodynamics (PD) of FMX-8 in…
Protocol page 33:The purpose of the study is to provide data demonstrating the safety and effectiveness of the PFAsystem for the treatment of atrial fibrillation. The study will also provide first in human insights intoclinical safety and device…