3 results
Effectiveness: To provide valid scientific evidence that use of the TactiCath® Set is an effective treatment for symptomatic paroxysmal atrial fibrillation (PAF).Safety: To provide valid scientific evidence that use of the TactiCath® Set is safe as…
Primary ObjectiveThe primary objective is to compare the annualized rates of bleeding episodes (ABR)between subjects receiving a prophylactic regimen of BAX 855 with an on-demandtreatment regimen.Secondary ObjectivesThe key secondary objective is to…
7.2 Primary ObjectiveThe primary objective is to assess the incidence of FVIII inhibitory antibodies(>=0.6 Bethesda units [BU] using the Nijmegen modification of the Bethesda assay).7.3 Secondary Objectives1. To evaluate the PK parameters of…