3 results
1) Compare a group of bilateral users to a unilateral control group (between-subject design)2) Compare unilateral use to bilateral use after sequential implantation (within-subject design)3) Compare simultaneous bilateral implantation to sequential…
To demonstrate the safety and effectiveness of the IntellaNav StablePoint Catheter and Force Sensing System with DIRECTSENSE for treatment of drug refractory, recurrent, symptomatic Paroxysmal Atrial Fibrillation (PAF).
To characterize the PK of eltrombopag at steady state after oral administration in pediatric patients with SAA.Secondary (key only, see protocol page 40-41 for all objectives): Safety and tolerability. Efficacy (overall response rate ORR).