Biosense Webster, Inc. (Biosense), is planning to complete the phase III trial called “NAVISTAR THERMOCOOL Catheter for the Radiofrequency Ablation of Symptomatic Paroxysmal Atrial Fibrillation- Treatment Use Study” for NAVISTAR THERMOCOOL Irrigated-tip Catheter by June 2010. The study purpose is to evaluates the safety and effectiveness of catheter ablation for paroxysmal atrial fibrillation.
The prospective, non-randomized, multi-center trial is being conducted in various locations of US with an estimated enrollment of 100 subjects. The study is ongoing, but not recruiting participants. The study Principal Investigator is David Wilber, MD from Loyola University Medical Center Chicago.
NAVISTAR THERMOCOOL irrigated-tip catheter is the first power controlled, open-loop irrigated catheter. It is designed to maintain lower tip-to-tissue temperatures so that one can deliver the power they need. It is currently FDA-approved for commercial distribution in the US for treating patients with Type I atrial flutter and drug refractory Ventricular Tachycardia for MI patients. The catheter is approved for use in Europe for endocardial ablation for treating cardiac arrhythmias.