BioCentury
ARTICLE | Clinical News

NaviStar ThermoCool Irrigated Tip Catheter cardiovascular data

February 1, 2010 8:00 AM UTC

Data from a prospective, open-label trial in 167 patients who did not respond to at least 1 antiarrhythmic drug showed that catheter ablation with NaviStar met the primary endpoint of a significantly greater proportion of patients who were free from protocol-defined treatment failure at 9 months vs. patients receiving antiarrhythmic drug therapy (ADT) (66% vs. 16%, p<0.001). Treatment failure was defined as patients with documented symptomatic paroxysmal AF during the 9 month follow-up period, patients requiring repeat ablation after day 80, absence of entrance block confirmed in all pulmonary veins at the end of ablation procedure, changes in specified drug regimen after the 3 month healing and stabilization period post-ablation procedure or an adverse event requiring discontinuation of ADT. ...