CryoCath’s Arctic Front for atrial fibrillation
This article was originally published in The Gray Sheet
Executive Summary
Pivotal stage of the STOP AF trial assessing CryoCath's Arctic Front cryo-balloon catheter for treating atrial fibrillation gains conditional FDA investigational device exemption. Patient enrollment will begin within "weeks," the firm says Sept. 5. The randomized, five-center study will include 75 highly symptomatic paroxysmal AF patients who have failed at least one anti-arrhythmic drug, and will compare Arctic Front treatment with standard drug therapy. The trial's primary endpoint will be absence of AF at 12-month follow-up. Originally expected to begin in Q2, the trial has been delayed by device design changes (1"The Gray Sheet" April 10, 2006, In Brief)...