CryoCath Begins U.S. Trial for Atrial Fibrillation
The first patient has been treated in CryoCath Technologies' STOP AF (Cryo System Trial Of Paroxysmal Atrial Fibrillation) trial - an investigational device exemption (IDE) trial using the company's Arctic Front catheter for AF.
The principal investigator of the study, Douglas Packer from the Mayo Clinic, Rochester, Minn., performed the procedure. The procedure resulted in an acute success, with all four pulmonary veins electrically isolated using only the Arctic Front catheter. Three of the four veins were electrically isolated with one lesion application. There were no complications or safety concerns arising from the procedure.
The trial will initially treat approximately 20 AF patients at two U.S. centers in support of the next larger pivotal stage. Initial three-month follow-up data on the first set of patients is expected to be available in the fourth quarter. The study will see the use of two CryoCath catheters, Arctic Front to treat AF and Freezor MAX to treat atrial flutter when concomitant to AF and to touch up gaps when the Arctic Front cannot fully isolate the veins.
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