CryoCath receives FDA approval to start atrial fibrillation trial

By Elaine Rigoli

Tampa, Fla., Sept. 5 - The Food and Drug Administration has granted CryoCath Technologies, Inc. conditional approval for its STOP AF trial, allowing the company to proceed to the pivotal stage of its Investigational Device Exemption trial for the company's proprietary Arctic Front catheter to treat atrial fibrillation.

Conditional approval allows the Montreal-based pharmaceutical company to start the trial at five centers enrolling up to 75 patients.

Patients in the controlled trial will be randomized into two arms, with one cohort receiving cryoablation therapy with Arctic Front (the ablation cohort) and the other receiving currently prescribed drug therapies (the control cohort). For every two patients in the ablation arm, there will be one in the control arm.

Patients in the trial will be highly symptomatic paroxysmal atrial fibrillation patients who have failed at least one anti-arrhythmic drug, the company said.

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