St. Jude Medical Inc. (STJ) announced it has received an Investigational Device Exemption or IDE from the U.S. Food and Drug Administration or FDA to begin enrollment in the IRASE AF or IRrigated Ablation System Evaluation for AF trial, a multicenter, randomized, single-blind study evaluating the safety and efficacy of the company's Duo 12 port open irrigated catheter ablation system for treatment of Atrial Fibrillation or AF.
AF is the most common cardiac arrhythmia (abnormal heartbeat). The trial is expected to take about three years to complete and will take place in both the U.S. and international markets with 324 patients.
The trial's primary efficacy endpoints are targeted pulmonary vein isolation (acute) and freedom from symptomatic AF for 12 months (chronic) following the procedure. The primary safety endpoints are freedom from acute major adverse events within seven days of the procedure and chronic major adverse events within 12 months, the company said.
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