The FDA has granted St. Jude Medical an investigational device exemption for the IRASE AF (Irrigated Ablation System Evaluation for Atrial Fibrillation) trial, to evaluate its 12-port irrigated catheter ablation system to treat atrial fibrillation (AF).
According to the St. Paul, Minn.-based company, the multicenter, single-blind study will randomize 324 patients in two groups using the duo 12-port irrigated catheter ablation system with radiofrequency (RF) and another ablation system approved by the FDA to treat paroxysmal AF. In addition, the trial will investigate whether the irrigated ablation catheter can be indicated for treatment of symptomatic paroxysmal AF.
RF ablation is recommended as second-line treatment for AF for paroxysmal AF using antiarrhythmic medication fails, St. Jude said. The trial will examine primary endpoints of targeted pulmonary vein isolation and freedom from symptomatic AF for 12 months after follow-up.
“Technology innovation and enhancements to the catheters we use, such as the Duo tip, are potentially important to improving the safety and efficacy of these procedures as this therapy develops,” said the study’s lead author Andrea Natale, MD, of the Texas Cardiac Research Foundation.
The trial is expected to be completed within three years, according to St. Jude.