Boston Scientific has announced that it has initiated the FARADIGM clinical trial—a global single-arm investigational device exemption (IDE) study evaluating the safety and effectiveness of the Faraflex mapping and pulsed field ablation (PFA) catheter for treating patients with paroxysmal and persistent atrial fibrillation (AF). The trial plans to enrol approximately 571 patients.
“The FARADIGM trial is an important step to evaluate how a mapping-guided PFA workflow performs in clinical practice, with a catheter specifically designed to deliver both high-density mapping and PFA,” said study investigator Tobias Reichlin (Bern University Hospital, Bern, Switzerland). “As the data continue to emerge, the study could contribute evidence on the role of integrated map-and-ablate workflows in AF treatment to better identify and target cardiac arrhythmias.”
The Faraflex mapping and PFA catheter is described by Boston Scientific as a novel large, focal high-density map-and-ablate catheter designed to combine detailed mapping of electrical activity in the heart and PFA to treat complex arrhythmias in patients with paroxysmal and persistent AF.
The device builds upon the Farapulse PFA ecosystem and integrates with the Opal HDx mapping system, which may help physicians better understand what areas of the heart to treat to deliver more targeted therapy, according to Boston Scientific.
