Boston Scientific 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 FARAFLEX Mapping and PFA Catheter is 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.
Tobias Reichlin is head of electrophysiology and rhythmology, professor of medicine, Department of Cardiology, Bern University Hospital, Inselspital, Switzerland.
He said: “The FARADIGM trial is an important step to evaluate how a mapping-guided pulsed field ablation workflow performs in clinical practice, with a catheter specifically designed to deliver both high-density mapping and PFA.
“As the data continue to emerge, the study could contribute evidence on the role of integrated map-and-ablate workflows in atrial fibrillation treatment, to better identify and target cardiac arrhythmias.”
Atrial fibrillation is the most common sustained cardiac arrhythmia, affecting over 1.4 million people in the UK alone.
Left untreated, AF puts patients at significant risk of stroke – a leading cause of disability that costs the NHS and wider economy billions each year.
