This phase III, randomized, single blind (outcomes assessor), parallel assignment, controlled trial currently recruiting approximately 369 participants. The study director is Anne Marie Harcarik Bard Electrophysiology, division of Bard.
BARD HD MESH Ablation System is intended to provide the ability to pace, record and deliver pulsed RF energy from a deployable mesh electrode array to an area of tissue surrounding the pulmonary veins to treat atrial fibrillation. The catheter is targeted to provide the electrophysiologist with a versatile device to rapidly map target tissues, deliver pulsed RF energy to ablate it and confirm that the desired tissue effect was achieved.
The official title of the trial is “A Randomized Controlled Trial of Radiofrequency Ablation for the Treatment of Paroxysmal Atrial Fibrillation Using the Bard High Density Mesh Ablation System.”
