C. R. Bard, Inc. (Bard), a developer of products for vascular, urology, oncology, and surgical specialty markets, is planning to complete the MAGELLAN trial for BARD HD MESH Ablation System by June 2011. The aim of the study is to determine if the HD Mesh Ablation System is as safe as and more effective than anti-arrhythmic drugs for patients with paroxysmal atrial fibrillation. The study is being conducted across US.
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.”