CLARITY trial looks at efficacy, safety and efficiency of catheter ablation of AF

THERMOCOOL® Catheter versus fluoroscopy-guided radiofrequency ablation using the Pulmonary Vein Ablation Catheter^® (PVAC^®, Ablation Frontiers, Medtronic) in patients with paroxysmal atrial fibrillation.

This prospective, multi-center, randomized (2:1), controlled, two-arm clinical study will enroll up to 350 patients at up to 15 sites throughout Europe and Canada. The 1-year efficacy results are expected to be available by Q2 2012, whereas the safety and efficiency data for both procedures will already be available by Q2 2011.

“The CLARITY trial is the first randomized trial comparing the efficacy and safety of these existing ablation strategies for atrial fibrillation. Given the growing epidemics of atrial fibrillation, the results of this landmark trial will guide optimal treatment in a large patient population” said Prof. Mattias Duytschaever, principal investigator of the CLARITY study.

The hypothesis of this trial is that treatment with the NAVISTAR® THERMOCOOL®  Catheter, with CARTO® 3 System guidance, will provide superior efficacy and safety for the treatment of paroxysmal atrial fibrillation vs. the PVAC^® catheter, without decreasing the efficiency of the ablation procedure.

CARTO® 3 System is the third generation of the CARTO® electro-anatomical mapping system. CARTO® 3 System is built on the core magnetic based CARTO® proprietary technology, which has been recognized as the gold standard in its domain, with a special focus on increased performance, ease of use and EP lab efficiency.

The NAVISTAR® THERMOCOOL® Catheter, manufactured by Biosense Webster, Inc. is one of the most widely adopted catheter for the treatment of atrial fibrillation in Europe, and the only ablation catheter approved by the U.S. Food and Drug Administration for the treatment of drug refractory recurrent symptomatic paroxysmal AFib when used with CARTO® Navigation Systems.