Biosense Webster has obtained Ethics Committee approval for the Clarity study, comparing the 1-year efficacy, safety and efficiency of Carto 3 System-guided radiofrequency ablation using the Navistar Thermocool Catheter versus fluoroscopy-guided radiofrequency ablation using the Pulmonary Vein Ablation Catheter(R) (PVAC(R), Ablation Frontiers, Medtronic) in patients with paroxysmal atrial fibrillation.
Biosense said that the 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 hypothesis of the 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. It is built on the core magnetic based Carto technology with a special focus on increased performance, ease of use and EP lab efficiency.
Mattias Duytschaever, professor and principal investigator of the Clarity study, said: “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.”
Marcia Yaross, vice president of worldwide clinical, regulatory and health policy at Biosense Webster, said: “We look forward to working with experienced PVAC and Navistar Thermocool users in Europe and Canada to evaluate this hypothesis.”