Biosense Webster announced that this week it has obtained its first Ethics Committee approval for the Clarity study, comparing the one-year efficacy, safety and efficiency of Carto 3 System-guided radiofrequency ablation using the Navistar Thermocool Catheter versus fluoroscopy-guided radio frequency ablation using the Pulmonary Vein Ablation Catheter (PVAC, Ablation Frontiers, Medtronic) in patients with paroxysmal atrial fibrillation.
This prospective, multi-centre, randomized (2:1), controlled, two-arm clinical study will enrol up to 350 patients at up to 15 sites throughout Europe and Canada. The one-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 professor Mattias Duytschaever, principal investigator of the Clarity study.
With this study Biosense Webster shows its commitment to work towards a cure for atrial fibrillation and improve the quality of life of patients suffering from this disease, and be the #1 in rhythm solutions globally. Atrial fibrillation is the most prevalent heart rhythm disorder, increasing in prevalence with age. Clinical data suggest that 20% of all strokes result from the illness, which often remains undiagnosed and which can increase the risk of a stroke fivefold.
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, according to Marcia S Yaross, vice president, Worldwide Clinical, Regulatory and Health Policy, Biosense Webster. "We look forward to working with experienced Pvac and Navistar Thermocool users in Europe and Canada to evaluate this hypothesis."
Carto 3 System is the third generation of the Carto electro-anatomical mapping System, which brings the technology to an unprecedent level of performance. The system has been designed based on the feedback provided by several of the most prominent Key Opinion Leaders in the atrial fibrillation treatment arena. 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.
Biosense Webster, a Johnson & Johnson company, pioneered electrophysiology diagnostic catheters more than 30 years ago and continues to lead the industry as an innovative provider of advanced diagnostic, therapeutic and mapping tools.