Biosense Webster, Inc., a worldwide leader in the diagnosis and treatment of cardiac arrhythmias, announces that more than 10 patients have now been enrolled in the CLARITY-study ("CLARITY-AF"), comparing the efficacy, safety and efficiency of CARTO(R) 3 System guided radiofrequency ablation using the NAVISTAR(R) THERMOCOOL(R) catheter versus fluoroscopy guided radiofrequency ablation using the Pulmonary Vein Ablation catheter(R) (PVAC(R), Ablation Frontiers, Medtronic) in patients with paroxysmal atrial fibrillation (Clinicaltrials.gov ID NCT01116557).
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. Patients in this study will be followed for one year after ablation. The study is intended to test the hypothesis that the NAVISTAR(R) THERMOCOOL(R) catheter using the CARTO(R) 3 System is superior to fluoroscopy-guided PVAC(R) for efficacy and safety and will demonstrate non-inferiority for efficiency comparing the NAVISTAR(R) THERMOCOOL(R) catheter used with the CARTO(R) 3 System to the PVAC(R) catheter. Interim results from the study will be disclosed after completion of the enrollment phase and the final results will be available at the end of the 1-year follow up period.
"The CLARITY-AF trial is the first multi-center randomized trial comparing atrial fibrillation ablation devices. This trial will compare the Medtronic PVAC(R) catheter to the Biosense Webster NAVISTAR(R) THERMOCOOL(R) catheter. Primary endpoints are freedom from any atrial fibrillation, atrial tachycardia, pulmonary vein stenosis and procedure time. Given the growing epidemic of atrial fibrillation, the results of this trial will guide optimal treatment in a large patient population" said Prof. Mattias Duytschaever from AZ St Jan Hospital in Bruges, Belgium, and principal investigator of the CLARITY-AF study.
With this study Biosense Webster shows its commitment to working towards a cure for atrial fibrillation and improving the quality of life of patients suffering from this disease. Atrial fibrillation is the most prevalent heart rhythm disorder, increasing in prevalence with age. Clinical data suggests that 20% of all strokes result from the illness, which often remains undiagnosed and which can increase the risk of a stroke fivefold.
"The CLARITY-AF study will rigorously evaluate the efficacy, safety and efficiency of the Biosense Webster NAVISTAR(R) THERMOCOOL(R) catheter with CARTO(R) 3 System guidance compared to the Medtronic Pulmonary Vein Ablation catheter(R) (PVAC(R)) with fluoroscopy for treating paroxysmal atrial fibrillation. With enrollment now started, we are confident that this scientific study will demonstrate objective results that will show the superiority of the NAVISTAR(R) THERMOCOOL(R) catheter system for treating atrial fibrillation", according to Shlomi Nachman, World Wide President of Biosense Webster. "We look forward to releasing the early results next year."
CARTO(R) 3 is the third generation of the CARTO(R) electro-anatomical mapping system, which brings the technology to an unprecedented 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(R) 3 is built on the core magnetic based CARTO(R) proprietary technology, which has been recognized as the gold standard in its domain, with a special focus on increased performance, ease of use and Electrophysiology-lab efficiency.
The NAVISTAR(R) THERMOCOOL(R) catheter, manufactured by Biosense Webster, Inc. is one of the most widely adopted catheters 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 atrial fibrillation when used with CARTO(R) Navigation Systems.
According to data which appeared earlier this year in JAMA (Journal of American Medical Association, January 2010), patients with a common heart rhythm disorder, called atrial fibrillation, who were treated with catheter ablation using the NAVISTAR(R) THERMOCOOL(R) catheter, demonstrated significantly better outcomes at one year compared to those receiving drug therapy. In addition, the patients treated with catheter ablation reported markedly fewer symptoms and substantially improved quality of life.
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