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Enrollment Underway in CLARITY-AF Study to Compare Efficacy, Safety and Efficiency of Two Catheter Ablation Technologies

Thu, 07/08/2010 - 5:35am
Bio-Medicine.Org

WATERLOO, Belgium, July 8, 2010 /PRNewswire/ -- 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) ( http://www.clinicaltrials.gov/ct2/show/NCT01116557?term=PVAC&rank=1).

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 t

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