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This prospective, multi-center, randomized (2:1), controlled, two-armclinical study will enroll up to 350 patients at up to 15 sites throughoutEurope. 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 tofluoroscopy-guided PVAC(R) for efficacy and safety and will demonstratenon-inferiority for efficiency comparing the NAVISTAR(R) THERMOCOOL(R)catheter used with the CARTO(R) 3 System to the PVAC(R) catheter. Interimresults from the study will be disclosed after completion of the enrollmentphase and the final results will be available at the end of the 1-year followup period.
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"The CLARITY-AF trial is the first multi-center randomized trialcomparing atrial fibrillation ablation devices. This trial will compare theMedtronic PVAC(R) catheter to the Biosense Webster NAVISTAR(R) THERMOCOOL(R)catheter. Primary endpoints are freedom from any atrial fibrillation, atrialtachycardia, pulmonary vein stenosis and procedure time. Given the growingepidemic of atrial fibrillation, the results of this trial will guide optimaltreatment in a large patient population" said Prof. Mattias Duytschaever fromAZ St Jan Hospital in Bruges, Belgium, and principal investigator of theCLARITY-AF study.
With this study Biosense Webster shows its commitment to working towardsa cure for atrial fibrillation and improving the quality of life of patientssuffering from this disease. Atrial fibrillation is the most prevalent heartrhythm disorder, increasing in prevalence with age. Clinical data suggeststhat 20% of all strokes result from the illness, which often remainsundiagnosed and which can increase the risk of a stroke fivefold.
"The CLARITY-AF study will rigorously evaluate the efficacy, safety andefficiency of the Biosense Webster NAVISTAR(R) THERMOCOOL(R) catheter withCARTO(R) 3 System guidance compared to the Medtronic Pulmonary Vein Ablationcatheter(R) (PVAC(R)) with fluoroscopy for treating paroxysmal atrialfibrillation. With enrollment now started, we are confident that thisscientific study will demonstrate objective results that will show thesuperiority of the NAVISTAR(R) THERMOCOOL(R) catheter system for treatingatrial fibrillation", according to Shlomi Nachman, World Wide President ofBiosense Webster. "We look forward to releasing the early results next year."
CARTO(R) 3 is the third generation of the CARTO(R) electro-anatomicalmapping system, which brings the technology to an unprecedented level ofperformance. The system has been designed based on the feedback provided byseveral of the most prominent Key Opinion Leaders in the atrial fibrillationtreatment arena. CARTO(R) 3 is built on the core magnetic based CARTO(R)proprietary technology, which has been recognized as the gold standard in itsdomain, with a special focus on increased performance, ease of use andElectrophysiology-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 atrialfibrillation in Europe, and the only ablation catheter approved by the U.S.Food and Drug Administration for the treatment of drug refractory recurrentsymptomatic paroxysmal atrial fibrillation when used with CARTO(R) NavigationSystems.
According to data which appeared earlier this year in JAMA (Journal ofAmerican Medical Association, January 2010), patients with a common heartrhythm disorder, called atrial fibrillation, who were treated with catheterablation using the NAVISTAR(R) THERMOCOOL(R) catheter, demonstratedsignificantly better outcomes at one year compared to those receiving drugtherapy. In addition, the patients treated with catheter ablation reportedmarkedly fewer symptoms and substantially improved quality of life.
About Biosense Webster, Inc.
Biosense Webster, Inc., a Johnson & Johnson company, pioneeredelectrophysiology diagnostic catheters more than 30 years ago and continuesto lead the industry as an innovative provider of advanced diagnostic,therapeutic and mapping tools. As one of the leaders in navigation systemsand ablation therapy, Biosense Webster, Inc.'s technology includes thelargest installed base of navigation systems worldwide in leading hospitalsand teaching institutions. With its proprietary products the company ischanging the way electrophysiologists diagnose and treat arrhythmias.
The third party trademarks used herein are trademarks of their respectiveownersContact: Ulrike Domany Director Public Affairs & Communication +43-1-36025-396 +43-664-83-504-83 [email protected]
SOURCE Biosense Webster, Inc.
