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Biosense Webster Inc.

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CLARITY-AF Study Underway

Enrolement is Underway in the CLARITY-AF Study which compares Efficacy, safety and efficiency of two catheter ablation technologies.

Biosense Webster, Inc., has announced 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 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.

CARTO(R) 3 is the third generation of the CARTO(R) electro-anatomical mapping system. The system is built on the core magnetic based CARTO(R) proprietary technology, with a special focus on increased performance, ease of use and Electrophysiology-lab efficiency.

Published on: July 22, 2010

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ENDORSED BY

  • ArrhythmiaAlliance
  • Stars
  • Anticoagulation Europe
  • Atrial Fibrillation Association
 

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