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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