More than ten patients have signed up to a clinical study comparing the efficacy, safety and efficiency of Carto 3 System guided radiofrequency ablation using the NaviStar ThermoCool (Biosense Webster) catheter versus fluoroscopy guided radiofrequency ablation using the Pulmonary Vein Ablation catheter (PVAC, Medtronic) in patients with paroxysmal atrial fibrillation.
Led by Biosense Webster, this prospective, multicentre, randomised, controlled, two-arm clinical study aims to enrol up to 350 patients at up to 15 sites throughout Europe. Patients will be followed for one year after ablation. Interim results will be disclosed after completion of the enrolment phase and the final results will be available at the end of the one year follow up period.
Entitled CLARITY-AF, the study will test the hypothesis that the NaviStar ThermoCool catheter using the Carto 3 System is superior to Medtronic’s fluoroscopy-guided PVAC for efficacy and safety.
“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,” believes Mattias Duytschaever from AZ St Jan Hospital in Bruges, Belgium, principal investigator of the CLARITY-AF study.
