Biosense Webster announced on 9 April 2010 that it has obtained its first Ethics Committee approval for the CLARITY study, comparing the one-year efficacy, safety and efficiency of Carto 3 System-guided radiofrequency ablation using the NaviStar ThermoCool Catheter versus fluoroscopy-guided radiofrequency ablation using the Pulmonary Vein Ablation Catheter (PVAC, Ablation Frontiers, Medtronic) in patients with paroxysmal atrial fibrillation.
This prospective, multicentre, randomised (2:1), controlled, two-arm clinical study will enrol up to 350 patients at up to 15 sites throughout Europe and Canada. The one-year efficacy results are expected to be available by the second quarter 2012, whereas the safety and efficiency data for both procedures will already be available by second quarter of 2011.
“The CLARITY trial is the first randomised trial comparing the efficacy and safety of these existing ablation strategies for atrial fibrillation. Given the growing epidemics of atrial fibrillation, the results of this landmark trial will guide optimal treatment in a large patient population” said Mattias Duytschaever, principal investigator of the CLARITY study.
Carto 3 System is the third generation of the Carto electro-anatomical mapping system. Carto 3 System brings to the physician and his/her staff:
- Accurate visualisation (with Carto proprietary 3D mapping technology), which allows seeing up to five catheters in the anatomy with precision and clarity, while potentially minimising fluoroscopy exposure to patients, physicians and EP lab staff;
- Increased mapping speed, which enables to map as fast as moving the catheter, potentially shortening procedures and minimising the burden to patients;
- Streamlined workflow allowing the physician and the lab teams to work more efficiently saving lab resources and minimising potential for human errors;
- A new user interface designed for the EP lab, to shorten the learning curve for nurses and for other staff members;
- An improved connectivity for catheters, enabling better signal quality and minimising setup errors.
The NaviStar ThermoCool Catheter, manufactured by Biosense Webster is one of the most widely adopted catheter for the treatment of atrial fibrillation in Europe, and the only ablation catheter approved by the FDA for the treatment of drug refractory recurrent symptomatic paroxysmal AF when used with Carto Navigation Systems.