The FDA has granted Hansen Medical a nod of approval for its investigational device exemption (IDE) surrounding its ARTISAN AF clinical trial that will compare the use of the Sensei X Robotic Catheter system and Artisan Control Catheter, both used to treat atrial fibrillation (AF).
Mountain View, Calif.-based Hansen said that the agency approved the trial in May and the first cases of the ARTISAN AF trial have already been completed at the Texas Cardiac Arrhythmia Institute at St. David’s Medical Center in Austin, Texas.
The ARTISAN AF trial will enroll 300 patients who have symptomatic, drug-refractory paroxysmal AF to compare use of the robotic Sensei approach to AF treatment to manual AF treatment using the Artisan catheter. Patients will come from 14 sites.
The trial’s primary safety endpoint will be the onset of all major adverse events and the efficacy endpoint will be freedom of AF at one year.
The IntelliSense force sensing system will be used to guide ablative lesion placement. Under the trial's protocols, IntelliSense readings of 10g to 20 g during ablation—a maximum of 40g—are recommended.
The researchers will also compare the reduction in radiation exposures and the improvements in single-procedure success rates during the study. The trial will use Biosense Webster's line of cathethers (Navistar and Thermocool).