Hansen Medical has announced Food and Drug Administration (FDA)-approval of an expanded protocol for the ARTISAN-AF IDE study. The amended protocol now includes the use of the Thermocool SmartTouch catheter (BioSense Webster) and the EnSite Velocity Cardiac Mapping System (St Jude Medical).
These technologies are used in conjunction with the Sensei Robotic System to complete ablation procedures for the treatment of paroxysmal atrial fibrillation per the investigational device exemption (IDE) study protocol.
“There is a substantial amount of innovation in the treatment of atrial fibrillation for catheter ablation, including distal tip contact force sensing catheters like SmartTouch,” says Joe Gallinghouse, St David’s Medical Center, Austin, USA, and principal investigator of the ARTISAN-AF IDE study. “Early studies have indicated that the combination of SmartTouch and Sensei robotic navigation could provide improved outcomes for patients.”
Research has shown that the quality of ablation lesions is based on a combination of the contact between the catheter tip and heart wall, the power of the applied radiofrequency energy, and the amount of time the energy is applied. The Thermocool SmartTouch contact force sensing ablation catheter provides an objective measure of contact for optimal lesion creation. Hansen Medical believes that the stability and control of the Sensei system have the potential to improve contact between the catheter tip and heart wall.
The EnSite Velocity Mapping System facilitates 3D navigation of catheters in the heart atria. Sensei’s CoHesion feature offers physicians improved catheter control by integrating the EnSite Velocity 3D map into the navigation function of Sensei’s physician workstation.
“The Sensei Robotic System is a platform technology that enables electrophysiology procedures. It is important to keep pace with innovation in our field,” says Cary Vance, Hansen Medical president and chief executive officer. “By including innovative technologies in our clinical studies, we hope to offer even more benefit to physicians and patients.”
The ARTISAN AF trial is a prospective, single arm study of the Hansen Medical Sensei Robotic System for introducing and positioning certain irrigated radio frequency ablation catheters in patients with atrial fibrillation. The trial will enrol patients with symptomatic, drug-refractory paroxysmal atrial fibrillation and evaluate robotic technique for the ablation of atrial fibrillation. There are two primary endpoints: safety, defined as the absence of early onset of all major adverse events, and efficacy, defined as freedom from atrial fibrillation through one year.