The US Food and Drug Administration (FDA) has given conditional approval to Hansen Medical to change the company’s study design of its ARTISAN-AF trial, a pivotal clinical trial evaluating the use of the Artisan family of control catheters (Hansen Medical) with its Sensei X Robotic Catheter System for treatment of atrial fibrillation (AF).
Under the revised protocol, this trial will be a single arm, target performance goal study and will enrol 100 patients at up to 14 investigational sites. The study will track two primary endpoints: Safety, defined as the incidence of early onset major adverse events and major complications through six months, and efficacy, defined as freedom from AF through one year. Additionally, data will be collected to measure radiation exposure and single-procedure success rates.
The study will evaluate the use of the Sensei X System with the family of Artisan Control Catheters for introducing and positioning the Biosense Webster Navistar Thermocool Catheter in patients with paroxysmal AF. While the approval of the revised protocol is conditional, it permits immediate enrolment of new patients at the company’s existing study sites, subject to site institutional review board approval. The company announced that it intends to further modify the investigational plan to clarify data analysis information, but does not expect that these modifications will affect patient enrolment or data collection under the revised protocol.
The ARTISAN- AF study was unconditionally approved under an investigational device exemption by the FDA in October 2010 and was originally designed to enrol 300 patients at 14 leading hospitals, as a prospective, randomised study.
The principal investigator of the full trial is Andrea Natale, executive director for Texas Cardiac Arrhythmia Institute. The co-principal investigator is Joseph Gallinghouse, electrophysiologist, at the Texas Cardiac Arrhythmia Research Foundation (TCARF) and his team.
“We are excited about the opportunity to continue testing robotic navigation with the Hansen System,” said Natale.
“I am very pleased that the FDA has approved the new protocol design submitted by Hansen Medical,” said Gallinghouse. “This will greatly facilitate enrolment in the trial, and allow us to evaluate clinical endpoints in an expedited fashion. I look forward to the continuation of this critical study of ablation of atrial fibrillation using robotic navigation.”
“This study is an important step toward expanding our United States labeling to include use of our Artisan family of control catheters with our Sensei X Robotic System to navigate certain ablation catheters, and we believe this will be a positive factor in the growth of our US electrophysiology business given our expectation that the ARTISAN- AF study will enrol patients much more quickly than the previous study design,” said Bruce Barclay, president and CEO, Hansen Medical.