During the Heart Rhythm Society (HRS) 2010 conference in Denver, Hansen Medical announced that the FDA had granted conditional investigational device exemption (IDE) approval, authorizing a clinical trial to investigate use of the Sensei X robotic catheter system and the Artisan control catheter for treatment of atrial fibrillation (AF).
The first case in the ARTISAN AF Trial, a pivotal clinical trial using the Sensei X system for the treatment of AF, was completed May 11 by Joseph Gallinghouse, MD, an electrophysiologist at the Texas Cardiac Arrhythmia Institute (TCAI) at St. David's Medical Center in Austin. The trial’s principal investigator is Andrea Natale, MD, executive medical director for TCAI.
“The trial will be conducted using the Navistar line of catheters, which are [Biosense Webster’s] FDA-approved ThermoCool catheters for AF ablation and the Carto system, along with Hansen’s Sensei X platform and Artisan Extend catheters,” Robert Mittendorff, MD, vice president of marketing and business development, told Cardiovascular Business News.
The trial will seek to enroll 300 patients with symptomatic paroxysmal AF at a 2:1 ratio to randomly evaluate robotic technique compared with a manual technique for the ablation of AF. The primary endpoints were freedom from acute adverse events at seven days (safety) and freedom from AF at three months through one year (efficacy).
“We anticipate enrollment to take six to nine months, and the patients will be followed out to a year,” Mittendorff said. “Following the trial, Hansen will be seeking approval in the U.S. for a label for ablation using that indicated catheter.”
He also noted that while the trial results will not directly speak to radiation exposure to both the patient and the operator, the company will be tracking those outcomes.