June 15, 2012 —Endosense, a pioneer and leader in force-sensing technology focused on improving the efficacy and safety of catheter ablation for the treatment of cardiac arrhythmias, has announced enrollment completion in the TOCCASTAR clinical study. TOCCASTAR is a prospective, randomized, multi-center investigational device exemption (IDE) trial designed to evaluate the safety and effectiveness of the company’s TactiCath force-sensing ablation catheter in patients with symptomatic paroxysmal atrial fibrillation (AF).
TOCCASTAR study investigators enrolled 300 patients at 17 centers across the United States and Europe. All patients were randomized on a one-to-one basis for treatment with the TactiCath or a control radiofrequency catheter approved by the U.S. Food and Drug Administration (FDA) for treating paroxysmal AF.
The TOCCASTAR study will evaluate the safety and effectiveness of the TactiCath based on 12-month follow-up data from the index procedure. The primary effectiveness endpoint is a non-inferiority comparison of treatment success as defined by both acute procedural success and chronic freedom from symptomatic paroxysmal AF, atrial tachycardia and atrial flutter; the safety endpoint is a non-inferiority comparison of early onset device-related serious adverse events. Secondary endpoints include a superiority comparison of procedural effectiveness related to the use of the contact-force sensor.
“Contact-force sensing in the context of a radiofrequency ablation catheter represents a significant enhancement to the tools available to electrophysiologists treating AF. The idea that we can deliver intra-cardiac lesions will full knowledge of the quality of the electrode-tissue interface is very appealing,” said Vivek Reddy, M.D. TOCCASTAR principal investigator and director of the Cardiac Arrhythmia Service, The Mount Sinai Medical Center, New York. “When complete, TOCCASTAR will provide the first randomized comparison of treatment safety and success between a conventional radiofrequency catheter and one with contact-force sensing capability. Through the use of this important diagnostic feature, we are gaining singular insights into the challenges and techniques that define optimal cardiac ablation therapy.”
Endosense expects to use the results of the TOCCASTAR study to support a premarket approval application (PMA) to the FDA in the third quarter of 2013.