Endosense has announced first patient enrollment in the TOCCASTAR (TactiCath COntaCt ForCe Ablation catheter STudy for Atrial fibRillation) clinical study to assess its catheter ablation technology for the treatment of cardiac arrhythmias.
Study investigator Petr Neuzil, MD, PhD, from the cardiology department at Na Homolce Hospital in Prague, Czech Republic, undertook the first procedure.
TOCCASTAR is a prospective, randomized, multicenter, investigational device exemption clinical trial designed to evaluate the effectiveness and safety of the TactiCath force-sensing ablation catheter for the treatment of symptomatic paroxysmal atrial fibrillation (AF). Results of the study will be used to support a premarket approval application to the FDA for clearance of the TactiCath catheter and accompanying TactiSys system, according to the Geneva-based company.
In the trial, researchers will seek to enroll 300 patients at up to 30 centers in the U.S. and Europe, who will be randomized on a one-to-one basis for treatment with Endosense’s force-sensing TactiCath or a catheter approved by the FDA for paroxysmal AF.
The study’s primary effectiveness endpoint will measure acute procedural success as well as chronic freedom from symptomatic AF, atrial tachycardia and atrial flutter at 12 months. The safety endpoint will report the incidence of device-related serious adverse events.
In addition, TOCCASTAR will assess the contribution of contact force information to procedural effectiveness during ablation compared to conventional radiofrequency irrigated catheters.