Endosense announced first patient enrolment in the Investigational Device Exemption (IDE) TOCCASTAR (Tacticath contact force ablation catheter study for atrial fibrillation) clinical study at Na Homolce Hospital, Prague, Czech Republic, by study investigator Petr Neuzil.
TOCCASTAR is a prospective, randomised, multicentre clinical trial designed to evaluate the effectiveness and safety of the TactiCath1 force-sensing ablation catheter for the treatment of symptomatic paroxysmal atrial fibrillation. Results of the study will be used to support a Premarket Approval Application (PMA) to the FDA for clearance of the TactiCath catheter and accompanying TactiSys system.
The clinical study will be conducted at up to 30 centres in the United States and Europe. Three hundred patients will be randomised on a one-to-one basis for treatment with Endosense’s force-sensing TactiCath or a catheter approved by the FDA for paroxysmal atrial fibrillation.
The study’s primary effectiveness endpoint will measure acute procedural success as well as chronic freedom from symptomatic atrial fibrillation, atrial tachycardia and atrial flutter at 12 months. The safety endpoint will report the incidence of device related serious adverse events. In addition, the research will assess the contribution of real time contact force information to procedural effectiveness during ablation compared to conventional radiofrequency irrigated catheters.
“This is a very exciting time for Endosense, as we embark on this critical step toward regulatory clearance for the TactiCath in the USA,” said Eric Le Royer, Endosense president and chief executive officer. “Based on the significant and growing foundation of clinical evidence we have built with the TactiCath contact force-sensing catheter, as well as our commercial success in Europe, we expect the results of TOCCASTAR to continue to demonstrate the great potential of contact force sensing to profoundly improve and expand the catheter ablation treatment of cardiac arrhythmias.”
Atrial fibrillation patients are typically treated with pharmaceutical drugs that are frequently ineffective and may cause side effects, or they undergo invasive surgery. TOCCASTAR will explore a new catheter ablation treatment option for patients who have symptomatic paroxysmal atrial fibrillation and who are resistant or intolerant to at least one Class I-IV anti-arrhythmic drug.
“The ability of physicians to control contact force during ablation procedures has long been a missing link in catheter ablation, and the consequence of this has been an historic trade off between procedure safety and effectiveness,” said Vivek Reddy, TOCCASTAR principal investigator and director of the Cardiac Arrhythmia Service, The Mount Sinai Medical Centre, New York. “TOCCASTAR is a landmark study in that its results may pave the way for contact force sensing to become the new standard of care in radiofrequency catheter ablation, a development that would finally address this issue and ultimately help improve safety, effectiveness and access to the procedure.”
