Endosense, a provider of cardiac technologies, has completed enrolling patients in its Toccastar clinical study.
The prospective, randomized, multi-center investigational device exemption trial, which enrolled 300 patients with symptomatic paroxysmal atrial fibrillation (AF), is designed to study the safety and effectiveness of the company's TactiCath force-sensing ablation catheter 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.
Toccastar clinical study principal investigator Vivek Reddy said, "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."
The company said it will use the results of Toccastar study to support a premarket approval application to the FDA in the third quarter of 2013.
