Switzerland-based Endosense has completed enrolment in the TOCCASTAR investigational device exemption (IDE) study of its TactiCath force-sensing ablation catheter.
The prospective, randomised trial will evaluate the safety and effectiveness of the TactiCath force-sensing ablation catheter, based on 12-month follow-up data from the index procedure, in patients with symptomatic paroxysmal atrial fibrillation (AF).
Mount Sinai Medical Center Cardiac Arrhythmia Service director and TOCCASTAR principal investigator Dr Vivek Reddy said contact-force sensing in the context of a radiofrequency ablation catheter is an enhancement to the tools available to electrophysiologists treating AF.
"When complete, TOCCASTAR will provide the first randomised comparison of treatment safety and success between a conventional radiofrequency catheter and one with contact-force sensing capability," Reddy added.
"Through the use of this important diagnostic feature, we are gaining singular insights into the challenges and techniques that define optimal cardiac ablation therapy."
The multi-centre study randomised 300 patients on a one-to-one basis for treatment with the TactiCath or a control radiofrequency catheter.
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 is the primary effectiveness endpoint.
The safety endpoint is a non-inferiority comparison of early onset device-related serious adverse events.
A superiority comparison of procedural effectiveness related to the use of the contact-force sensor is the secondary endpoint of the study.
Endosense clinical affairs vice president Hendrik Lambert said, "We look forward to completing follow-up and reporting on the outcome of this landmark trial and to the potential of expanding commercialisation of the TactiCath worldwide."
The TOCCASTAR study results are expected to support a premarket approval application to the FDA in the third quarter of 2013, according to the company.