CardioFocus, developer of the HeartLight endoscopic ablation system (EAS) for the treatment of atrial fibrillation (AF), has concluded enrollment of its US pivotal trial evaluating the HeartLight system, for the treatment of symptomatic paroxysmal AF.
The randomized, controlled trial completed enrollment of over 400 patients from 21 research sites across the US.
The two-arm study investigated the use of the endoscopically guided HeartLight catheter in comparison to ordinary radiofrequency ablation using the NaviStar THERMOCOOL catheter (Biosense Webster).
A single ablation procedure was conducted in the HeartLight arm, while a repeat ablation was permitted with the THERMOCOOL system.
The primary endpoints include an assessment of safety and an evaluation of efficacy, which is defined as freedom from documented, symptomatic AF at one year.
With these findings, CardioFocus plans to submit a premarket approval filing with the US Food and Drug Administration (FDA) for HeartLight EAS following the completion of follow-up.
The HeartLight system is CE marked and is commercially available for this indication in the European Union and Australia.
It is reportedly is the first catheter ablation system to incorporate an endoscope for direct visualization of the cardiac anatomy in a beating heart, in real time and without radiation.
It includes a compliant balloon catheter designed for improved contact with the pulmonary vein ostium (opening) irrespective of individual patient anatomy, and a laser energy source designed for more efficient, precise and durable ablation therapy.
CardioFocus regulatory and clinical affairs vice president and study director Burke Barrett noted completion of enrollment in this pivotal study is a significant milestone for the company and its technology, and the company anticipates having results ready for submission to the FDA shortly after the one year follow-up period.
"Our sincere thanks to the prominent investigators and medical centers involved in the trial for completing the enrollment phase of the study on time, while focusing on conducting a high-quality study," Barrett added.