On 15 October, CardioFocus announced that it has concluded enrolment of its US pivotal trial evaluating the HeartLight Endoscopic Ablation System for the treatment of symptomatic paroxysmal atrial fibrillation.
The randomised, controlled trial completed enrolment of over 400 patients from 21 research sites across the United States. 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). The company specifies that 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 atrial fibrillation at one year. With these findings, CardioFocus plans to submit a premarket approval application to the FDA for HeartLight 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.
Vivek Y Reddy, co-principal investigator and professor of Medicine at the Mount Sinai School of Medicine, New York, USA, said: “The HeartLight laser balloon system holds considerable promise for durable pulmonary vein isolation. With the potential FDA approval, the HeartLight would become a unique and valuable addition to the existing arsenal in the fight against atrial fibrillation.”
“Atrial fibrillation is the most common arrhythmia diagnosed, as well as the most frustrating to treat,” said Andrea Natale, co-principal investigator and executive medical director of Texas Cardiac Arrhythmia at St David’s Medical Center, Austin, USA. “While pulmonary vein isolation has the ability to effectively treat atrial fibrillation, many traditional catheter ablation devices are unsuccessful at achieving durable, gapless ablation due to their design limitations. However, the combined endoscope, balloon and laser in the HeartLight system could have the potential to improve the current standard of care for treating this complex condition.”
The HeartLight system visualises with and endoscope 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 irrespective of individual patient anatomy, and a laser energy source designed for more efficient, precise and durable ablation therapy.