The first patient has been enrolled and treated in the HeartLight EAS US pivotal trial, designed to evaluate the safety and efficacy of the HeartLight Endoscopic Ablation System (EAS) (CardioFocus) in treating symptomatic atrial fibrillation by creating electrical isolation of the pulmonary veins.
According to a company release, the 48-year-old patient had suffered with paroxysmal atrial fibrillation for three years and underwent successful pulmonary vein isolation at Mount Sinai School of Medicine in New York, USA. All four pulmonary veins were isolated on the very first attempt using only visual guidance during the approximately two-hour procedure.
The Food and Drug Administration (FDA) granted Investigational Device Exemption (IDE) approval for HeartLight EAS in December 2011, enabling the initiation of the trial.
The HeartLight EAS is the first catheter ablation system to incorporate an endoscope for direct visualisation of a beating heart, in real time and without radiation. It includes a compliant, dynamically adjustable balloon catheter designed for improved contact with the pulmonary vein ostium (opening) irrespective of individual patient anatomy, and utilises laser energy for more efficient, durable and precise ablation.
“The visually-guided HeartLight EAS is unique in cardiac catheter ablation and offers a promising new treatment option for drug-refractory atrial fibrillation. For the first time, physicians can see within a beating heart to more precisely deliver ablation energy and confirm contiguous lesion placement, which we believe may lead to improved patient outcomes,” said Vivek Y Reddy, Mount Sinai School of Medicine, and principal investigator of the trial. “The system has been used with great clinical success in Europe, with recent published data supporting the high rate of both acute and durable pulmonary vein isolation enabled by the device. We are optimistic that we will be able to achieve similar results in this trial.”
The prospective trial will randomise the HeartLight EAS against the NaviStar Thermocool Catheter (Biosense Webster). Only a single ablation procedure with the HeartLight EAS will be permitted, while repeat ablation may be performed with the Thermocool system. In total, the trial will randomise an estimated 350 patients at up to 25 sites in the USA and follow them for one year post-procedure.
The primary outcome measures will assess both safety and freedom from documented, symptomatic atrial fibrillation. The results will be used as the basis for CardioFocus’s Premarket Approval (PMA) filing with the FDA for HeartLight EAS. In addition to Mount Sinai, Texas Cardiac Arrhythmia Research Foundation in Austin, Texas is also currently enrolling patients.
“Catheter ablation offers a minimally invasive, interventional treatment option for millions of people with drug-refractory atrial fibrillation. However, traditional systems have demonstrated limited durable pulmonary vein isolation and compromised long-term efficacy after only a single procedure,” said Andrea Natale, Texas Cardiac Arrhythmia Research Foundation and trial co-principal investigator. “We are excited to be involved in evaluating this ground-breaking catheter ablation option that has the potential to improve upon the current standard of care.”
The HeartLight EAS technology is currently available at sites throughout Europe for the treatment of atrial fibrillation. More information on the trial is available at https://clinicaltrials.gov/show/NCT01456000.