CardioFocus has treated the first patient in the US pivotal trial intended to assess the safety and efficacy of the HeartLight endoscopic ablation system (EAS) in treating symptomatic atrial fibrillation (AF).
The prospective US trial will randomise around 350 patients to compare the HeartLight EAS with the NaviStar Thermocool catheter (Biosense Webster).
The HeartLight catheter ablation system features an endoscope for direct visualisation of a beating heart, in real time without any radiation, with an adjustable balloon catheter for providing improved contact with the PV ostium (opening) irrespective of the individual patient's anatomy. The primary outcome measures will evaluate both safety and freedom from documented, symptomatic atrial fibrillation.
Principal investigator of the trial Vivek Reddy said the visually-guided HeartLight EAS allows physicians to precisely deliver ablation energy and confirm contiguous lesion placement, leading to improved patient outcomes.
"The system has been used with great clinical success in Europe, with recent published data supporting the high rate of both acute and durable PV isolation enabled by the device. We are optimistic we will be able to achieve similar results in this trial," Reddy added.
Company president and CEO Stephen Sagon said they look forward to working with the prominent medical centres involved in the trial and anticipate demonstrating the clinical advantages of the HeartLight EAS visualisation capabilities, compliant balloon and unique energy source.
In December 2011, the Food and Drug Administration (FDA) granted Investigational Device Exemption (IDE) approval for HeartLight ablation system.
The results will be used as the basis for the company's premarket approval (PMA) filing with the FDA for HeartLight EAS.
Co-principal investigator of the trial Andrea Natale said catheter ablation offers a minimally invasive, interventional treatment option for people with drug-refractory AF. Currently, the HeartLight EAS technology is available at sites throughout Europe for the treatment of AF.