CardioFocus, Inc., developer of the HeartLight® Endoscopic Ablation System for the treatment of atrial fibrillation (AF), announces that its HeartLight technology is the focus of a multicenter European clinical study for the treatment of drug-refractory persistent AF. The study, taking place at five centers in Germany and the Czech Republic, will be the first to prospectively assess pulmonary vein isolation (PVI) with balloon ablation catheters in a persistent AF patient population. The first three patients were enrolled this month at Cardioangiologisches Centrum Bethanien (CCB) in Frankfurt, Germany.
Boris Schmidt, MD, of CCB and Principal Investigator of the trial, said, "The HeartLight System has been used with notable clinical success in the treatment of paroxysmal AF, with multicenter remapping studies demonstrating more durable pulmonary vein isolation than achieved with alternative catheter systems. Previous research with radiofrequency ablation technology also suggests that PVI may also be an effective initial treatment for persistent AF, but due to high rates of reconnection, patients often require more than one intervention. With this study, we hope to establish initial data around the use of balloon catheters for this clinical application and lay the groundwork for further study of HeartLight in advanced AF treatment."
The prospective trial will enroll and randomize 150 patients with drug-refractory persistent AF (episode duration of >7 days and <1 year) to receive catheter ablation with either HeartLight or a commercial irrigated radiofrequency (RF) catheter and electroanatomical mapping. The aim of the study is to assess the safety and efficacy of PVI using HeartLight in comparison to RF ablation, as the role of balloon catheters in the treatment of persistent AF remains undefined. The trial is expected to complete enrollment by May 2014 and will follow patients for one year post procedure.
Stephen Sagon, President of CardioFocus, said, "We are excited that our technology will be used in this groundbreaking study. European clinical experience to date has confirmed the clinical advantages of HeartLight's direct visualization capabilities and unique laser energy source; this new study will assess the value of achieving durable PVI in this challenging-to-treat population."
HeartLight is the first catheter ablation system to incorporate an endoscope for direct visualization of the pulmonary veins. It includes a compliant balloon catheter designed for improved contact with the PV ostium (opening) irrespective of individual patient anatomy, and a laser energy source for more efficient and precise ablation.
The HeartLight technique is a widely used index procedure for the treatment of paroxysmal AF at centers throughout Europe, where data has demonstrated an 83% single procedure chronic success rate with the technology. HeartLight is also the focus of an ongoing pivotal trial in the U.S., which is nearing the conclusion of the enrollment phase.