CardioFocus, the developer of the HeartLight endoscopic ablation system for the treatment of atrial fibrillation, announced on 25 June 2013 that its HeartLight technology is the focus of a multicentre European clinical study for the treatment of drug-refractory persistent atrial fibrilliaton.
The study, taking place at five centres in Germany and the Czech Republic, according to a press release, will be the first to prospectively assess pulmonary vein isolation with balloon ablation catheters in a persistent atrial fibrillation patient population. The first three patients were enrolled this month at Cardioangiologisches Centrum Bethanien (CBB) in Frankfurt, Germany.
Boris Schmidt, CCB and principal investigator of the trial, said, “The HeartLight system has been used with notable clinical success in the treatment of paroxysmal atrial fibrillation, with multicentre remapping studies demonstrating more durable pulmonary vein isolation than achieved with alternative catheter systems. Previous research with radiofrequency ablation technology also suggests that pulmonary vein isolation may also be an effective initial treatment for persistent atrial fibrillation, 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 atrial fibrillation treatment.”
The prospective trial is expected to enrol and randomise 150 patients with drug-refractory persistent atrial fibrillation (episode duration of >7 days and
The aim of the study is to assess the safety and efficacy of pulmonary vein isolation using HeartLight in comparison to radiofrequency ablation, as the role of balloon catheters in the treatment of persistent atrial fibrillation remains undefined. The trial is expected to complete enrolment 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 visualisation capabilities and unique laser energy source; this new study will assess the value of achieving durable pulmonary vein isolation in this challenging-to-treat population.”
HeartLight, according to the company release, is the first catheter ablation system to incorporate an endoscope for direct visualisation of the pulmonary veins. 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 for more efficient and precise ablation.
The HeartLight technique is used as an index procedure for the treatment of paroxysmal atrial fibrillaton at centres 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 USA, which is nearing the conclusion of the enrolment phase.
The HeartLight system is commercially available at institutions throughout Europe and in Australia. The device is investigational in the USA.