CardioFocus HeartLight US pivotal trial on track for full enrolment in 2013


On 14 January 2013, CardioFocus, developer of the HeartLight Endoscopic Ablation System for the treatment of atrial fibrillation, announced that the US pivotal trial evaluating the safety and efficacy of the HeartLight system is approximately half enrolled. The study, initiated in 2012, is on track to complete enrolment this year. HeartLight is the first catheter ablation system to incorporate an endoscope for direct visualisation of the beating heart, a laser energy source and a compliant balloon catheter.

Burke Barrett, vice president of Regulatory & Clinical Affairs at CardioFocus, said, “Achieving this enrolment milestone speaks to the clinical need for an advanced treatment for atrial fibrillation, a condition that is only continuing to increase in prevalence. We are excited that so many prominent physicians across the country have joined the trial as investigators and believe in the promise of the technology for their patients. We are on track to conclude enrolment in 2013 and, after the one year follow-up period, will prepare the data for submission to the FDA.”

In the USA, approximately three million people suffer with atrial fibrillation. The HeartLight pivotal trial is randomising the HeartLight system against the ThermoCool Catheter (Biosense Webster), and will randomise an estimated 350 patients in this multicentre US trial. Currently, over 180 patients have been enrolled at 21 sites; the company expects to complete enrolment this year. The HeartLight system is CE marked and clinically available in Europe and Australia.

Vivek Y Reddy , Mt Sinai University Medical Center, New York, NY and co-principal investigator of the trial, said, “A key challenge in the treatment of atrial fibrillation has been the durability of the intervention, as historically, a large number of patients who undergo catheter ablation experience a recurrence of the arrhythmia within a year. In this trial, we are investigating whether the unique attributes of the HeartLight technology can impact both acute and chronic freedom from atrial fibrillation, and offer a new option for treating this complex condition.”