Medical device manufacturer CardioFocus will complete full patient enrolment in a US pivotal clinical trial of its catheter ablation system in 2013.
The 350 patient-based trial, which is evaluating the safety and efficacy of the company’s HeartLight catheter ablation system against the NaviStar Thermocool catheter (Biosense Webster) for treating atrial fibrillation (AF), has currently enrolled over 180 patients.
The CE-marked HeartLight system features an endoscope for direct visualisation of the beating heart, a laser energy source and a compliant balloon catheter.
Mt Sinai University Medical Centre electrophysiology laboratories director and trial co-principal investigator Vivek Reddy said a key challenge in the treatment of AF has been the durability of the intervention.
"In this trial, we are investigating whether the unique attributes of the HeartLight technology can impact both acute and chronic freedom from AF and offer a new option for treating this complex condition," Reddy added.
CardioFocus regulatory and clinical affairs vice president Burke Barrett said that achieving the enrolment milestone speaks to the clinical need for an advanced treatment for AF.
"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," Barrett added.
"We’re on track to conclude enrolment in 2013 and, after the one year follow-up period, will prepare the data for submission to the FDA."