First patient receives treatment with cardio catheter ablation system

The first patient has enrolled and is being treated in a clinical trial for CardioFocus' (Marlborough, MA) HeartLight Endoscopic Ablation System (EAS) to evaluate the safety and efficacy of the technology in treating symptomatic atrial fibrillation (AF). The 48-year-old patient had suffered with paroxysmal AF for three years and underwent pulmonary vein (PV) isolation at Mount Sinai School of Medicine (New York, NY). All four PVs were isolated on the very first attempt using only visual guidance during the approximately two-hour procedure.

HeartLight EAS incorporates an endoscope for direct visualization of a beating heart, in real time and without radiation. It includes a compliant, dynamically adjustable balloon catheter designed for improved contact with the PV ostium (opening) irrespective of individual patient anatomy, and utilizes laser energy for efficient, durable, and precise ablation. The FDA granted Investigational Device Exemption (IDE) approval for the system in December 2011, enabling initiation of the trial.

For the first time, physicians can see within a beating heart to precisely deliver ablation energy and confirm contiguous lesion placement, which may lead to improved patient outcomes, says Vivek Y. Reddy, MD, of Mount Sinai School of Medicine, and principal investigator (PI) of the trial. 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, he says.

The prospective trial will randomize the HeartLight EAS against the NaviStar Thermocool Catheter (Biosense Webster; Diamond Bar, CA). Only a single ablation procedure with the HeartLight EAS will be permitted, while repeat ablation may be performed with the Thermocool system. In total, the trial will randomize an estimated 350 patients at up to 25 sites in the US, and follow them for one year post-procedure.

Primary outcome measures will assess both safety and freedom from documented, symptomatic AF. The results will be used as the basis for CardioFocus' Premarket Approval (PMA) filing with the FDA for HeartLight EAS. In addition to Mount Sinai, Texas Cardiac Arrhythmia Research Foundation (Austin, TX) is also currently enrolling patients.

The HeartLight EAS technology is currently available at sites throughout Europe for the treatment of AF. For more information, please visit http://clinicaltrials.gov/show/NCT01456000.

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