CardioFocus has presented its HeartLight US pivotal trial data at Heart Rhythm 2015. It was presented by co-principal investigator Dr. Vivek Y. Reddy, Professor of Medicine at the Mount Sinai School of Medicine.
Dr. Reddy revealed that the trial, which randomized CardioFocus’ HeartLight Endoscopic Ablation System one-to-one versus the Biosense Webster Thermocool catheter, met both primary efficacy and safety endpoints and demonstrated a low learning curve for physicians using the HeartLight System.
Trial results show that when performing a single ablation procedure using the HeartLight System, the majority of patients experienced freedom from paroxysmal AF at 12 months.
Moreover, the primary safety endpoint and the primary efficacy endpoint of freedom from AF at 12 months were satisfied for the pre-specified non-inferiority test as per the study design.
The study protocol permitted investigators to perform only a single pulmonary vein isolation (PVI) procedure using HeartLight. Investigators were able to use the control arm device for both PVI and other left atrial targets, with up to two control arm procedures allowed.
Dr. Reddy commented, "These results demonstrate that a group of physicians largely new to the HeartLight technique can equal their performance with the control arm device by using the HeartLight System.
Importantly, these results were obtained early in the HeartLight learning curve from veteran radiofrequency (RF) catheter ablation practitioners with extensive experience with the control arm device."
Andrea Natale MD, FACC, FHRS, FESC, Co-Principal Investigator of the HeartLight US Pivotal Trial and Executive Medical Director at the Texas Cardiac Arrhythmia Institute at St. David’s Medical Center, added, "In addition to the impressive findings, more than 90% of the study investigators had no substantial prior experience in the clinical usage of the HeartLight catheter."
The company plans to submit the pivotal clinical study results to the US Food and Drug Administration (FDA) in the near future as part of an ongoing modular PMA process.
These data from the 21-center randomized HeartLight US pivotal trial add to the large body of clinical evidence encompassing nearly two dozen independent studies conducted over the last several years in the European Union supporting the CardioFocus HeartLight Endoscopic Ablation System.
The HeartLight Endoscopic Ablation System is designed to provide physicians with a practical, easy-to-use treatment for AF with the ability to see within their patient’s heart, and for the first time, visually direct the application of laser energy to achieve durable pulmonary vein isolation.