Study Initiated to Evaluate Efficacy of Esophageal Cooling During RF Ablation Procedures

Heart Rhythm Clinical and Research Solutions (HRCRS) and the Real World Evidence (RWE) Consortium have enrolled the first patient in the REView of ProcEdural FactoRs and Outcomes after Atrial Fibrillation Ablation with Active Esophageal COOLing (EVERCOOL AF) study. The trial is part of a multi-center observational study evaluating the impact of proactive esophageal cooling on patient outcome, throughput, and experience in high-volume centers.

“This evaluation will help us confirm the benefits of esophageal cooling beyond safety alone, including shorter procedure times, reduced fluoroscopy requirements, greater hospital savings, and improved long-term freedom from arrhythmia,” HRCRS President and electrophysiologist Jose Osorio, M.D., said. “Our members are enthusiastic about the potential impact the ensoETM will have on patient outcomes and operational efficiencies.”
 
The RWE consortium consists of about 50 US high-volume electrophysiology centers that perform procedures such as cardiac radiofrequency ablation to treat atrial fibrillation. Participating members will collect and report data on ensoETM usage to HRCRS for analysis. HRCRS is a contract research organization specializing in connecting industry clients to cardiac electrophysiologists and providing infrastructural support to conduct research.
  
“Our lab has published studies showing a 30 percent reduction in procedure time and a 14 percent improvement in long-term efficacy when using ensoETM,” noted Mark Metzl, M.D., section chief, Cardiac Electrophysiology at Endeavor Health (formerly NorthShore University Health System), and one of the two co-principal study investigators. “This multi-center study will help us to further quantify effects in a wider range of practice across the U.S.”
 
Sites and investigators participating in the EVERCOOL AF study include: Alex Costea, M.D., Clinical Cardiac Electrophysiology, The Christ Hospital, Physicians – Heart & Vascular, Cincinnati, OH; Joshua Silverstein, M.D., Allegheny General Hospital, Pittsburgh, Pa.; Parin Patel, M.D., Ascension St. Vincent, Indianapolis, Ind.; Matthew Singleton, M.D., WellSpan York Hospital, York, Pa.; Huy Phan, M.D., Ph.D., Valley Heart Rhythm Specialists, Chandler, Ariz.; and Javier Sanchez, M.D., Texas Cardiac Arrhythmia Institute, Dallas, Texas.

“I’ve been using proactive esophageal cooling for over two years now, and have been pleased with the safety and procedural efficiency that it offers, which in turn has increased our lab throughput to enable the treatment of more patients. I expect this new study will further quantify our experience,” stated co-principal investigator David K. Singh, M.D., director of the Center for Heart Rhythm Disorders at The Queen’s Heart Institute and associate professor of Medicine at the University of Hawai’i’s John A. Burns School of Medicine. 
 
Attune received U.S. Food and Drug Administration De Novo marketing authorization for the ensoETM last fall and has distributed over 70,000 devices to more than 200 hospitals and electrophysiology labs.
 
Now part of Haemonetics, Attune Medical is the pioneer of the ensoETM, a single-use thermal regulating device that is placed in the esophagus (similar to a standard orogastric tube) and connected to an external heat exchange unit, creating a closed-loop system for proactive controlled temperature management and reduction of the likelihood of ablation-related esophageal injury resulting from radiofrequency cardiac ablation procedures.