CHICAGO--(BUSINESS WIRE)--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 study 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.
The RWE consortium consists of approximately 50 US high-volume electrophysiology centers that perform procedures such as cardiac radiofrequency ablation for the treatment of atrial fibrillation. Participating members collect and report data on the usage of ensoETM to HRCRS for analysis in the clinical study. HRCRS is a Contract Research Organization (CRO) specializing in connecting industry clients to the right cardiac electrophysiologists and providing infrastructural support to conduct the most productive, efficient, and cost-effective research possible.
“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,” commented Jose Osorio, MD, a leading electrophysiologist and President of HRCRS. “Our members are enthusiastic about the potential impact the ensoETM will have on patient outcomes and operational efficiencies.”
“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 one of the two Co-Principal Investigators of the study, Mark Metzl, MD, FHRS, Section Chief, Cardiac Electrophysiology at Endeavor Health (formerly NorthShore University Health System). “This important multi-center study will help us to further quantify effects in a wider range of practice across the U.S.”
Co-Principal Investigator David K. Singh, MD, FHRS, Director of the Center for Heart Rhythm Disorders at The Queen's Heart Institute, is also an Associate Professor of Medicine at the University of Hawai’i's John A. Burns School of Medicine. Dr. Singh noted “I’ve been using proactive esophageal cooling for over two years now, and have been quite 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.”
Sites and investigators participating in the EVERCOOL AF study include: Alex Costea, MD, FHRS, Clinical Cardiac Electrophysiology, The Christ Hospital, Physicians - Heart & Vascular, Cincinnati, OH; Joshua Silverstein, MD, FHRS, Allegheny General Hospital, Pittsburgh, PA; Parin Patel, MD, FHRS, Ascension St. Vincent, Indianapolis, IN; Matthew Singleton, MD, MBE, MHS, MSc, FHRS, WellSpan York Hospital, York, PA; Huy Phan, MD, PhD, FHRS, Valley Heart Rhythm Specialists, Chandler, AZ; and Javier Sanchez, MD, FHRS, Texas Cardiac Arrhythmia Institute, Dallas, TX.
Attune received De Novo marketing authorization from the US FDA for use of its ensoETM to reduce the likelihood of ablation-related esophageal injury resulting from radiofrequency cardiac ablation procedures in September 2023, and has distributed over 70,000 devices to more than 200 hospitals and electrophysiology labs.
About Attune Medical® and ensoETM®
Attune Medical, now a part of Haemonetics, 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.
Research mentioned in this press release was supported by the National Heart, Lung, and Blood Institute of the National Institutes of Health under Award Number R44HL158375. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
