Enrollment Underway in Attune Medical’s IMPACT II Study

Attune Medical is actively enrolling patients in the Improving Oesophageal Protection During Catheter Ablation for Atrial Fibrillation (IMPACT II) Study, which will evaluate use of the ensoETM in cardiac radiofrequency ablation procedures. Trial data will be used to expand the ensoETM’s intended use to include reduction of esophageal thermal injury during cardiac radiofrequency ablation procedures.
 
Mark Gallagher, M.D., consultant electrophysiologist at St. George’s Hospital in London, is leading this multi-national, multi-center randomized controlled trial. Gallagher also led the IMPACT single-center study that was published last year. “Having successfully completed our IMPACT single-center study, my colleagues and I are excited to continue the next phase of our work with this elegant technology,” commented Gallagher.
 
The study launched at St. George’s University Hospital in London, with four additional U.K. sites joining soon.
 
Attune Medical plans to submit an investigational device exemption application to the U.S. Food and Drug Administration (FDA) to begin enrolling sites in the United States under the leadership of Pasquale Santangeli, M.D., Ph.D., associate professor of Medicine at the Hospital of the University of Pennsylvania.
 
The study’s U.S. expansion is supported by a $3.8 million Small Business Innovation Research (SBIR) award from the National Heart, Lung, and Blood Institute of the National Institutes of Health.ⁱ
 
“Having led the pilot eCOOL-AF study of this technology, my team and I are eager to expand the research into this important area of electrophysiology,” said Dr. Santangeli.
 
Attune Medical’s ensoETM is 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 heat transfer to increase or decrease patient temperature. Its placement in the esophagus, with proximity to blood flow from the heart and great vessels, allows highly efficient heat transfer. Unlike surface warming devices, ensoETM‘s internal placement doesn‘t impede patient access during surgery and allows gastric decompression and administration of fluids and medications. The ensoETM device is used in critical care units, operating rooms, and emergency departments for the intentional modulation of patient core temperature and can be rapidly placed by most trained healthcare professionals. The ensoETM has been cleared by the FDA to control patient temperature but has not been approved to reduce thermal injury to the esophagus during radiofrequency cardiac ablation procedures.

The IMPACT II study is evaluating the ensoETM to determine whether using the esophageal space for temperature management could have the potential to decrease collateral thermal injury related to radiofrequency (RF) ablation for the treatment of atrial fibrillation. 
 
Reference
ⁱ Research reported in this publication 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.