Heart Rhythm Clinical and Research Solutions (HRCRS) and the Real World Evidence (RWE) Consortium have enrolled the first patient in the EVERCOOL AF study, a multicentre observational study evaluating the impact of proactive oesophageal cooling on patient outcome, throughput, and experience in high-volume centres.
The RWE consortium consists of 50 US high-volume electrophysiology centers that perform procedures such as cardiac radiofrequency (RF) ablation for the treatment of atrial fibrillation (AF). Participating members collect and report data on the usage of ensoETM (Attune Medical) to HRCRS for analysis in the clinical study.
HRCRS is a Contract Research Organization (CRO) specialising 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 oesophageal cooling beyond safety alone, including shorter procedure times, reduced fluoroscopy requirements, greater hospital savings, and improved long-term freedom from arrhythmia,” commented Jose Osorio (HCA Florida Miami, Miami, USA), 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% reduction in procedure time and a 14% improvement in long-term efficacy when using ensoETM,” said Mark Metzl (Endeavor Health, Skokie, USA) one of the two co-principal Investigators of the study. “This important multicentre study will help us to further quantify effects in a wider range of practice across the USA.”
Co-principal investigator David Singh (The Queen’s Heart Institute, Honolulu, USA) said: “I’ve been using proactive oesophageal 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.”
Attune received de novo marketing authorisation from the US Food and Drug Administration (FDA) for use of its ensoETM to reduce the likelihood of ablation-related oesophageal 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.
