Velomedix has completed enrollment of the first patient in Velocity clinical study of its rapid therapeutic hypothermia system for treating acute myocardial infarction (AMIs or heart attacks).
Using a peritoneal-based approach, the Velomedix system circulates cold fluid in the peritoneal cavity and removes heat and cools patients to less than 35°C in fewer than 15 minutes.
During the company's previous studies, patients treated with therapeutic hypothermia have reduced the severity of ST segment elevation myocardial infarctions (STEMIs) when cooled to temperatures of less than 35°C prior to percutaneous coronary intervention (PCI).
The prospective, multi-center trial, which will enroll 60 awake patients with anterior STEMIs at multiple US and Canadian sites, will randomize them to receive either primary PCI or a combination of primary PCI and cooling to therapeutic temperatures before reperfusion.
The primary endpoint of the study is a composite of specific new-onset, serious adverse events during the first 30 days following treatment.
Infarct size, myocardial salvage, left ventricular volumes and left ventricular ejection fraction, assessed by cardiac magnetic resonance imaging, will be collected as part of several secondary endpoints.
Columbia University Medical Center / New York-Presbyterian Hospital cardiovascular research and education director and trial co-principal investigator Gregg Stones said, "Velomedix appears to have developed an ultrafast cooling technology that might be effective without significantly delaying reperfusion."