Chelmsford, Massachusetts-based Zoll’s trial will evaluate TherOx for treating the most severe form of heart attack: left anterior descending (LAD) ST-elevation myocardial infarction (STEMI). TherOx is an FDA-approved therapy shown to reduce the size of damaged tissue following percutaneous coronary intervention (PCI).
Zoll’s SSO2 therapy delivers a high concentration of dissolved oxygen directly to damaged heart muscle immediately after stenting. TherOx is indicated for patients who suffer LAD STEMI treated within six hours of symptom onset.
The first patient was treated with SSO2 therapy at WakeMed Health & Hospitals in North Carolina. AMIHOT III will further validate the benefits of TherOx over standard of care along. Aside from safety and effectiveness, additional endpoints include incidence of microvascular obstruction (MVO), and outcomes measures such as heart failure readmissions and quality-of-life measures.
“WakeMed strives to be on the cutting edge of cardiovascular care, and I am excited that our team has enrolled the first AMIHOT III patient in this study to further confirm SSO2 therapy’s benefits over standard of care in the treatment of severe heart attacks,” said Dr. Frances Wood, interventional cardiologist at WakeMed. “Based on our experience with the IC-HOT trial that helped SSO2 achieve FDA approval, we believe this therapy will have a strong impact in improving outcomes and reducing mortality for heart attack patients.”
Dr. James Blankenship of the University of New Mexico is the principal investigator. Zoll said the study will randomize 434 patients across the U.S. and Europe.
“With SSO2 therapy, Zoll is expanding care for LAD STEMI patients,” said Christopher Barnabas, President of Zoll circulation. “Previous data serve as a strong indication that we will observe short- and long-term outcome improvements such as reduced incidence of heart failure and mortality in these high-risk patients.”