The purpose of this multicenter study is to assess the impact of SSO2 treatment on clinical outcomes and left ventricular function in patients following acute ST-segment elevation myocardial infarction (STEMI).
The TherOx® Downstream® System, which is approved for use in the United States (US) by the Food and Drug Administration (FDA) under P170027. The TherOx® Downstream® System consists of three primary components. These include a hardware device called the TherOx Downstream System ("console"), a single-use disposable device called the TherOx Downstream Cartridge ("cartridge") and a 5 French, commercially available qualified SSO2 infusion coronary delivery catheter ("delivery catheter"). This is a multicenter, retrospective case-control study which will collect data from all STEMI patients who received SSO2 treatment at participating centers, along with up to 3 matched control patients who did not receive SSO2 treatment.
Study Type
OBSERVATIONAL
Enrollment
403
Baptist Hospital of Miami, Inc and Its Miami Cardiac and Vascular Institute
Miami, Florida, United States
NCH Healthcare System
Naples, Florida, United States
Oakwood Healthcare, Inc
Dearborn, Michigan, United States
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, United States
Change of Left Ventricular Ejection Fraction
Between group comparison
Time frame: Baseline to 3 months
Rate of Cardiovascular related Hospitalizations
Between group comparison
Time frame: Through study completion, an average of 1 year
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Northwell Health, Inc
Great Neck, New York, United States
OhioHealth Research Institute
Columbus, Ohio, United States
Avita Health
Galion, Ohio, United States
St. Mary's Medical Center
Huntington, West Virginia, United States