MedHub AutocathFFR United States Validation Study
This observational study evaluated how well the AutocathFFR software measures fractional flow reserve (FFR) from coronary angiogram images. AutocathFFR runs on standard two-dimensional (2D) angiograms taken during cardiac catheterization. Researchers compared its results to invasive FFR, the gold standard.
The main questions were:
A vessel is scored "positive" when FFR ≤ 0.80 and "negative" when FFR > 0.80. Researchers retrospectively analyzed consecutive angiograms from 4 sites in the United States. 278 patients (300 vessels) were analyzed with the AutocathFFR software, and 277 patients (297 vessels) completed AutocathFFR analysis. Participants were adults with stable angina, unstable angina, or non-ST-elevation myocardial infarction (NSTEMI) who underwent invasive coronary angiography and invasive FFR.
Post Marketing Clinical Trial to Demonstrate the Performance of the MedHub AutocathFFR Device.
Evaluation of a Novel Non-Invasive Automated Fractional Flow Reserve Software System in Patients With Coronary Artery Disease
Pivotal, Single-arm Clinical Trial to Assess the Efficacy and Safety of the MedHub AutocathFFR Software Device
Validation of a Predictive Model of Coronary Fractional Flow Reserve in Patients With Intermediate Coronary Stenosis