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Validation of the MedHub AutocathFFR Software Device for Non-Invasive Fractional Flow Reserve (FFR)
Sponsor: Medhub Ltd.
Summary
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: * What is the sensitivity of AutocathFFR per vessel compared to invasive FFR? * What is the specificity of AutocathFFR per vessel compared to invasive FFR? 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.
Official title: MedHub AutocathFFR United States Validation Study
Key Details
Gender
All
Age Range
23 Years - Any
Study Type
OBSERVATIONAL
Enrollment
277
Start Date
2025-11-04
Completion Date
2026-06-29
Last Updated
2026-08-13
Healthy Volunteers
No
Interventions
MedHub AutocathFFR
MedHub AutocathFFR is a software device for the analysis of previously acquired angiography data in Digital Imaging and Communications in Medicine (DICOM) format. The AutocathFFR value is computed from standard 2D angiography images, taken from two different views, retrieved from the C-arm angiography system. The FFR value is calculated using a machine-learning and computer vision algorithm. The result is intended to support the functional evaluation of coronary artery disease.
Locations (4)
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
Emory University Hospital
Atlanta, Georgia, United States
Northeast Georgia Medical Center
Gainesville, Georgia, United States
University of Virginia Health System
Charlottesville, Virginia, United States