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COMPLETED
NCT07763769

Validation of the MedHub AutocathFFR Software Device for Non-Invasive Fractional Flow Reserve (FFR)

Sponsor: Medhub Ltd.

View on ClinicalTrials.gov

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

DEVICE

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