Validation of the MedHub AutocathFFR Software Device for Non-Invasive Fractional Flow Reserve (FFR)
NCT: NCT07763769 · COMPLETED
Brief 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.
Frequently Asked Questions
What is Validation of the MedHub AutocathFFR Software Device for Non-Invasive Fractional Flow Reserve (FFR)?
Validation of the MedHub AutocathFFR Software Device for Non-Invasive Fractional Flow Reserve (FFR) is a clinical trial registered under NCT07763769. Current status: COMPLETED.
What is the status of NCT07763769?
The current status of NCT07763769 (Validation of the MedHub AutocathFFR Software Device for Non-Invasive Fractional Flow Reserve (FFR)) is: COMPLETED.
When did Validation of the MedHub AutocathFFR Software Device for Non-Invasive Fractional Flow Reserve (FFR) start?
Validation of the MedHub AutocathFFR Software Device for Non-Invasive Fractional Flow Reserve (FFR) started on 2025-11-04.
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Official Source
View on ClinicalTrials.gov →Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.