Actively Recruiting

Age: 18Years +
All Genders
NCT06659367

Dedinje FFR/QFR Registry

Led by Institute for Cardiovascular Diseases Dedinje · Updated on 2024-10-26

2500

Participants Needed

1

Research Sites

521 weeks

Total Duration

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AI-Summary

What this Trial Is About

Quantitative Flow Ratio (QFR) has shown good diagnostic performance against Fractional Flow Reserve (FFR) in several meta-analyses, comparable or even superior to nonhyperemic pressure ratios. However, the reproducibility of QFR is modest and there is high inter- and intra-observer variability even when fairly experienced but non-core lab operators (at least 150 QFR procedure experience) are performing the analysis. Although smaller studies have demonstrated that non-core analysis and even paramedical user analysis can have good correlation with FFR, the concern about the diagnostic performance of QFR in real-world clinical practice by inexperienced users remains. The primary objective of "Dedinje FFR/QFR Registry" is to determine the feasibility and diagnostic performance of QFR analysis by vendor-certified inexperienced medical users in a real-world setting using FFR as the gold standard. All patients \>18 years old who present to the Institute for Cardiovascular Diseases "Dedinje" and undergo a planned or ad hoc FFR procedure will be asked to participate in the registry. FFR procedure is performed according to the standardized institutional protocol. QFR analysis will be subsequently performed offline according to a standard operating procedure.

CONDITIONS

Official Title

Dedinje FFR/QFR Registry

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants must be older than 18 years
  • Underwent a clinically indicated Fractional Flow Reserve (FFR) procedure, either planned or ad hoc
Not Eligible

You will not qualify if you...

  • Declines to participate and provide informed consent

AI-Screening

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Trial Site Locations

Total: 1 location

1

Institute for Cardiovascular Diseases "Dedinje"

Belgrade, Serbia, 11040

Actively Recruiting

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Research Team

N

Natalija Odanovic, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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