A Prospective Study of Fractional Flow Reserve Assessment of Intermediate Coronary Stenoses in Severe Aortic Stenosis

Stopped early · Not applicable

Conditions studied: Coronary Artery Stenoses, Aortic Stenosis

In brief

Coronary artery blockages can reduce blood flow to the heart muscle. Fractional flow reserve (iFR or FFR) assessment is an invasive tool used to determine how much blood flow is reduced. The investigators will perform iFR/FFR on all intermediate coronary stenoses using standard practice, immediately before (at the time of) transcatheter aortic valve replacement (TAVR) and after successful TAVR. The investigators will compare pre- and post-TAVR iFR/FFR values, and assess short-term outcomes. The investigators hypothesize that iFR/FFR values will be consistently and significantly higher pre-TAVR in comparison with post-TAVR for the same lesions.

Key facts

Study ID

NCT03442400

Run by

The Cleveland Clinic

People needed

5

Starts

2018-02-14

Expected to finish

2021-08-10

Last updated by the study team

2023-01-05

Who can join

Age: 20 and older, up to 110. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• All patients who have coronary stenoses between 40-70% severity and who have severe aortic stenosis undergoing TAVR work-up.

You may not qualify if…

• Patients with documented intraprocedural hemodynamic instability, shock, or major adverse event (myocardial infarction, aortic rupture/dissection, stroke, left ventricular perforation, cardiac arrest).
• Contraindication to adenosine, presence of cardiogenic shock, presence of acute coronary syndrome.

Where it is running

• The Cleveland Clinic — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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