Status:
TERMINATED
A Prospective Study of Fractional Flow Reserve Assessment of Intermediate Coronary Stenoses in Severe Aortic Stenosis
Lead Sponsor:
The Cleveland Clinic
Collaborating Sponsors:
Volcano Corporation
Conditions:
Coronary Artery Stenoses
Aortic Stenosis
Eligibility:
All Genders
20-110 years
Phase:
NA
Brief Summary
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 investiga...
Detailed Description
The purpose of the study is to determine whether iFR assessment gives a valid assessment of coronary hemodynamics in patients with severe aortic stenosis. Several factors confound the interpretation ...
Eligibility Criteria
Inclusion
- All patients who have coronary stenoses between 40-70% severity and who have severe aortic stenosis undergoing TAVR work-up.
Exclusion
- 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.
Key Trial Info
Start Date :
February 14 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 10 2021
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT03442400
Start Date
February 14 2018
End Date
August 10 2021
Last Update
January 5 2023
Active Locations (1)
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1
The Cleveland Clinic
Cleveland, Ohio, United States, 44195