A Prospective Study of Fractional Flow Reserve Assessment of Intermediate Coronary Stenoses in Severe Aortic Stenosis
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Aortic Stenosis
- Coronary Artery Stenoses
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: A single group of patients with severe aortic stenosis and intermediate coronary stenoses will undergo coronary physiology assessment with iFR/FFR before and after transcatheter aortic valve replacement.Masking: None (Open Label)Primary Purpose: Diagnostic
Participation Requirements
- Age
- Between 20 years and 110 years
- Gender
- Both males and females
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 of fractional flow reserve (FFR) in patients with severe aortic stenosis (AS) and intermediate severi...
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 of fractional flow reserve (FFR) in patients with severe aortic stenosis (AS) and intermediate severity coronary stenoses, and the widely accepted cut-off value of 0.80 may not be applicable to this patient population. Coronary flow reserve is known to be attenuated under conditions of left ventricular hypertrophy and severe AS, with one study showing improvement in coronary flow reserve after aortic valve replacement. Left ventricular hypertrophy produces fixed resistance secondary to external compression of the coronary microcirculation. This potentially results in failure to achieve maximal hyperemia with adenosine and can lead to false negative FFR results. Neurohormonal influences in aortic stenosis can further attenuate vasodilator response and potentially result in false negative FFR values. Both of these conditions result in the potential deferral of lesions which may have been hemodynamically significant in the absence of severe AS. At present, there are no studies which have demonstrated validity of FFR measurement in patients with severe AS. Here, the investigators propose a prospective study of iFR/FFR in patients with AS and indeterminate coronary lesions undergoing TAVR to understand the hemodynamic consequences of AS on iFR/FFR. The investigators hypothesize that iFR/FFR values will be consistently and significantly higher pre-TAVR in comparison with post-TAVR for the same lesions.
Tracking Information
- NCT #
- NCT03442400
- Collaborators
- Volcano Corporation
- Investigators
- Principal Investigator: Samir R Kapadia, MD The Cleveland Clinic
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