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

Aortic Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03442400
• Other study ID #: IRB 17-695
• Status: Terminated
• Phase: N/A
• Start date: February 14, 2018
• Est. completion date: August 10, 2021

Study information

• Verified date: December 2022
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

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 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: August 10, 2021
• Est. primary completion date: August 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 110 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Stenosis
• Constriction, Pathologic
• Coronary Artery Stenoses
• Coronary Stenosis

Intervention

Device:
• Volcano iFR/FFR Verrata Plus coronary pressure/flow wire
We will measure the degree of flow-limitation of intermediate severity coronary steonses using the iFR/FFR Verrata Plus coronary pressure/flow wire before and after transcatheter aortic valve replacement.

Locations

Country	Name	City	State
United States	The Cleveland Clinic	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
The Cleveland Clinic	Volcano Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FFR Values Prior to Transcatheter Aortic Valve Replacement	Hemodynamic significance of a coronary stenosis by measuring FFR immediately prior to TAVR	Immediately prior to transcatheter aortic valve replacement, during the index procedure
Primary	FFR Values During the Transcatheter Aortic Valve Replacement (TAVR)	Hemodynamic significance of a coronary stenosis by measuring FFR immediately after TAVR	Immediately after transcatheter aortic valve replacement, during the index procedure