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

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.

Study Overview

• Status: Terminated
• Conditions: Aortic Stenosis; Coronary Artery Stenoses
• Intervention / Treatment: Device: Volcano iFR/FFR Verrata Plus coronary pressure/flow wire

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 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.

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • The Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 110 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FFR/iFR arm; Volcano iFR/FFR Verrata Plus coronary pressure/flow wire	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Collaborators: Volcano Corporation
• Investigators: Principal Investigator: Samir R Kapadia, MD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2018
• Primary Completion (Actual): August 10, 2021
• Study Completion (Actual): August 10, 2021

Study Registration Dates

• First Submitted: February 6, 2018
• First Submitted That Met QC Criteria: February 15, 2018
• First Posted (Actual): February 22, 2018

Study Record Updates

• Last Update Posted (Actual): January 5, 2023
• Last Update Submitted That Met QC Criteria: December 13, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Aortic Stenosis; Coronary Artery Stenoses
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pathological Conditions, Anatomical; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Coronary Disease; Aortic Valve Stenosis; Constriction, Pathologic; Coronary Stenosis
• Other Study ID Numbers: IRB 17-695

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No