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

NCT ID: NCT03442400

Last Updated: 2023-01-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-14
• Study Completion Date: 2021-08-10

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 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.

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.

Conditions

Coronary Artery Stenoses; Aortic Stenosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

FFR/iFR arm

Volcano iFR/FFR Verrata Plus coronary pressure/flow wire

Group Type: EXPERIMENTAL

Volcano iFR/FFR Verrata Plus coronary pressure/flow wire

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 110 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Volcano Corporation

INDUSTRY

Sponsor Role: collaborator

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Samir R Kapadia, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

The Cleveland Clinic

Cleveland, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

IRB 17-695

Identifier Type: -

Identifier Source: org_study_id