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

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ClinicalTrials.gov Identifier: NCT03442400
Recruitment Status : Recruiting
First Posted : February 22, 2018
Last Update Posted : July 23, 2019
Sponsor:
Collaborator:
Volcano Corporation
Information provided by (Responsible Party):
Samir Kapadia, The Cleveland Clinic

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Stenoses Aortic Stenosis Device: Volcano iFR/FFR Verrata Plus coronary pressure/flow wire Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Intervention 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
Official Title: A Prospective Study of Fractional Flow Reserve Assessment of Intermediate Coronary Stenoses in Severe Aortic Stenosis
Actual Study Start Date : February 14, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. iFR/FFR [ Time Frame: Immediately prior to transcatheter aortic valve replacement, during the index procedure ]
    Hemodynamic significance of a coronary stenosis

  2. Pd/Pa (ratio of the pressure distal to a coronary stenosis and the pressure in the aorta) [ Time Frame: Immediately prior to transcatheter aortic valve replacement, during the index procedure ]
    Hemodynamic significance of a coronary stenosis

  3. iFR/FFR [ Time Frame: Immediately after transcatheter aortic valve replacement, during the index procedure ]
    Hemodynamic significance of a coronary stenosis

  4. Pd/Pa (ratio of the pressure distal to a coronary stenosis and the pressure in the aorta) [ Time Frame: Immediately after transcatheter aortic valve replacement, during the index procedure ]
    Hemodynamic significance of a coronary stenosis



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Ages Eligible for Study:   20 Years to 110 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03442400


Contacts
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Contact: Jayendrakumar S Patel, MD 2169734728 patelj2@ccf.org

Locations
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United States, Ohio
The Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Jayendrakumar S Patel, MD    216-973-4728    patelj2@ccf.org   
Sponsors and Collaborators
The Cleveland Clinic
Volcano Corporation
Investigators
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Principal Investigator: Samir R Kapadia, MD The Cleveland Clinic

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Responsible Party: Samir Kapadia, Director, Sones Catheterization Laboratories, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT03442400     History of Changes
Other Study ID Numbers: IRB 17-695
First Posted: February 22, 2018    Key Record Dates
Last Update Posted: July 23, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Samir Kapadia, The Cleveland Clinic:
Coronary Artery Stenoses
Aortic Stenosis

Additional relevant MeSH terms:
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Aortic Valve Stenosis
Coronary Stenosis
Constriction, Pathologic
Pathological Conditions, Anatomical
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction
Coronary Disease
Myocardial Ischemia
Vascular Diseases