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Evaluation of Fractional Flow Reserve Calculated by Computed Tomography Coronary Angiography in Patients Undergoing TAVR (FORTUNA)

Primary Purpose

Aortic Valve Stenosis, Coronary Artery Disease

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
iFR / FFR measurement
Sponsored by
Kobe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Aortic Valve Stenosis focused on measuring FFRct, aortic stenosis

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Among patients who have undergone cCTA prior to TAVR, those with moderate stenotic lesions (30 to <70%) or severe stenotic lesions on CT who are candidates for percutaneous coronary intervention (PCI) following TAVR
  2. Patients aged 20 years or older at the time of diagnosis

Exclusion Criteria:

Patients who meet any one of the following criteria will be excluded from this study:

  1. Patients who were implanted with metal stents in the left main trunk,
  2. Patients with stenosis of >30% in the left main trunk who were implanted with at least one metal stent in the vessel(s) of the left coronary circulation,
  3. Patients who were implanted with metal stents in at least 2 vessels of the coronary circulation,
  4. Patients who requested withdrawal of consent for participation in this research study after providing their consent,
  5. Patients who underwent coronary artery bypass surgery,
  6. Patients with coronary artery chronic total occlusion,
  7. Patients who developed acute myocardial infarction in the past 2 months,
  8. Patients whose cCTA was determined to be unreadable during its evaluation at the study site because of the presence of artifacts which were severe enough to cause problems with the angiogram,
  9. Patients who were judged by the principal investigator to be unsuitable for the study for other reasons

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Single Arm

    Arm Description

    Among patients who undergo TAVR at the kobe university hospital, those who are found to have moderate or severe stenosis on cCTA performed before surgery and judged to clinically require ischemia evaluation will be included in this study.

    Outcomes

    Primary Outcome Measures

    FFRct before TAVR

    Secondary Outcome Measures

    FFRct after TAVR
    FFR after TAVR
    iFR before TAVR and after TAVR
    Stenosis degree in coronary angiography performed before TAVR

    Full Information

    First Posted
    August 30, 2018
    Last Updated
    September 12, 2018
    Sponsor
    Kobe University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03665389
    Brief Title
    Evaluation of Fractional Flow Reserve Calculated by Computed Tomography Coronary Angiography in Patients Undergoing TAVR
    Acronym
    FORTUNA
    Official Title
    Evaluation of Fractional Flow Reserve Calculated by Computed Tomography Coronary Angiography in Patients Undergoing Transcatheter Aortic Valve Replacement（FORTUNA）: Single Center, Open-label, Exploratory, Prospective Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 13, 2018 (Anticipated)
    Primary Completion Date
    March 31, 2022 (Anticipated)
    Study Completion Date
    March 31, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Kobe University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The objective of this study is to evaluate the relationship between fractional flow reserve (FFR) derived from coronary computed tomography angiography (FFRct) before transcatheter aortic valve replacement (TAVR) and FFR after TAVR so as to investigate whether FFRct is useful for evaluating myocardial ischemia of severe AS. Furthermore, by measuring the instantaneous wave-free ratio (iFR) which is a physiological diagnostic method of coronary artery stenosis before and after TAVR and comparing iFR (iFR before and after TAVR) and FFR (FFR after TAVR) with FFRct (FFRct before and after TAVR), It also aims to deepen understanding of resting coronary artery physiology in aortic valve stenosis.
    Detailed Description
    This is a single-center, open-label, exploratory, prospective study. Among patients who undergo coronary computed tomography angiography (cCTA) prior to TAVR, those with moderate or severe stenotic lesions will be included in the study. Patients from whom consent is obtained following TAVR will be enrolled in the study. Among patients who undergo TAVR at the Kobe University Hospital from September 2018 to March 2022, those who are found to have moderate or severe stenosis on cCTA performed before surgery and judged to clinically require ischemia evaluation will be included in the study. At the time of pre-TAVR coronary angiogram, iFR (iFR before TAVR) will be measured. The cCTA data collected from patients whose consent is obtained following TAVR will be anonymized and sent to HeartFlow, Inc., where the FFRct（FFRct before TAVR) values will be calculated using their cardiovascular dynamics analysis program. FFR (FFR after TAVR) and iFR (iFR after TAVR) will be measured using a guide wire that is capable of sensing pressure after TAVR is performed. Furthermore, FFRct (FFRct after TAVR) is calculated from cCTA taken after TAVR.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Aortic Valve Stenosis, Coronary Artery Disease
    Keywords
    FFRct, aortic stenosis

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    25 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Single Arm
    Arm Type
    Other
    Arm Description
    Among patients who undergo TAVR at the kobe university hospital, those who are found to have moderate or severe stenosis on cCTA performed before surgery and judged to clinically require ischemia evaluation will be included in this study.
    Intervention Type
    Device
    Intervention Name(s)
    iFR / FFR measurement
    Intervention Description
    At the time of pre-TAVR coronary angiogram, iFR (iFR before TAVR) will be measured. The cCTA data collected from patients whose consent is obtained following TAVR will be anonymized and sent to HeartFlow, Inc., where the FFRct （FFRct before TAVR） values will be calculated using their cardiovascular dynamics analysis program. With the FFRct values blinded, FFR (FFR after TAVR) and iFR (iFR after TAVR) will be measured using a guide wire that is capable of sensing pressure after TAVR is performed. Furthermore, FFRct(FFRct after TAVR) is calculated from cCTA taken after TAVR.
    Primary Outcome Measure Information:
    Title
    FFRct before TAVR
    Time Frame
    Baseline
    Secondary Outcome Measure Information:
    Title
    FFRct after TAVR
    Time Frame
    Up to 4 weeks
    Title
    FFR after TAVR
    Time Frame
    Up to 4 weeks
    Title
    iFR before TAVR and after TAVR
    Time Frame
    Baseline and up to 4 weeks
    Title
    Stenosis degree in coronary angiography performed before TAVR
    Time Frame
    Baseline

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Among patients who have undergone cCTA prior to TAVR, those with moderate stenotic lesions (30 to <70%) or severe stenotic lesions on CT who are candidates for percutaneous coronary intervention (PCI) following TAVR Patients aged 20 years or older at the time of diagnosis Exclusion Criteria: Patients who meet any one of the following criteria will be excluded from this study: Patients who were implanted with metal stents in the left main trunk, Patients with stenosis of >30% in the left main trunk who were implanted with at least one metal stent in the vessel(s) of the left coronary circulation, Patients who were implanted with metal stents in at least 2 vessels of the coronary circulation, Patients who requested withdrawal of consent for participation in this research study after providing their consent, Patients who underwent coronary artery bypass surgery, Patients with coronary artery chronic total occlusion, Patients who developed acute myocardial infarction in the past 2 months, Patients whose cCTA was determined to be unreadable during its evaluation at the study site because of the presence of artifacts which were severe enough to cause problems with the angiogram, Patients who were judged by the principal investigator to be unsuitable for the study for other reasons

    12. IPD Sharing Statement

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