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

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ClinicalTrials.gov Identifier: NCT03665389
Recruitment Status : Not yet recruiting
First Posted : September 11, 2018
Last Update Posted : September 13, 2018
Sponsor:
Information provided by (Responsible Party):
Hiromasa Otake, Kobe University

Tracking Information
First Submitted Date  ICMJE August 30, 2018
First Posted Date  ICMJE September 11, 2018
Last Update Posted Date September 13, 2018
Estimated Study Start Date  ICMJE September 13, 2018
Estimated Primary Completion Date March 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 9, 2018)
FFRct before TAVR [ Time Frame: Baseline ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03665389 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 9, 2018)
  • FFRct after TAVR [ Time Frame: Up to 4 weeks ]
  • FFR after TAVR [ Time Frame: Up to 4 weeks ]
  • iFR before TAVR and after TAVR [ Time Frame: Baseline and up to 4 weeks ]
  • Stenosis degree in coronary angiography performed before TAVR [ Time Frame: Baseline ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Fractional Flow Reserve Calculated by Computed Tomography Coronary Angiography in Patients Undergoing TAVR
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Aortic Valve Stenosis
  • Coronary Artery Disease
Intervention  ICMJE Device: iFR / FFR measurement
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.
Study Arms  ICMJE Single Arm
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: Device: iFR / FFR measurement
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: September 9, 2018)
25
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 31, 2022
Estimated Primary Completion Date March 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03665389
Other Study ID Numbers  ICMJE 300028
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hiromasa Otake, Kobe University
Study Sponsor  ICMJE Kobe University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Kobe University
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP