Evaluation of Fractional Flow Reserve Calculated by Computed Tomography Coronary Angiography in Patients Undergoing TAVR (FORTUNA)
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 Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
OTHER: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
FFRct before TAVR
Time Frame: Baseline
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
FFRct after TAVR
Time Frame: Up to 4 weeks
|
Up to 4 weeks
|
|
FFR after TAVR
Time Frame: Up to 4 weeks
|
Up to 4 weeks
|
|
iFR before TAVR and after TAVR
Time Frame: Baseline and up to 4 weeks
|
Baseline and up to 4 weeks
|
|
Stenosis degree in coronary angiography performed before TAVR
Time Frame: Baseline
|
Baseline
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 300028
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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