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FORTUNA(Evaluation of Fractional Flow Reserve Calculated by Computed Tomography Coronary Angiography in Patients undergoing Transcatheter Aortic Valve Replacement)

FORTUNA(Evaluation of Fractional Flow Reserve Calculated by Computed Tomography Coronary Angiography in Patients undergoing Transcatheter Aortic Valve Replacement) - FORTUNA

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000033357
Enrollment
25
Registered
2018-09-01
Start date
2018-10-25
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

severe aortic stenosis

Interventions

The intervention tested in this study is to measure FFR using a guide wire that is capable of sensing pressure following TAVR. After the pressure gradient across the aortic valve is relieved by TAVR,

Sponsors

Division of Cardiovascular Medicine, Department of Internal Medicine, Graduate School of Medicine, Kobe University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients who meet all the following criteria will be included in the study: 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 PCI following TAVR 2)Patients aged 20 years or older at the time of diagnosis

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
A cut-off value for FFRct that can estimate FFR of <0.80 in patients with severe AS

Secondary

MeasureTime frame
(1)A cut-off value for pre-TAVR iFR that can estimate FFR of <0.80 in patients with severe AS (2)Regression and correlation coefficient of FFRct before TAVR and after TAVR (3)Regression and correlation coefficient of iFR before TAVR and after TAVR (4)Stenosis degree in coronary angiography before TAVR predicting FFR: <0.80 in severe AS patients

Countries

Japan

Contacts

Public ContactRyo Takeshige

Graduate School of Medicine, Kobe University Division of Cardiovascular Medicine, Department of Internal Medicine

takeshige.kobe@gmail.com078-382-5846

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026