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

NCT03665389 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2018-09-13

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Kobe University

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-13
Primary Completion
2022-03-31
Completion
2022-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03665389 on ClinicalTrials.gov