NCT03665389

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2018

Longer than P75 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 30, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 11, 2018

Completed
2 days until next milestone

Study Start

First participant enrolled

September 13, 2018

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2022

Completed
Last Updated

September 13, 2018

Status Verified

September 1, 2018

Enrollment Period

3.5 years

First QC Date

August 30, 2018

Last Update Submit

September 12, 2018

Conditions

Aortic Valve StenosisCoronary Artery Disease

Keywords

FFRctaortic stenosis

Outcome Measures

Primary Outcomes (1)

  • FFRct before TAVR

    Baseline

Secondary Outcomes (4)

  • FFRct after TAVR

    Up to 4 weeks

  • FFR after TAVR

    Up to 4 weeks

  • iFR before TAVR and after TAVR

    Baseline and up to 4 weeks

  • Stenosis degree in coronary angiography performed before TAVR

    Baseline

Study Arms (1)

Single Arm

OTHER

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.

Device: iFR / FFR measurement

Interventions

iFR / FFR measurementDEVICE

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.

Single Arm

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Aortic Valve StenosisCoronary Artery Disease

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow ObstructionCoronary DiseaseMyocardial IschemiaArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Lecturer

Study Record Dates

First Submitted

August 30, 2018

First Posted

September 11, 2018

Study Start

September 13, 2018

Primary Completion

March 31, 2022

Study Completion

March 31, 2022

Last Updated

September 13, 2018

Record last verified: 2018-09