An observational study in Aortic Valve Stenosis and Heart Valve Diseases, sponsored by Kumamoto University. Completed at 1 site in Japan. Open to participants aged 20 Years to 100 Years. Per ClinicalTrials.gov, last updated 2018-10-02.
Sponsored by Kumamoto University · Observational
Transcatheter aortic valve implantation (TAVI) is well established, and can improve clinical outcomes of patients with severe aortic valve stenosis (AS) who are inoperable or have high surgical risk. Although the rates of periprocedural bleeding events are lower in TAVI compared to those in surgical aortic valve replacement, those in TAVI still remains high. In addition, current guideline recommended the dual antiplatelet (DAPT), clopidogrel plus aspirin, for a 3- to 6-month period after TAVI, however no evidences supports this approach. The antithrombotic regimen in patients undergoing TAVI is needed to be established.
To establish the antithrombotic regimen in patients undergoing TAVI,
985 studies on the registry are indexed under Aortic Valve Stenosis; 283 are open to participants now.
This study's enrollment of 23 is below the median of 200 across 424 observational studies indexed under Aortic Valve Stenosis.
Browse Aortic Valve Stenosis studies →Kumamoto University is the lead sponsor of 23 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with severe symptomatic aortic valve stenosis, undergoing transcatheter aortic valve implantation
Exclusion Criteria:
Changes in T-TAS parameters (AR-chip, PL-chip) during TAVI
To measure the thrombus formation area under the curve for AR-chip (AR10-AUC30), and PL-chip (PL24-AUC10) before and after TAVI.
Time frame: pre-, day 2, day 7, 1 month after device implantation
Changes in shear stress analyzed by using CFD analysis of contrast-enhanced CT
To measure the shear stress of aortic valve and aorta before and after TAVI by using CFD analysis of contrast-enhanced computed tomography (CT).
Time frame: pre-, day 7 after device implantation
Changes in von Willebrand factor multimer decrease
To measure the von Willebrand factor multimer decrease by using electrophoresis
Time frame: pre-, day 2 after device implantation
Periprocedural complication, particularly, bleeding complication defined by VARC-2 criteria.
Time frame: within 30 days after device implantation
Changes in plasma microRNAs
To measure the expression of plasma microRNAs before and after TAVI by using qPCR.
Time frame: pre-, day 2 after device implantation
This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.
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Kumamoto University