Assessments of Thrombus Formation in TAVI

Study Overview
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Brief Summary
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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, the investigators assess the changes in platelet thrombus formation and white thrombus formation in patients undergoing TAVI measured by Total Thrombus Formation Analysis System (T-TAS). the investigators analyze plasma microRNAs, and shear stress by using computational fluid dynamics (CFD) to clarify the mechanistic factors regarding those changes.

Official Title
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AssessmenTs of ThRombogenicity for trAnsCatheter aorTIc valVE Implantation by Total Thrombus-formation Analysis System (ATTRACTIVE-TTAS)

Conditions
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Aortic Valve Stenosis, Heart Valve Diseases

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: twenty years and older with the informed consent of the patient or support person in case of disability at baseline (patient intubated and ventilated) Exclusion Criteria: withdrawn the informed consent patients with trans-apical approach critical illness condition (severe infectious disease, cancer, severe bleeding disorder) transition to the surgical AVR

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | pre-, day 2, day 7, 1 month after device implantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | pre-, day 7 after device implantation | 
| Changes in von Willebrand factor multimer decrease | To measure the von Willebrand factor multimer decrease by using electrophoresis | pre-, day 2 after device implantation | 
| Periprocedural complication, particularly, bleeding complication defined by VARC-2 criteria. |  | within 30 days after device implantation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transcatheter aortic valve implantation