Assessments of Thrombus Formation in TAVI

Completed

• Conditions: Aortic Valve Stenosis; Heart Valve Diseases

• Registration Number: NCT03248232
• Lead Sponsor: Kumamoto University

Brief Summary

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,

1. 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).

2. the investigators analyze plasma microRNAs, and shear stress by using computational fluid dynamics (CFD) to clarify the mechanistic factors regarding those changes.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-08-01
• Study First Submitted: 2017-08-09
• Study First Submitted QC: 2017-08-09
• Study First Posted: 2017-08-14
• Primary Completion: 2018-04-30
• Study Completion: 2018-06-30
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-30
• Last Update Posted: 2018-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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• withdrawn the informed consent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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in T-TAS parameters (AR-chip, PL-chip) during TAVI	pre-, day 2, day 7, 1 month after device implantation	To measure the thrombus formation area under the curve for AR-chip (AR10-AUC30), and PL-chip (PL24-AUC10) before and after TAVI.

Secondary Outcome Measures

Name	Time	Method
Periprocedural complication, particularly, bleeding complication defined by VARC-2 criteria.	within 30 days after device implantation
Changes in shear stress analyzed by using CFD analysis of contrast-enhanced CT	pre-, day 7 after device implantation	To measure the shear stress of aortic valve and aorta before and after TAVI by using CFD analysis of contrast-enhanced computed tomography (CT).
Changes in von Willebrand factor multimer decrease	pre-, day 2 after device implantation	To measure the von Willebrand factor multimer decrease by using electrophoresis

Trial Locations

Locations (1)

Kumamoto University Hospital; 🇯🇵 Kumamoto, Japan