Assessments of Thrombus Formation in TAVI

Aortic Valve Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03248232
• Other study ID #: Ethics No. 1440
• Status: Completed
• Start date: August 1, 2017
• Est. completion date: June 30, 2018

Study information

• Verified date: September 2018
• Source: Kumamoto University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: June 30, 2018
• Est. primary completion date: April 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 100 Years

Eligibility

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• withdrawn the informed consent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

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Heart Valve Diseases

Locations

Country	Name	City	State
Japan	Kumamoto University Hospital	Kumamoto

Sponsors (1)

Lead Sponsor	Collaborator
Kumamoto University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in plasma microRNAs	To measure the expression of plasma microRNAs before and after TAVI by using qPCR.	pre-, day 2 after device implantation
Primary	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	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
Secondary	Changes in von Willebrand factor multimer decrease	To measure the von Willebrand factor multimer decrease by using electrophoresis	pre-, day 2 after device implantation
Secondary	Periprocedural complication, particularly, bleeding complication defined by VARC-2 criteria.		within 30 days after device implantation