Assessments of Thrombus Formation in TAVI

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03248232

Enrollment

Registered

2017-08-14

Start date

2017-08-01

Completion date

2018-06-30

Last updated

2018-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Valve Stenosis, Heart Valve Diseases

Keywords

Transcatheter aortic valve implantation

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to 100 Years

Healthy volunteers

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* withdrawn the informed consent * patients with trans-apical approach * critical illness condition (severe infectious disease, cancer, severe bleeding disorder) *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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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
Periprocedural complication, particularly, bleeding complication defined by VARC-2 criteria.	within 30 days after device implantation	—

Other

Measure	Time frame	Description
Changes in plasma microRNAs	pre-, day 2 after device implantation	To measure the expression of plasma microRNAs before and after TAVI by using qPCR.

Countries

Japan

Outcome results