Assessments of Thrombus Formation in TAVI

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

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.

Study Overview

• Status: Completed
• Conditions: Aortic Valve Stenosis; Heart Valve Diseases

• Study Type: Observational
• Enrollment (Actual): 23

Contacts and Locations

Study Locations

• Japan
  • Kumamoto, Japan, 860-8556
    • Kumamoto University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 96 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with severe symptomatic aortic valve stenosis, undergoing transcatheter aortic valve implantation

Description

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• withdrawn the informed consent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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

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

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: Kumamoto University

Publications and helpful links

General Publications

• Ishii M, Kaikita K, Mitsuse T, Nakanishi N, Oimatsu Y, Yamashita T, Nagamatsu S, Tabata N, Fujisue K, Sueta D, Takashio S, Arima Y, Sakamoto K, Yamamoto E, Tsujita K. Reduction in thrombogenic activity and thrombocytopenia after transcatheter aortic valve implantation - The ATTRACTIVE-TTAS study. Int J Cardiol Heart Vasc. 2019 Mar 28;23:100346. doi: 10.1016/j.ijcha.2019.100346. eCollection 2019 Jun.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Actual): April 30, 2018
• Study Completion (Actual): June 30, 2018

Study Registration Dates

• First Submitted: August 9, 2017
• First Submitted That Met QC Criteria: August 9, 2017
• First Posted (Actual): August 14, 2017

Study Record Updates

• Last Update Posted (Actual): October 2, 2018
• Last Update Submitted That Met QC Criteria: September 30, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Transcatheter aortic valve implantation
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Heart Valve Diseases
• Other Study ID Numbers: Ethics No. 1440

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No