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OpenTrials
Completed

NCT Number: NCT03248232

Assessments of Thrombus Formation in TAVI

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.

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Key information

Conditions

Aortic Valve Stenosis Aortic Valve Disease Cardiovascular Diseases Heart Diseases Heart Valve Diseases Ventricular Outflow Obstruction

Age range

20 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kumamoto University Hospital

Kumamoto, 860-8556, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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  • withdrawn the informed consent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

Treatment and study plan

Primary outcomes

  1. Changes in T-TAS parameters (AR-chip, PL-chip) during TAVI

    Time frame: 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 outcomes

  1. Changes in shear stress analyzed by using CFD analysis of contrast-enhanced CT

    Time frame: 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).

  2. Changes in von Willebrand factor multimer decrease

    Time frame: pre-, day 2 after device implantation

    To measure the von Willebrand factor multimer decrease by using electrophoresis

  3. Periprocedural complication, particularly, bleeding complication defined by VARC-2 criteria.

    Time frame: within 30 days after device implantation

Other outcomes

  1. Changes in plasma microRNAs

    Time frame: pre-, day 2 after device implantation

    To measure the expression of plasma microRNAs before and after TAVI by using qPCR.

Sponsors and collaborators

Lead sponsor

Kumamoto University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 14, 2017
Registry last updated
Oct 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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