Brief Title
Assessments of Thrombus Formation in TAVI
Official Title
AssessmenTs of ThRombogenicity for trAnsCatheter aorTIc valVE Implantation by Total Thrombus-formation Analysis System (ATTRACTIVE-TTAS)
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.
Study Type
Observational
Primary Outcome
Changes in T-TAS parameters (AR-chip, PL-chip) during TAVI
Secondary Outcome
Changes in shear stress analyzed by using CFD analysis of contrast-enhanced CT
Condition
Aortic Valve Stenosis
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
23
Start Date
August 1, 2017
Completion Date
June 30, 2018
Primary Completion Date
April 30, 2018
Eligibility Criteria
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patient or support person in case of disability at baseline (patient intubated and ventilated) Exclusion Criteria: - withdrawn the informed consent - patients with trans-apical approach - critical illness condition (severe infectious disease, cancer, severe bleeding disorder) -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
Gender
All
Ages
20 Years - 100 Years
Accepts Healthy Volunteers
No
Contacts
, ,
Location Countries
Japan
Location Countries
Japan
Administrative Informations
NCT ID
NCT03248232
Organization ID
Ethics No. 1440
Responsible Party
Principal Investigator
Study Sponsor
Kumamoto University
Study Sponsor
, ,
Verification Date
September 2018