Ignite Creation Date:
2024-05-06 @ 10:22 AM
Last Modification Date:
2024-10-26 @ 12:29 PM
Study NCT ID:
NCT03248232
Status:
COMPLETED
Last Update Posted:
2018-10-02
First Post:
2017-08-09
Brief Title:
Assessments of Thrombus Formation in TAVI
Sponsor:
Kumamoto University
Organization:
Kumamoto University
Study Overview
Official Title:
AssessmenTs of ThRombogenicity for trAnsCatheter aorTIc valVE Implantation by Total Thrombus-formation Analysis System ATTRACTIVE-TTAS
Status:
COMPLETED
Status Verified Date:
2018-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None