Ignite Creation Date:
2024-05-06 @ 8:45 AM
Last Modification Date:
2024-10-26 @ 12:04 PM
Study NCT ID:
NCT02812953
Status:
UNKNOWN
Last Update Posted:
2019-01-30
First Post:
2016-05-30
Brief Title:
Biological Collection and Registry of Patients Who Will Have a TAVR Transcatheter Aortic Valve Replacement Intervention
Sponsor:
Action France
Organization:
Action France
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2019-01
Last Known Status:
RECRUITING
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:
BIO TAVI
Brief Summary:
A sample of plasma and whole blood will be obtained at 4 time points pre-procedural early post-procedural at hospital discharge and during an eventual visite at 3 or 6 months post-procedural Test for platelet reactivity LTA light transmittance aggregometry and Elisa PRI Platelet reactivity index multimeric VWF von Willebrand factor and blood level of NET neutrophil extracellular trapsflow cytometry and ELISA analyses will be performed at the time of blood sampling Aliquots of plasma will be stored and frozen for further analyses
Detailed Description:
There are two major objectives
To correlate changes in VWF platelet reactivity and blood level of NET after TAVR with clinical outcomes
To correlate changes in VWF platelet reactivity and blood level of NET with antithrombotic regimens after TAVR direct anticoagulants apixaban versus standard of care ie Vitamin K antagonist or antiplatelet therapy
To correlate changes in VWF platelet reactivity and blood level of NET after TAVR with clinical outcomes
To correlate changes in VWF platelet reactivity and blood level of NET with antithrombotic regimens after TAVR direct anticoagulants apixaban versus standard of care ie Vitamin K antagonist or antiplatelet therapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None