Biological Collection and Registry of Patients Who Will Have a TAVR (Transcatheter Aortic Valve Replacement) Intervention

Transcatheter Aortic Valve Replacement Clinical Trial

— BIO TAVI  

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02812953
• Other study ID #: 2015-A01832-47
• Status: Recruiting
• Start date: May 2016
• Est. completion date: December 2022

Study information

• Verified date: January 2019
• Source: Action, France
• Contact: Jean Philippe COLLET, MD, PhD
• Phone: +33142162962
• Email: jean-philippe.collet[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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 traps(flow cytometry and ELISA) analyses will be performed at the time of blood sampling. Aliquots of plasma will be stored and frozen for further analyses

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patient undergoing TAVR intervention

• agreement given

Exclusion Criteria:

• severe thrombopenia ( <40.10^9/L)

Related Conditions & MeSH terms

• Transcatheter Aortic Valve Replacement

Locations

Country	Name	City	State
France	Hopital Pitie Salpetriere	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Action, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major Adverse Cardiac Events	stroke/transient ischemic attack; acute coronary syndrome; hospitalization for cardiac insufficiency, cardiovascular or unexplained deaths will be collected at 12 month by phone contact with the patient or his/her relatives or his/her treating physician	12 months
Primary	Bleeding	Serious bleeding event (BLEED II or more) will be collected at 12 month by phone contact with the patient or his/her relatives or his/her treating physician	12 months
Secondary	mean pressure transprosthetic gradient	value of the mean pressure transprosthetic gradient after TAVR procedure will be assessed by TTE (transthoracic echography) or TOE (transesophageal echography)	within ten days after valve replacement