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

• Conditions: Transcatheter Aortic Valve Replacement

• Registration Number: NCT02812953
• Lead Sponsor: Action, France

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 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

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).

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-05-30
• Study First Submitted QC: 2016-06-22
• Study First Posted: 2016-06-24
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-29
• Last Update Posted: 2019-01-30
• Primary Completion: 2021-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

• patient undergoing TAVR intervention
• agreement given

Exclusion Criteria

• severe thrombopenia ( <40.10^9/L)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Major Adverse Cardiac Events	12 months	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
Bleeding	12 months	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

Secondary Outcome Measures

Name	Time	Method
mean pressure transprosthetic gradient	within ten days after valve replacement	value of the mean pressure transprosthetic gradient after TAVR procedure will be assessed by TTE (transthoracic echography) or TOE (transesophageal echography)

Trial Locations

Locations (1)

Hopital Pitie Salpetriere; 🇫🇷 Paris, France