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

A

Action, France

Status

Unknown

Conditions

Transcatheter Aortic Valve Replacement

Study type

Observational

Funder types

Other

Identifiers

NCT02812953
2015-A01832-47

Details and patient eligibility

About

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

Full 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).

Enrollment

600 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • patient undergoing TAVR intervention
  • agreement given

Exclusion criteria

  • severe thrombopenia ( <40.10^9/L)

Trial contacts and locations

1

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Central trial contact

Delphine Brugier, PhD; Jean Philippe COLLET, MD, PhD

Data sourced from clinicaltrials.gov

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