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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02812953

Acronym

BIO TAVI

Enrollment

600

Registered

2016-06-24

Start date

2016-05-31

Completion date

2022-12-31

Last updated

2019-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Transcatheter Aortic Valve Replacement

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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* patient undergoing TAVR intervention * agreement given

Exclusion criteria

* severe thrombopenia ( \<40.10\^9/L)

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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)

Countries

France

Contacts

Primary ContactJean Philippe COLLET, MD, PhD

jean-philippe.collet@aphp.fr+33142162962

Backup ContactDelphine Brugier, PhD

delphine.brugier-ext@aphp.fr+33142162918

Outcome results