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

NCT ID: NCT02812953

Last Updated: 2019-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-05-31

Study Completion Date

2022-12-31

Brief Summary

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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

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Detailed Description

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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).

Conditions

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Transcatheter Aortic Valve Replacement

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* patient undergoing TAVR intervention
* agreement given

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Action, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hopital Pitie Salpetriere

Paris, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Jean Philippe COLLET, MD, PhD

Role: CONTACT

[email protected]
+33142162962

Delphine Brugier, PhD

Role: CONTACT

[email protected]
+33142162918

Other Identifiers

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2015-A01832-47

Identifier Type: -

Identifier Source: org_study_id

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