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Study of Platelet Activation by Severe Aortic Stenosis and Its Correction by Transcatheter Aortic Valve Implantation

NCT02504632 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2017-03-14

No results posted yet for this study

Summary

Study of platelet activation by severe aortic stenosis and its correction by Transcatheter Aortic Valve Implantation (TAVI)

Conditions

  • Aortic Stenosis

Interventions

OTHER

test

Peripheral venous citrated blood will be collected just before and 10-15 min after the implantation of the valve. Samples will be obtained after starting the infusion of contrast media. In peripheral venous blood before 24 h and after the procedure and at hospital discharge, 4-6 days when the usual transient thrombocytopenia after TAVI has recovered. The results will be used to analyse the kinetics of haematological changes in peripheral blood following aortic valve replacement. Platelet activation will be monitored by flow cytometry to assess the expression of specific membrane markers and the phosphorylation of signalling proteins, as well as the formation of platelet/monocyte aggregates.

OTHER

control group

In this group, only one sample (2 tubes filled with 4.5 ml, i.e. 9ml) will be obtained in venous peripheral blood to establish reference values in age-matched, aspirin-treated, atherosclerotic population.

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • University Hospital, Toulouse

    lead OTHER

Principal Investigators

  • Pierre SIE, MD PhD · University Hospital, Toulouse

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2015-10-31
Completion
2015-10-31

Countries

  • France

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02504632 on ClinicalTrials.gov