Effects of Left Ventricular Assist Device Implantation on the Phenotype of Blood Platelets and Leucocytes

Study Overview
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Brief Summary
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To compare in vivo platelet and leukocyte activation and phenotype before and after Left ventricular assist device (LAVD) implantation

Detailed Description
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The present study plan to investigate platelet activation in vivo using a variety of biomarkers previously identified as sensitive to high shear stress in patients with severe aortic valve stenosis before and after trans arterial valve replacement. As one of the best biomarker is a high degree of platelet-leukocyte interactions, the study will study in parallel leukocytes activation/differentiation. These parameters will be compared at 3 time-points, before and after LAVD implantation in ambulatory patients.

Official Title
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Study on the Effects of Left Ventricular Assist Device Implantation on the Phenotype of Blood Platelets and Leucocytes

Conditions
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Cardiac Insufficiency

Intervention / Treatment
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* Other: Blood sampling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: elective implantation of LAVD (Heartmate II), written informed consent to the study Patients with health insurance Exclusion Criteria: treatment or procedure that could affect platelet functions or turn-over(low-dose aspirin is allowed). Pregnancy or breastfeeding Juridical Protection

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LAVD implantation<br>Ten patients before and after LAVD implantation had blood sampling | Other: Blood sampling<br>* Three venous blood sampling before the left ventricular assist device implantation and 1 and 2 months after implantation in ambulatory patients.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Platelet activation | To compare platelet activation in vivo, using a composite criteria determinated by variety of biomarkers of activation analysed by flow cytometry and enzyme-linked immunosorbent assay (ELISA) | Month 2 after LAVD implantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of circulating platelet-leukocyte conjugate | To determine the level of circulating platelet-leukocyte conjugate by flow cytometry | Month 2 after LAVD implantation | 
| Changes in leukocyte phenotype | To determine the leukocyte phenotype which is a composite criteria analysed by flow cytometry, ELISA and lipidaemic analysis | Month 2 after LAVD implantation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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left ventricular assist device, platelet-leukocyte conjugates, lipo-oxygenase products