Microparticles in Severe Aortic Stenosis

Study Overview
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Brief Summary
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Microparticles are small cell fragments that can induce fat plaques, calcification and formation of thrombus. They can be released through multiple stimulations, but also the high flow of blood through partially obstructed aortic valves. In patients with severely obstructed aortic valves the investigators hypothesize that microparticles levels will be elevated and that they will go down after percutaneous treatment of the valves.

Detailed Description
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Microparticle (MPs) levels and subtypes according to endothelial cell, macrophage and platelet markers will be measured by flow-cytometry using appropriate fluorochromes. Patient baseline (including measures of severity of aortic stenosis and its calcification), procedural data, and clinical evolution will be collected. Inflammatory markers will be measured, which along with clinical date will be tested for correlation with microparticle levels. Patients MPs will be measured before and after percutaneous treatment of the severe aortic stenosis.

Official Title
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Microparticles as an Inflammatory Marker in Severe Aortic Stenosis.

Conditions
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Aortic Valve Stenosis

Intervention / Treatment
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* Other: Microparticle levels


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical indication to be treated with transcatheter aortic valve replacement. Exclusion Criteria: Non native aortic valve Moderate aortic regurgitation The following complications following valve implantation: patient instability, need for vasoactive pressors, sepsis and severe infections, stroke.

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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single group<br>Patients with severe aortic stenosis treated with transcatheter aortic valve replacement (TAVR). Microparticle levels will be measured before and after TAVR. | Other: Microparticle levels<br>* Microparticle levels will be evaluated with flow cytometry and nanoparticle tracking analysis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in microparticle levels | Difference of total microparticle levels before and after treatment of patients with percutaneous aortic valve replacement | Day 5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endothelial microparticle levels | Difference of endothelial microparticle levels before and after treatment of patients with percutaneous aortic valve replacement | Day 5 | 
| Macrophage microparticle levels | Difference of macrophage microparticle levels before and after treatment of patients with percutaneous aortic valve replacement | Day 5 | 
| Platelet microparticle levels | Difference of platelet microparticle levels before and after treatment of patients with percutaneous aortic valve replacement | Day 5 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Microparticles, Severe aortic stenosis, Calcified aortic stenosis, transcatheter aortic valve replacement