Microparticles in Severe Aortic Stenosis

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Home-Based Exercise Program For Recovery After Transcatheter Aortic Valve Replacement Microembolic Signals and Serum Markers of Neuronal Damage During Transcatheter Aortic Valve Implantation. CHANGE Neo™ TA Registry With ACURATE Neo™ Aortic Bioprosthesis and ACURATE Neo™ TA Transapical Delivery System FORWARD PRO Study Interventional Post-market Study With the Evolut™ PRO System SMT Embolic Deflection CE Mark Trial DEFLECT I Echocardiographic Assessment of Cardiovascular Changes in Long Term Space Flight Nitinol Circular Blade Functional Assessment In TAVI: FAITAVI CoreValve VIVA Study Evaluation of the Clinical Outcomes of CoreValve in Degenerative Surgical Aortic Bioprosthesis. POLESTAR Trial – An International Multi-center Early Discharge TAVI Program REPRISE EDGE 29 mm EU Study The CONFIDENCE Registry Interest of Cardiac Computed Tomography to Optimize and Improve the Procedure of TAVI Transapical Implantation of the Medtronic Engager Transcatheter Aortic Valve Implantation System – The Engager European Pivotal Trial Post-Market Follow-up of the CENTERA Transcatheter Heart Valve System SecOnd-generation seLf-expandable Versus Balloon-expandable Valves and gEneral Versus Local Anesthesia in TAVI Balloon Aortic Valvuloplasty During Surgical Aortic Valve Replacement The PROTEMBO SF Trial Adjuvant Radiation in Aortic Valvuloplasty – ARAVA Value of Oral Phytate (InsP6) in the Prevention of Progression of the Cardiovascular Calcifications Supra-Annular vs. Annular ValvEs for Small Annuli Heart Leaflet Technologies Valve Study A Study to Evaluate the Neuro-embolic Consequences of TAVR Femoral vs Radial Approach and MRI Evaluation of Strokes Mortality Post-TAVI and Correlation With Haemodynamic Parameters. 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Brief Title

Microparticles in Severe Aortic Stenosis

Official Title

Microparticles as an Inflammatory Marker in Severe Aortic Stenosis.

Brief Summary

      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

      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.

Study Type

Interventional

Primary Outcome

Difference in microparticle levels

Secondary Outcome

 Endothelial microparticle levels

Condition

Aortic Valve Stenosis

Intervention

Microparticle levels

Study Arms / Comparison Groups

 Single group
Description:  Patients with severe aortic stenosis treated with transcatheter aortic valve replacement (TAVR). Microparticle levels will be measured before and after TAVR.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Other

Estimated Enrollment

15

Start Date

June 2014

Completion Date

June 2015

Primary Completion Date

June 2015

Eligibility Criteria

        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.

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Pedro Lemos, MD PhD, ,

Location Countries

Brazil

Location Countries

Brazil

Administrative Informations

NCT ID

NCT02193035

Organization ID

31446114.1.0000.0068

Responsible Party

Principal Investigator

Study Sponsor

InCor Heart Institute

Study Sponsor

Pedro Lemos, MD PhD, Study Chair, Heart Institute - InCor. University of Sao Paulo Medical School

Verification Date

April 2016