Inflammatory Response to Aortic Valve Replacement

Status Completed

Clinical Trial Summary

A controlled un-randomized trial where the inflammatory response in 18 patients admitted for TAVI procedure is compared to the inflammatory response in 18 patients admitted for conventional surgical valve replacement. Clinical outcomes are recorded and compared between the Groups. As a secondary endpoint, the inflammatory response was also compared between the patients receiving either transfemoral or trans aortal TAVI.

Clinical Trial Description

18 patients admitted successively for conventional surgical aortic valve replacement and 18 patients admitted for transcatheter aortic valve implantation (TAVI) (9 transfemoral and 9 transaortic) are included.

A plasma sample is obtained at defined timepoints before, during and after surgery. At each time points the following biomarkers are analyzed:Concentrations of the complement activation products C3bc and the terminal C5b-9 complement complex (TCC), the neutrophil release product myeloperoxidase (MPO), the cytokines IL-6, eotaxin, MCP-1 and MIP-1β (12). As marker of a myocardial cellular injury troponin T levels will be analyzed. The following clinical outcomes will also be monitored: Death (in hospital, 30 day and one year), blood transfusion, stroke, myocardial infarction.

A dedicated registry will be established at the hospital according to the hospital's standard for storage of patient data. The registry will be deleted after completion of the study. ;

Study Design

Related Conditions & MeSH terms

Aortic Valve Stenosis

Clinical Trial Details

NCT number	NCT03074838
Study type	Interventional
Source	Oslo University Hospital
Contact
Status	Completed
Phase	N/A
Start date	December 1, 2012
Completion date	December 31, 2013

View Details

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