Inflammatory Response to Aortic Valve Replacement

University of Oslo (UIO)

Status: Completed

Conditions: Aortic Valve Stenosis

Treatments: Procedure: Transarterial aortic valve implantation - TAVI; Procedure: Surgical aortic valve replacement - SAVR

Study type: Interventional

Funder types: Other

Identifiers

NCT03074838

2012/7919

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients eligible for aortic valve replacement without need for concurrent surgery

Exclusion criteria

• known inflammatory disease and anti-inflammatory treatment

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

Transarterial aortic valve implantation

Experimental group

Description:

Patients that are treated by trans arterial valve implantation (TAVI)

Treatment:

Procedure: Transarterial aortic valve implantation - TAVI

Surgical aortic valve replacement

Active Comparator group

Description:

Patients that are treated by surgical aortic valve replacement (SAVR)

Treatment:

Procedure: Surgical aortic valve replacement - SAVR