Inflammatory Response to Aortic Valve Replacement

Aortic Valve Stenosis Clinical Trial

Official title:

Reduced Inflammatory Response Using Transcatheter Aortic Valve Replacement as Compared to Conventional Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03074838
• Other study ID #: 2012/7919
• Status: Completed
• Phase: N/A
• First received: February 28, 2017
• Last updated: March 3, 2017
• Start date: December 1, 2012
• Est. completion date: December 31, 2013

Study information

• Verified date: March 2017
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 31, 2013
• Est. primary completion date: December 31, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• known inflammatory disease and anti-inflammatory treatment

Related Conditions & MeSH terms

• Aortic Valve Stenosis

Intervention

Procedure:
• Transarterial aortic valve implantation - TAVI
After insertion of a guidewire, either through the femoral artery or through the ascending aorta, the aortic ostium is dilated by a balloon and the valve is introduced through a catheter and expanded in the ostium.
• Surgical aortic valve replacement - SAVR
The patient is operated through a sternotomy and coupled to a heart lung machine. The aorta is opened and the native valve excised. Then a biological artificial heart valve is sutured in place.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Oslo University Hospital	University of Oslo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Generation of several inflammatory markers measured through repeated blood samples	The total generation of several inflammatory markers is compared between the groups	24 hours
Secondary	Blood loss	ml blood loss compared between the groups	24 hrs
Secondary	Blood transfusion	Number of blood Products tranfused after the procedure	24 hrs