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Inflammatory Response to Aortic Valve Replacement

NCT03074838 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2017-03-09

No results posted yet for this study

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.

Conditions

  • Aortic Valve Stenosis

Interventions

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.

PROCEDURE

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.

Sponsors & Collaborators

  • University of Oslo

    collaborator OTHER

  • Oslo University Hospital

    lead OTHER

Principal Investigators

  • Erik Fosse, MD PhD · Oslo University Hospital/University of Oslo

  • Karoline KH Fiane, Med Student · University of Oslo

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-01
Primary Completion
2013-12-31
Completion
2013-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03074838 on ClinicalTrials.gov