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Inflammatory Response to Aortic Valve Replacement

Primary Purpose

Aortic Valve Stenosis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Transarterial aortic valve implantation - TAVI
Surgical aortic valve replacement - SAVR
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aortic Valve Stenosis focused on measuring Cardiac surgery, TAVI

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • known inflammatory disease and anti-inflammatory treatment

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Transarterial aortic valve implantation

    Surgical aortic valve replacement

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Generation of several inflammatory markers measured through repeated blood samples
    The total generation of several inflammatory markers is compared between the groups

    Secondary Outcome Measures

    Blood loss
    ml blood loss compared between the groups
    Blood transfusion
    Number of blood Products tranfused after the procedure

    Full Information

    First Posted
    February 28, 2017
    Last Updated
    March 3, 2017
    Sponsor
    Oslo University Hospital
    Collaborators
    University of Oslo
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03074838
    Brief Title
    Inflammatory Response to Aortic Valve Replacement
    Official Title
    Reduced Inflammatory Response Using Transcatheter Aortic Valve Replacement as Compared to Conventional Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    December 1, 2012 (Actual)
    Primary Completion Date
    December 31, 2013 (Actual)
    Study Completion Date
    December 31, 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Oslo University Hospital
    Collaborators
    University of Oslo

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.
    Detailed 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Aortic Valve Stenosis
    Keywords
    Cardiac surgery, TAVI

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    A case Control study were patients undergoing two surgical Methods for aortic valve repair is compared
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    36 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Transarterial aortic valve implantation
    Arm Type
    Experimental
    Arm Description
    Patients that are treated by trans arterial valve implantation (TAVI)
    Arm Title
    Surgical aortic valve replacement
    Arm Type
    Active Comparator
    Arm Description
    Patients that are treated by surgical aortic valve replacement (SAVR)
    Intervention Type
    Procedure
    Intervention Name(s)
    Transarterial aortic valve implantation - TAVI
    Intervention Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    Surgical aortic valve replacement - SAVR
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Generation of several inflammatory markers measured through repeated blood samples
    Description
    The total generation of several inflammatory markers is compared between the groups
    Time Frame
    24 hours
    Secondary Outcome Measure Information:
    Title
    Blood loss
    Description
    ml blood loss compared between the groups
    Time Frame
    24 hrs
    Title
    Blood transfusion
    Description
    Number of blood Products tranfused after the procedure
    Time Frame
    24 hrs

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients eligible for aortic valve replacement without need for concurrent surgery Exclusion Criteria: known inflammatory disease and anti-inflammatory treatment
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Erik Fosse, MD PhD
    Organizational Affiliation
    Oslo University Hospital/University of Oslo
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Karoline KH Fiane, Med Student
    Organizational Affiliation
    University of Oslo
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    29233022
    Citation
    Fiane KKH, Dahle G, Bendz B, Halvorsen PS, Abdelnoor M, Mollnes TE, Fosse E. Reduced inflammatory response by transcatheter, as compared to surgical aortic valve replacement. Scand Cardiovasc J. 2018 Feb;52(1):43-50. doi: 10.1080/14017431.2017.1416157. Epub 2017 Dec 12.
    Results Reference
    derived

    Learn more about this trial

    Inflammatory Response to Aortic Valve Replacement

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