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Incidence and Severity of Silent and Apparent Cerebral Embolism After Conventional and Minimal-invasive Transfemoral Aortic Valve Replacement

Sponsor
University Hospital, Bonn (Other)
Overall Status
Completed
CT.gov ID
NCT00883285
Collaborator
(none)
60
Enrollment
1
Location
56
Duration (Months)
1.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to compare the incidence of silent and apparent cerebral embolism between conventional and minimal-invasive transfemoral aortic valve repair.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Patients undergoing aortic valve repair (AVR) are included prospectively into the study. AVR techniques include the conventional technique, the transfemoral and the transapical approach. Before the intervention CT of the chest is performed preoperatively to assess the degree of aortic and aortic valve calcification. Patients undergo MRI of the brain, including diffusion weighted imaging (DWI) and neurological assessment (NIHSS score) within 48 h before and after the procedure to assess occurrence of cerebral embolism.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    60 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Incidence and Severity of Silent and Apparent Cerebral Embolism After Conventional and Minimal-invasive Transfemoral Aortic Valve Replacement
    Study Start Date :
    Apr 1, 2009
    Actual Primary Completion Date :
    Dec 1, 2013
    Actual Study Completion Date :
    Dec 1, 2013

    Arms and Interventions

    Arm Intervention/Treatment
    1

    conventional aortic valve replacement
    2

    transfemoral aortic valve replacement
    3

    transapical aortic valve replacement

    Outcome Measures

    Primary Outcome Measures

    1. Silent cerebral embolism [48 hours]

    Secondary Outcome Measures

    1. Apparent cerebral embolism [48 hours]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • aortic valve replacement
    Exclusion Criteria:
    • contraindication to undergo MRI

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Bonn Bonn NRW Germany 53105

    Sponsors and Collaborators

    • University Hospital, Bonn

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Claas P. Naehle, Assistant Professor of Radiology, University Hospital, Bonn
    ClinicalTrials.gov Identifier:
    NCT00883285
    Other Study ID Numbers:
    • 255/08
    First Posted:
    Apr 17, 2009
    Last Update Posted:
    Feb 3, 2014
    Last Verified:
    Jan 1, 2014
    Additional relevant MeSH terms:
    Stroke
    Intracranial Embolism
    Embolism
    Aortic Valve Disease

    Study Results

    No Results Posted as of Feb 3, 2014