Trial document




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  DRKS00010300

Trial Description

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Title

BEST-CLOSURE
BErlinSTeglitz- Cerebral Lesions after left atrial appendage clOSURE

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Trial Acronym

BEST Closure

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The study is the risk stratification and the improvement of security relating to thromboembolic events in the context of atrial appendage occlusion in patients with atrial fibrillation.
Due to the frequency of use of atrial appendage closures worldwide in the treatment of atrial fibrillation, the test results may be for a variety of patients is important.

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Brief Summary in Scientific Language

Objective of this study is to evaluate the incidence of clinically silent cerebral lesions (SCL) in patients with atrial fibrillation (AF) after atrial appendage closure (VOV). To detect these Events, before and after VOV, a MRI of the head as well as the implementation of the MoCA test had taken place. In addition, a follow up is planned after 2 weeks and a clinical follow-up after three months.

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Organizational Data

  •   DRKS00010300
  •   2016/04/18
  •   [---]*
  •   yes
  •   Approved
  •   EA 4/084/15, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   silent cerebral lesions
  •   Impairment of cognitive performance after VOV
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Interventions/Observational Groups

  •   MRI of the head as well as the implementation of the MoCA test before and after the VOV- intervention had taken place, follow-up after 2 weeks, clinical follow-up after three months. The first MRI takes place immediately before VOV. The second within 48h after VOV.
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Prevention
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Detection of silent cerebral lesions on MRI of the head before and after atrial appendage closure (VOV). The first MRI is performed immediately prior to VOV. The second cerebral MRI within 48h after VOV. The primary endpoint is reached when new cerebral lesions are visible on MRI after VOV.

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Secondary Outcome

Impairment of cognitive performance with neurocognitive questionnaire (MOCA) test before and after left atrial appendage occlusion. The secondary endpoint is achieved when there is a deterioration of MOCA test. The first MOCA test is performed immediately prior to VOV. The Second within 48h after VOV.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2016/04/20
  •   25
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

There are both women (after exclusion of pregnancy), and men who are over 18 years old, included with atrial fibrillation and atrial appendage closure planned. There must be no contraindications for MRI.
Consent for study participation.

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Exclusion Criteria

Pregnancy.
Neurological event within 3 months prior to the atrial appendage closure.

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Addresses

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    • Charite Berlin
    • Ms.  Dr.  Barbara  Bellmann 
    • Hindenburgdamm 30
    • 12203  Berlin
    • Germany
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    • Charite Berlin Abteilung für Kardiologie Campus Benjamin Franklin
    • Ms.  Dr. med.  Barbara  Bellmann 
    • Hindenburgdamm 30
    • 12003  Berlin
    • Germany
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    • Charite Berlin Abteilung für Kardiologie Campus Benjamin Franklin
    • Ms.  Dr.  Barbara  Bellmann 
    • Hindeburgdamm 30
    • 12203  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Charite Berlin Abteilung für Kardiologie Campus Benjamin Franklin
    • Ms.  Dr. med.  Barbara  Bellmann 
    • Hindenburgdamm 30
    • 12003  Berlin
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2017/05/09
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.