Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00009786

Trial Description

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Title

Follow Up of patients by use of implantable loop recorders after catheter ablation of atrial flutter

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Trial Acronym

FLUTFIB

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Catheterablation is an Intervention, which enable the desolation of a heart Areal to determine a dysrhythmia. Atrial fibrillation occurs often after a catheter Ablation of atrial flutter, which promote a incurrence of a thrombus coagulated blood). So it is important to know how often and in which time period after a ablation atrial fibrillation occurs and if there are some risk factors. This affects the oral anticoagulation to prevent the coagulation of blood and consequently reduce the risk of a stroke.

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Brief Summary in Scientific Language

Atrial fibrillation occur often after catheter ablation of typical atrial flutter and can be detected by implantable loop recorder. But it depends on the risk factors. If the physicians know about these risk factors, they can adapt the oral anticoagulation.

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Organizational Data

  •   DRKS00009786
  •   2018/04/12
  •   [---]*
  •   yes
  •   Approved
  •   EA2/055/15, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

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

  •   I48.9 -  [generalization I48: Atrial fibrillation and flutter]
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Interventions/Observational Groups

  •   During a time period of two years after catheter Ablation of atrial flutter the patients are controlled. At the time of 3, 6, 12, 18, 24 month after intervention. Documented are pre-existing illness, medication and the appearance of dysrhythmia and relating symptoms.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   N/A
  •   No
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Primary Outcome

The follow-up visits be made after 3, 6, 12, 18 and 24 months. The follow ups should show how often and in which time period atrial fibrillation occur after the catheter Ablation of atrial flutter and if there are some risk factors.

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Secondary Outcome

- time between intervention and atrial fibrillation
- appearance of other arrhythmia
- use of oral anticoagulants
- correlation with symptoms
- identification of risk factors

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
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Recruitment

  •   Actual
  •   2015/10/22
  •   100
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

- age over 18
- give consent
- informed consent in wirting
- Ablation of typical atrial flutter

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Exclusion Criteria

- age under 18
- documented atrial fibrillation

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Addresses

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    • Charité-Universitätsmedizin Berlin
    • Mr.  Dr.  Martin  Huemer 
    • Hindenburgdamm 30
    • 12203  Berlin
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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    • Medizinische Klinik für Kardiologie der Charité – Universitätsmedizin Berlin
    • Mr.  Dr.  Martin  Huemer 
    • Hindenburgdamm 30
    • 12203   Berlin
    • Germany
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    • Medizinische Klinik für Kardiologie der Charité-Universitätsmedizin Berlin (Campus Benjamin Franklin und Campus Virchow Klinikum)
    • Mr.  Dr.  Martin  Huemer 
    • Hindenburgdamm 30
    • 12203  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • St. Jude Medical GmbH
    • 55117  Saint Paul, Minnesota
    • United States
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    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting ongoing
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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.