Trial document




drksid header

  DRKS00013013

Trial Description

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Title

ATrial Fibrillation Registry and BIobank UlM

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Trial Acronym

ATRIUM

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Propspective observational study to collect baseline characteristics, procedural and outcome data as well as biomaterial samples to evaluate benefit of catheter ablation in patients with atrial fibrillation

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Brief Summary in Scientific Language

Aim of this study is to analyse long-term outcome data of patients with paroxysmal or persistant atrial fibrillation undergoing catheter ablation. Baseline characteristics (including genetic background), procedural data as well as biomarkers will be evaluated as potential predictors of atrial fibrillation or recurrence of atrial fibrillation.

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Organizational Data

  •   DRKS00013013
  •   2017/12/05
  •   [---]*
  •   yes
  •   Approved
  •   05/17, Ethik-Kommission der Universität Ulm
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Secondary IDs

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

  •   I48.0 -  Paroxysmal atrial fibrillation
  •   I48.1 -  Persistent atrial fibrillation
  •   I48.3 -  Typical atrial flutter
  •   I48.4 -  Atypical atrial flutter
  •   I48.9 -  Atrial fibrillation and atrial flutter, unspecified
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Interventions/Observational Groups

  •   Propspective observational study to collect baseline characteristics, procedural and outcome data as well as biomaterial samples to evaluate benefit of catheter ablation in patients with atrial fibrillation
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Characteristics

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

Recurrence of atrial fibrillation, Hospitalisation, Symptomatic Improvement (EHRA-Score)

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Secondary Outcome

Incidence of procedural complications such as pericardial tamponade, phrenic nerve palsy esophageal lesions or stroke.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2017/12/05
  •   2000
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   99   Years
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Additional Inclusion Criteria

- documented paroxysmal or persistant atrial fibnrillation
- written informed consent
- age > 18 years

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Exclusion Criteria

- permanent atrial fibrillation
- LA > 60 mm
- unable to consent

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Addresses

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    • Leiter Arbeitsgruppe Elektrophysiologie - Universitätsklinikum Ulm - Innere Medizin II
    • Mr.  Dr. med.  Tillman  Dahme 
    • Albert-Einstein-Allee 23
    • 89081  Ulm
    • Germany
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    • stellv. Leiter Arbeitsgruppe Elektrophysiologie - Universitätsklinikum Ulm - Innere Medizin II
    • Mr.  Dr. med.  Alexander  Pott 
    • Albert-Einstein-Allee 23
    • 89081  Ulm
    • Germany
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    • Study Coordinator Arbeitsgruppe Elektrophysiologie - Universitätsklinikum Ulm - Innere Medizin II
    • Ms.  Beate  Polte (MBA) 
    • Albert-Einstein-Allee 23
    • 89081  Ulm
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Ulm, Kliniken am oberen Eselsberg
    • Albert-Einstein-Allee 23
    • 89081  Ulm
    • Germany
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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.