Trial document





This trial has been registered retrospectively.
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  DRKS00011360

Trial Description

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Title

Treatment of supraventricular tachycardia with Cryo-Ablation under ICE (intracardiac echocardiography) navigation

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Trial Acronym

ICE-SVT

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URL of the Trial

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Brief Summary in Lay Language

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Brief Summary in Scientific Language

Supraventricular tachykardias do not limit the life expectancy of the affected patients. The Catheter-Ablation mostly eliminates the symptoms of These patients. The Exposition to fluoroscopy may lead to so-called stochastic Radiation damage. The aim of the study is to inestigate the combination of a safe Ablation type with a zero- or near-zero fluoroscopy Navigation technique.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00011360
  •   2016/12/14
  •   [---]*
  •   yes
  •   Approved
  •   86/16, Ethikkommission der Medizinischen Fakultät der Otto-von-Guericke-Universität Magdeburg
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Secondary IDs

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Health Condition or Problem studied

  •   I47.1 -  Supraventricular tachycardia
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Interventions/Observational Groups

  •   Catheterablation under fluoroscopic control is the first choise treatment of supraventricular tachycardias. We'd like to investigate the combination of intravscular echocardiography (ICE) Navigation and Cryo-Ablation in Patients with presumed supraventricular Tachykardias.
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   No
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Primary Outcome

The aim of the study is to observe and analyse the fluoroscopic time and radiation dose (both parameters are routinely documented for every electrophysiologic study) during Cryothermal-ablation of atrio-ventricular-node-reentry-tachycardia under intracardiac-echocardiography-Navigation.

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Secondary Outcome

Secondary endpoint of the study is to assess and analyse the success rate of the cryothermal-ablation for treatment of atrioventricular-node-reentry-tachycardia under intracardiac-echocardiography-Navigation. Success is defined as clinical freedom from arrhythmia after 3 and 12 months.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2016/10/28
  •   50
  •   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

documented or clinical probably supraventricular tachycardia

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Exclusion Criteria

documented or clinical probably ventricular tachycardia, atrial fibrillation, atrial flutter,
fever, acute infection, acute or subacute leg vein thrombosis or pulmonary embolism, pregnancy

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Addresses

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    • Universitätsklinikum Magdeburg
    • Leipziger Str. 44
    • 39120  Magdeburg
    • Germany
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    • Universitätsklinikum MagdeburgKlinik für Kardiologie und Angiologie
    • Mr.  Dr. med.  Blerim  Luani 
    • Leipzigerstr. 44
    • 39120  Magdeburg
    • Germany
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    • Universitätsklinikum MagdeburgKlinik für Kardiologie und Angiologie
    • Mr.  Dr. med.  Blerim  Luani 
    • Leipzigerstr. 44
    • 39120  Magdeburg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Magdeburg
    • Leipziger Str. 44
    • 39120  Magdeburg
    • 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.