Trial document




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  DRKS00004937

Trial Description

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Title

Individualized Cryoballoon Energy pulmonary vein (PV) isolation guided by real time PV recordings
The "I C E" Trial

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Trial Acronym

"I C E -T" Trial

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The novel cryoballoon Advance is associated with increased cooling capacities and therefore potential side effects. Optimal cryoballoon energy titration is unknown. The cryoballoon Advance allows real time PVI observation in >85% of PVs and offers therefore systematic cryoballoon energy titration.

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Brief Summary in Scientific Language

AF ablation may be considered as primary treatment. The novel cryoballoon Advance is associated with increased cooling capacities and therefore potential side effects. Optimal cryoballoon energy titration is unknown. The cryoballoon Advance allows real time PVI observation in >85% of PVs and offers therefore systematic cryoballoon energy titration.

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Organizational Data

  •   DRKS00004937
  •   2013/09/11
  •   [---]*
  •   yes
  •   Approved
  •   FF70/2013, Ethikkommission der Landesärztekammer Hessen
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Secondary IDs

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

  •   I48.10 -  [generalization I48: Atrial fibrillation and flutter]
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Interventions/Observational Groups

  •   Standard Cryballoon Pulmonary vene isolation (PVI) + 1 bonus freeze with 28 mm baloon
  •   Cryballoon pulmonary vene isolation (PVI) but without bonus application, if first PVI during 60 secondes with 28 mm Balloon.
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject
  •   Active control (effective treament of control group)
  •   Treatment
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

Atrial tachycardia/ atrial fibrillation Reccurrence after 1 year Follow up

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Secondary Outcome

Procedural safety, procedural parameters

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2013/08/26
  •   100
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

symtomatic atrial fibrillation

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Exclusion Criteria

Contraindications for PVI, Pregnancy, Severe renal dysfunction stage III-V, Participation in another clincal trail, intracardiac thrombus

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Addresses

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    • Med. III, CCB am Markuskrankenhaus
    • Mr.  Dr. med.  KR Julian  Chun 
    • Wilhelm Epstein Str. 4
    • 60431  Frankfurt am Main
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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  • start of 1:1-Block address scientific-contact
    • Med. III, CCB am Markuskrankenhaus
    • Mr.  Dr. med.  KR Julian  Chun 
    • Wilhelm Epstein Str. 4
    • 60431  Frankfurt am Main
    • Germany
    end of 1:1-Block address scientific-contact
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    end of 1:1-Block address contact scientific-contact
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    • Med. IIICCB am Markus Krankenhaus
    • Mr.  Dr. med.  KR Julian  Chun 
    • Wilhelm Epstein Str. 4
    • 60431  Frankfurt/Main
    • Germany
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Sources of Monetary or Material Support

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    • Med. III, CCB am Markus Krankenhaus
    • Mr.  Dr. med.  KR Julian  Chun 
    • Wilhelm Epstein Str. 4
    • 60431  Frankfurt/Main
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2016/12/09
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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.