Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00016504

Trial Description

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Title

Register on cryo-ablation in local hospitals

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Trial Acronym

[---]*

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URL of the Trial

http://keine

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Brief Summary in Lay Language

[---]*

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Brief Summary in Scientific Language

Prospective, consecutive register on pulmonary vein isolation for paroxysmal or persistent atrial fibrillation to determine effectivity and complication rates with the cryoballoon ablation technique performed at local hospitals with less than 100 cryoballoon ablations/ year in a "real-life" setting. A total of 1000 procedures will be included in the registry. In addition, information on the procedural technique should be documented to understand treatment reality in local centers.

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Organizational Data

  •   DRKS00016504
  •   2019/01/28
  •   [---]*
  •   yes
  •   Approved
  •   Bo/41/2018, Ethikkommission bei der Ärztekammer Niedersachsen
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Secondary IDs

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

  •   I48 -  Atrial fibrillation and flutter
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Interventions/Observational Groups

  •   Prospective, consecutive register to define effectivity and complication data in pulmonary vein isolation using the cryoballoon ablation technique
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Characteristics

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

The primary endpoint is a security endpoint consisting of a combination of potentially important complication during pulmonary vein isolation: Death, insult, pericardial effusion, osophageal - atrial fistula, phrenic nerve palsy, vessel access complication.
The total number of the before mentioned complications with be counted and related to the total number of procedures.

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Secondary Outcome

The secondary endpoint is an effectivity endpoint as number of documented isolation of all 4 pulmonary veins directly after the pulmonary vein isolation

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2018/12/14
  •   1000
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

Consecutive patients undergoing pulmonary vein isolation for symptomatic atrial fibriallation at the study sites.

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Exclusion Criteria

No exclusion criteria apart from missing patient informed consent to participate in the study.

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Bonifatius Hospital Lingen
    • Mr.  Prof. Dr. med.  Rainer  Hoffmann 
    • Wilhelmstr. 13
    • 49808  Lingen
    • Germany
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    • Bonifatius Hospital Lingen
    • Mr.  Prof. Dr. med.  Rainer  Hoffmann 
    • Wilhelmstr. 13
    • 49808  Lingen
    • Germany
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    end of 1:1-Block address contact scientific-contact
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    • Bonifatius Hospital Lingen
    • Mr.  Prof. Dr. med.  Rainer  Hoffmann 
    • Wilhelmstr. 13
    • 49808  Lingen
    • Germany
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Sources of Monetary or Material Support

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    • Bonifatius Hospital Lingen
    • Mr.  Prof. Dr.  Rainer  Hoffmann 
    • Wilhelmstr. 13
    • 49808  Lingen
    • 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.