Trial document




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  DRKS00010840

Trial Description

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Title

A prospective, randomized, controlled, non-inferiority trial comparing RF- energy and cryoenergy in pulmonary vein isolation in patients with persistent atrial fibrillation

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Trial Acronym

FreezeAF II

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Comparison of two different methods used for pulmonary vein isolation in patients with atrial fibrillation

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Brief Summary in Scientific Language

Comparison of pulmonary vein isolation in patients with persistent atrial fibrillation with cryoballoon versus radiofrequency ablation

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Organizational Data

  •   DRKS00010840
  •   2017/04/26
  •   [---]*
  •   yes
  •   Approved
  •   377/16, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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

  •   I48.1 -  [generalization I48: Atrial fibrillation and flutter]
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Interventions/Observational Groups

  •   Ablation using cryoballon
  •   Ablation using radiofrequency energy
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   IV
  •   N/A
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Primary Outcome

Combined endpoint defined as no episodes of atrial arrhythmias lasting longer that 24 h

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Secondary Outcome

Time to recurrence of atrial arrhythmia
Occurrence of left atrial flutter
Early recurrence during blanking perios
Atrial arrhythmia of more than 30 seconds
Long-term clinical success
Total radiation exposure
Total procedure duration
Bleedings

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Planned
  •   2017/11/01
  •   340
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

1. Documented PersAF: at least 1 episode of PersAF > 7 days and less than 2 years (at least one episode documented)
2. Age 18-80 years
3. Documented inefficacy of at least 1 AAD including beta- blockers
4. Willigness to have rhythm monitoring performed by either internal loop recorder readings or 7 to 14 day external Event recorder reading

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Exclusion Criteria

1.LA size > 55 mm
2. LA thrombus
3. Previous LA ablation/surgery
4. Unstable angina
5. Myocardial infarction within three months
6. Cardiac surgery or PTCA within three months
7. Mitral prosthesis
8. EF <40%
9. Heart failure NYHA III-IV
10. Hypertrophic cardiomyopathy
11. Severe or moderate mitral regurgitation
12. Any condition contraindicating chronic anticoagulation
13. Stroke or TIA within six months
14. Thrombocytosis, thrombocytopenia
15. Pregnancy
16. Uncontrolled hyperthyroidism
17. Life expectancy <1year

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Medizinische Klinik IVStädtisches Klinikum Karlsruhe
    • Mr.  Prof. Dr. med.  Claus  Schmitt 
    • Moltkestr. 90
    • 76133  Karlsruhe
    • Germany
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    • Medizinische Klinik IVStädtisches Klinikum Karlsruhe
    • Mr.  Prof. Dr. med.  Claus  Schmitt 
    • Moltkestr. 90
    • 76133  Karlsruhe
    • Germany
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    • Medizinische Klinik IVStädtisches Klinikum Karlsruhe
    • Mr.  Prof. Dr. med.  Claus  Schmitt 
    • Moltkestr. 90
    • 76133  Karlsruhe
    • Germany
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Sources of Monetary or Material Support

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    • Städtisches Klinikum Karlsruhe
    • Mr.  Dr. med.  Patrick  Hörmann 
    • Moltkestr. 90
    • 76133  Karlsruhe
    • Germany
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Status

  •   Recruiting planned
  •   [---]*
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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.