Trial document





This trial has been registered retrospectively.
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  DRKS00003465

Trial Description

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Title

Evaluation of cerebral microembolism related to left atrial ablation of paroxysmal atrial fibrillation

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Trial Acronym

SCM-study

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Atrial fibrillation is the most common arrhythmia. Currently, different interventional therapeutical strategies are available. Herewith, ablation can be performed in the antral region of the pulmonary veins (vessels which are draining the blood from the lungs into the left atrium) by the use of an ablation catheter and different energy sources. One possible complication of this procedure is the cerebral microembolism. This is an unintended deepening of particles into the brain, which happens during the procedure. Studies have shown that this occurs frequently (in 38.9% of the cases), but has no clinical impact and only can be demonstrated with special imaging techniques (Magnet Resonance Imaging). The above mentioned microembolisms are currently disregarded due to the lacking relevance for the patient. This study seeks to evaluate when such microembolisms occur during the procedure and whether this has any measurable impact to the cognitive function of the patient.

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Brief Summary in Scientific Language

The pulmonary vein isolation is an accepted treatment option of atrial fibrillation. Currently, different interventional methods as cryoablation, ablation using an irrigated tip catheter and ablation using the PVAC (pulmonary vein ablation catheter) are available. Different studies could demonstrate the occurrence of cerebral microembolisms using all of the ablation methods without any signs of clinical impact to the patient. Up to know, the cause, the time of occurrence, the quality of the particles and the clinical impact of the microembolisms are unknown. The SCM study seeks to evaluate the exact time of occurrence, the quality and the clinical impact of the microembolisms related to the particular ablation technique in a multicenter study setting. For this purpose we perform a pre- and postinterventional cerebral magnetic resonance imaging, a neuropsychological testing and a transcranial doppler, which allows for detection of time of occurrence, quality and quantity of cerebral microembolisms during the procedure.

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Organizational Data

  •   DRKS00003465
  •   2012/01/05
  •   [---]*
  •   yes
  •   Approved
  •   11-101-0134, Ethikkommission an der Universität Regensburg
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Secondary IDs

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Health Condition or Problem studied

  •   I48.10 -  [generalization I48: Atrial fibrillation and flutter]
  •   I63.4 -  Cerebral infarction due to embolism of cerebral arteries
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Interventions/Observational Groups

  •   Evaluation of cerebral microembolism during ablation of atrial fibrillation using the PVAC (catheter for mapping and ablation)
  •   Evaluation of cerebral microembolism during ablation of atrial fibrillation using the Cryoballoon for mapping and ablation
  •   Evaluation of cerebral microembolism during ablation of atrial fibrillation using irrigated tip ablation
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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Composite endpoint of cerebral microembolisms demonstrated by cerebral magnetic resonance imaging (the day before and two days and one month after the procedure), microembolisms recorded by transcranial doppler (during the procedure) and neuropsychological events measured by trail making test A, trail making test B, controlled oral word association test, block tapping test und Ruff 2&7 test (the day before and two days and one month after the procedure).

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Secondary Outcome

Influence of periprocedural management and technical settings on the occurence of cerebral microembolisms

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2011/08/01
  •   150
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

1. Patients with paroxysmal atrial fibrillation scheduled for pulmonary vein isolation (PVI alone, no additional ablation)
2. Provided written informed consent

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Exclusion Criteria

1. Age <18 and >80 years
2. Prior Stroke
3. Dementia
4. Prior pulmonary vein isolation
5. Severe claustrophobia
6. Implanted pacemaker/ICD (no MRI possible)
7. Persistent atrial fibrillation

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Addresses

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    • Universitätsklinikum Regensburg
    • Franz-Josef-Strauss-Allee 11
    • 93053  Regensburg
    • Germany
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    • Klinik und Poliklinik für Innere Medizin II Universitätsklinikum Regensburg
    • Mr.  Dr. med.  Christian  von Bary 
    • Franz-Josef-Strauss-Allee 11
    • 93053  Regensburg
    • Germany
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    • Klinik und Poliklinik für Innere Medizin II Universitätsklinikum Regensburg
    • Mr.  Dr. med.  Christian   von Bary 
    • Franz-Josef-Strauss-Allee 11
    • 93053  Regensburg
    • Germany
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Sources of Monetary or Material Support

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    • Medtronic GmbH
    • Earl-Bakken-Platz 1
    • 40670   Meerbusch
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2012/12/31
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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.