Trial document




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  DRKS00013510

Trial Description

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Title

Aortic lesions after Radiofrequency and Cryoballoon Therapy In patients undergoing Catheter ablation of Atrial Fibrillation

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Trial Acronym

ARCTIC AF

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URL of the Trial

http://nicht vorhanden

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Brief Summary in Lay Language

The objective of this study is to evaluate the incidence of clinically silent aortic lesions in patients with radiofrequency (RF) / cryo-ablation in atrial fibrillation using cardiac or aortic magnetic resonance imaging (MRI). Magnetic resonance imaging of the aorta before ablation and after ablation is planned to capture the above changes. The clinical relevance of aortic lesions is still unclear.

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Brief Summary in Scientific Language

The aim of our study is to investigate the incidence of clinically silent aortic lesions by magnetic resonance imaging in the context of radiofrequency ablation of atrial fibrillation compared to cryo-energy (cryoballoon). Atrial fibrillation is a very common disease. In Europe, more than 6 million people suffer from this heart rhythm disorder. The electrical isolation of the pulmonary veins is an established and widely used therapy option for the treatment of atrial fibrillation. Via the veins of the groin, the heart is reached with the catheters. To reach the pulmonary veins, catheters must be placed in the left atrium. For this, it is necessary to perform a transseptal puncture to introduce the catheters into the left atrium. The aim is to isolate the pulmonary veins from the atrium, so that no interference potential from the pulmonary veins can bring the heart rhythm out of rhythm.
In addition to the occurrence of strokes, the literature has described lesions of the neighboring organs as a result of the delivery of energy through the catheters. In up to 48% of cases, for example, changes to the esophagus are described. For this reason, it is now an established method to perform a continuous measurement of the temperature in the esophagus during ablation in order to prevent precisely these lesions. This is routinely applied to atrial fibrillation ablation in our department as part of the institute standard. Recent studies suggest that the local effects of energy delivery also cause aortic lesions. The aorta often shows an immediate anatomical proximity to the posterior wall of the left atrium. In the only study to date, a prevalence of 60% has been reported for the occurrence of aortic lesions following pulmonary vein isolation. However, these were only retrospectively analyzed patient data after RF ablation. The aim of our study is to evaluate these aortic lesions by means of magnetic resonance tomography in the context of cryoenergy in comparison to RF energy. With regard to the success rate and the complication rate, according to the current data, cryo and radiofrequency ablation are comparable in terms of effectiveness and safety in the treatment of atrial fibrillation.

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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

  •   DRKS00013510
  •   2017/12/04
  •   [---]*
  •   yes
  •   Approved
  •   17-370, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
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Secondary IDs

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Health Condition or Problem studied

  •   I48.0 -  Paroxysmal atrial fibrillation
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Interventions/Observational Groups

  •   Patients with paroxysmal atrial fibrillation randomized to the cryo-ablation group receive aortic MRI 24h prior to ablation and cryo-ablation at the following day. The day after the procedure, the second aortic MRI will performed.
  •   Patients with paroxysmal atrial fibrillation randomized to the radiofrequency-ablation group receive aortic MRI 24h prior to ablation and radiofreqeunecy-ablation at the following day. The day after the procedure, the second aortic MRI will performed.
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Characteristics

  •   Interventional
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  •   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

The aim of the study is to optimize the safety of pulmonary venin insolation performed by cryogenic or radiofrequency energy with respect to aortic lesions. The endpoint is the detection of aortic lesions after radiofrequency or cryo ablation. The first aortic MRI is planned on the day before ablation and serves as a baseline, then the procedure itself is performed on the following day. The second MRI is performed on the first postoperative day.

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Secondary Outcome

Collection of predictors that favor aortic lesions.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2018/01/01
  •   60
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Included are all patients (> 18 years) undergoing pulmonary vein isolation using radiofrequency energy or cryo-energy within the planned study period of 12 months and agreeing to participate in the study. It is planned to include 60 ablated patients (1: 1, 30 patients with RF ablation and 30 patients with cryoballoon therapy.

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Exclusion Criteria

There should be no contraindications for anticoagulation or magnetic resonance imaging.

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Addresses

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Sources of Monetary or Material Support

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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.