Trial document




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  DRKS00017011

Trial Description

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Title

Randomised comparison of two ablation index-based protocols for pulmonary vein isolation

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Electrical isolation of the pulmonary veins by radiofrequency ablation is a well established therapy in patients with atrial fibrillation. In this method, a continous ablation line is generated through sequences of ablation points ("point by point ablation"). However, it has been challenging to establish long-lasting lines without gaps and with sufficient lesion depth for any given point. In recent years great progress has been made to standardize the procedure using indeces that reflect lesion depth and extent of ablation. Based on these indeces standardised ablation protocols have been developed and validated. However the optimal distance between two neighbouring ablation points ("interlesion distance") has not been precisely defined. Some protocols propose interlesion distances of 6mm or less, while others use substantially lower boundaries. This trial aims two compare two different ablation index-based protocols used in clinical practice with interlesion distances of 3-4mm and 5-6mm, respectively. If the pulmonary veins are not isolated upon a first attempt with a given protocol, isolation will be completed by additional ablation irrespective of the protocol. Thus, procedural success will be warranted for every patient, irrespective of the study group.

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Brief Summary in Scientific Language

For pulmonary vein isolation using point by point radiofrequency ablation based on ablation index interlesion distances of 6 mm or less have been proposed. However, a precise target interlesion distance has not been defined. Here we will randomly assign patients to target interlesion distances of either 3-4 mm or 5-6 mm. Primary endpoint of the study will be the percentage of first pass pulmonary vein isolation.

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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

  •   DRKS00017011
  •   2019/03/21
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  •   yes
  •   Approved
  •   EA4/187/18, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

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Health Condition or Problem studied

  •   I48.0 -  Paroxysmal atrial fibrillation
  •   I48.1 -  Persistent atrial fibrillation
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Interventions/Observational Groups

  •   Ablation protocol A
    - Target ILD 5-6 mm
    - Target Ablation Index anterior wall min. 550
    - Target Ablation Index posterior wall min. 400
  •   Ablation protocol B
    - Target ILD 3-4 mm
    - Target Ablation Index anterior wall min. 500
    - Target Ablation Index posterior wall min. 350
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Percentage of successful pulmonary vein isolation upon first attempt (first pass pulmonary vein isolation)

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Secondary Outcome

a) Successful pulmonary vein Isolation (procedural success)
b) Pulmonary vein reconnection at redo procedure
c) Recurrence rates and burden of atrial fibrillation

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2019/03/21
  •   114
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

Indication for pulmonary vein Isolation (first procedure)

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Exclusion Criteria

Age below 18, pregnancy

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Addresses

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    • Charité Campus Charité Mitte
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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    • Martin Luther-Krankenhaus Berlin, Kardiologie
    • Mr.  Dr. med.  Ivan  Diaz Ramirez 
    • Caspar-Theyß-Straße 27-31
    • 14193  Berlin
    • Germany
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    • Charité - Universitätsmedizin Berlin, Klinik für Kardiologie und Angiologie, Charité Campus Mitte
    • Mr.  Dr. med.  Till  Althoff 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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    • Charité - Universitätsmedizin Berlin, Klinik für Kardiologie und Angiologie, Charité Campus Mitte
    • Mr.  Dr. med.  Till  Althoff 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Charité Campus Charité Mitte
    • Charitéplatz 1
    • 10117  Berlin
    • 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.