Cryoballoon Pulmonary Venous Isolation in Patients Referred for Typical Atrial Flutter Ablation
Condition: Atrial Flutter; Atrial Fibrillation
MeSH terms: Atrial Fibrillation; Atrial Flutter
Study type: Interventional

Summary: 
      - Background:

      Atrial fibrillation is frequently associated with typical atrial flutter in clinical
      practice. If the radical treatment of atrial flutter by radiofrequency catheter is achieved
      in most cases without recurrence, it does not prevent the occurrence of atrial fibrillation
      that occurs in about 70% of these patients after several years of follow-up. However, the
      latter arrhythmia is associated with significant morbidity and mortality. The problem of
      atrial fibrillation occurrence after successful ablation of typical atrial flutter remains
      physicians primary concern in monitoring these patients.

        -  Objectives:

      The purpose of this study is to demonstrate that the pulmonary veins isolation using balloon
      cryotherapy technology performed at the time of flutter ablation, significantly reduces the
      risk of developing atrial fibrillation in the two year period following the procedure.

        -  Selection Criteria:

      Patients referred for ablation of typical atrial flutter with an history of at least one
      documented episode of atrial fibrillation (atrial flutter remaining the predominant
      arrhythmia)will be enrolled in the study.

        -  Study Methods:

      This is a prospective, multicenter, randomized, 2-arms study, comparing the rate of atrial
      fibrillation occurrence over a two years period following either an ablation procedure of
      typical atrial flutter (Group 1), or a combined procedure of typical atrial flutter ablation
      and pulmonary veins cryoballoon isolation (Group 2). The enrollment period will be of 18
      months.

      Randomization will be 1:1 and will be balanced in blocks of varying size. Patients will then
      be regularly followed up clinically and by long-term ECG recordings.

        -  Evaluation Criteria:

      The primary endpoint will be the recurrence of symptomatic or asymptomatic atrial
      fibrillation, documented by an ECG or an R-test, occurring between M3 and M24

        -  Number of patients:

           170 patients will be enrolled in the study

        -  Number of centers:

      Four French and three German centers will participate.

        -  Perspective:

      The demonstration of a clinical benefit in terms of atrial fibrillation risk reduction in the
      patient group with pulmonary vein isolation, could lead to a modification of atrial
      arrhythmia treatment indication.
    


Intervention name(s): Atrial flutter ablation; Atrial flutter ablation and pulmonary vein isolation
Intervention type(s): Procedure; Procedure
Intervention description(s): Radiofrequency ablation of Atrial flutter; Radiofrequency ablation of atrial flutter and pulmonary vein isolation using cryoablation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Atrial flutter; Atrial fibrillation; Catheter ablation