Research Study Summary
Patients are needed to participate in a clinical research study evaluating Atrial flutter ablation and Atrial flutter ablation and pulmonary vein isolation for the treatment of Atrial Flutter or Atrial Fibrillation
Research Study Title
Prevention of Atrial Fibrillation by Combined Right Isthmus Ablation and cryoBalloon Pulmonary Vein Isolation in Patients With Typical Atrial Flutter
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.
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.
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.
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
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.
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
170 patients will be enrolled in the study
Four French and three German centers will participate.
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.
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