Clinical Trial Details

NCT ID: NCT01521988
Date Last Changed: September 14, 2015


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

  • 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.

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Recruitment Details

Both Male and Female
18 to 75 Years
Overall Status
Lead Sponsor
University Hospital, Rouen
70 Months
Facility Type


Both Male and Female ages 18 Years to 75 Years

  • Inclusion Criteria:

  • Patient with a spontaneous flutter or with a flutter recurrence when it was not considered appropriate to use a preventive treatment so far. The flutter may have been paroxysmal or may still be present.

  • Patient with at least one documented episode of typical flutter defined as follows: negative F waves in the inferior territory, positive in V1 and negative in V6 lead, F wave pattern with characteristic "saw tooth" appearance and finally a heart rate comprised between 240 and 320 beats per minute.

  • Patient with effective anticoagulant therapy for at least 3 weeks.

  • Patient with at least one episode of AF (lasting more than 1 minute) documented on an ECG or a 24 hour Holter recording

  • Patient who signed an informed consent.

  • Patient with age ≥ 18 yo and ≤ 75 yo

  • Exclusion Criteria:

  • Patients with the following characteristics will be excluded:

  • Contraindication to right-heart catheterization

  • Contraindication to an anticoagulant treatment

  • Patient for which AF is predominant (more recordings of AF than Flutter)

  • Persistent AF at the time of inclusion visit

  • History of mitral valve surgery

  • Known disorders of blood clotting

  • Cardiothyreosis

  • Life expectancy < 24 months

  • Less than 18 years old and pregnant ladies. As before any ablation, a pregnancy test will be done the day before or the day of the procedure

  • Patient less than 18 years old

  • Patient under guardianship

  • Patient deprived of their liberty by a court decision

Site Locations (15)

Country State City Zip Facility and Contact
France Brest CHU de Brest
France Grenoble 38000 CHU Grenoble
France La Rochelle CH La Rochelle
Antoine MILHEM
France Marseille AP-HM - Hôpital Nord
Mickael PEYROL, MD
France Marseille Hôpital Privé de Clairval
France Nantes CHU de Nantes
Gilles LANDE, MD
France Nantes Nouvelles Cliniques Nantaises
Jean-Pierre CEBRON, MD
France Rennes 35033 CHU de Rennes
Dominique PAVIN, MD
+33 2 99 28 91 83
France Rouen 76000 University Hospital of Rouen
Frederic Anselme, MD
+33 232 888 111
France Strasbourg CHU de Strasbourg
Laurence JESEL, MD
France Toulouse 31076 Clinique Pasteur
+33 5 62 21 16 45
France Tours CHU de Tours
Dominique BABUTY, Pr
France Tours Clinique Saint Gatien
Olivier CESARI, MD
France Trelaze Clinique Saint Joseph
Frédéric Treguer, MD
France Valenciennes Polyclinique Vauban
Philippe RIVAT


Frederic Anselme, MD
+33 232 888 111

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