Clinical trial NCT01521988: Cryoballoon Pulmonary Venous Isolation in Patients Referred for Typical Atrial Flutter Ablation
Official title: Prevention of Atrial Fibrillation by Combined Right Isthmus Ablation and cryoBalloon Pulmonary Vein Isolation in Patients With Typical Atrial Flutter
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Flutter
Atrial Fibrillation
Keywords: Atrial flutter
Atrial fibrillation
Catheter ablation
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2012-01-31
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: * 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

Primary outcomes:
measure: Recurrence of symptomatic or asymptomatic AF as documented on an ECG or a long term Holter
timeFrame: an average of 24 months following the ablation procedure
Secondary outcomes:
measure: Recurrence rate of typical atrial flutter
timeFrame: an average of 24 months following the ablation procedure
measure: Rate of occurrence of atypical flutter
timeFrame: an average of 24 months following the ablation procedure
measure: Rate of occurrence of atrial tachycardia
timeFrame: an average of 24 months following the ablation procedure
measure: Rate of complications related to the ablation procedure
timeFrame: an average of 3 months after the ablation procedure
measure: Rate of major cardiovascular events
timeFrame: an average of 24 months following the ablation procedure
measure: All mortality rate
timeFrame: an average of 24 months following the ablation procedure
Other outcomes:
Locations:
city: Brest
country: France
facility: CHU de Brest
city: Grenoble
country: France
facility: CHU Grenoble
city: La Rochelle
country: France
facility: CH La Rochelle
city: Marseille
country: France
facility: AP-HM - Hôpital Nord
city: Marseille
country: France
facility: Hôpital Privé de Clairval
city: Nantes
country: France
facility: CHU de Nantes
city: Nantes
country: France
facility: Nouvelles Cliniques Nantaises
city: Rennes
country: France
facility: CHU de Rennes
city: Rouen
country: France
facility: University Hospital of Rouen
city: Strasbourg
country: France
facility: CHU de Strasbourg
city: Toulouse
country: France
facility: Clinique Pasteur
city: Tours
country: France
facility: CHU de Tours
city: Tours
country: France
facility: Clinique Saint Gatien
city: Trelaze
country: France
facility: Clinique Saint Joseph
city: Valenciennes
country: France
facility: Polyclinique Vauban
Study officials:
affiliation: University Hospital, Rouen
name: Frederic Anselme, MD
role: PRINCIPAL_INVESTIGATOR
References: