Cryoballoon Pulmonary Venous Isolation in Patients Referred for Typical Atrial Flutter Ablation (PAF CRIOBLAF)
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|ClinicalTrials.gov Identifier: NCT01521988|
Recruitment Status : Completed
First Posted : January 31, 2012
Last Update Posted : May 28, 2018
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.
- 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.
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.
|Condition or disease||Intervention/treatment||Phase|
|Atrial Flutter Atrial Fibrillation||Procedure: Atrial flutter ablation Procedure: Atrial flutter ablation and pulmonary vein isolation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||76 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prevention of Atrial Fibrillation by Combined Right Isthmus Ablation and cryoBalloon Pulmonary Vein Isolation in Patients With Typical Atrial Flutter|
|Actual Study Start Date :||June 2012|
|Actual Primary Completion Date :||April 2018|
|Actual Study Completion Date :||April 2018|
Active Comparator: Atrial flutter ablation
RF atrial flutter ablation
Procedure: Atrial flutter ablation
Radiofrequency ablation of Atrial flutter
Experimental: Atrial flutter ablation and pulmonary vein isolation
RF Atrial flutter ablation and pulmonary vein isolation using cryoablation
Procedure: Atrial flutter ablation and pulmonary vein isolation
Radiofrequency ablation of atrial flutter and pulmonary vein isolation using cryoablation
- Recurrence of symptomatic or asymptomatic AF as documented on an ECG or a long term Holter [ Time Frame: an average of 24 months following the ablation procedure ]Main endpoint will be the recurrence of symptomatic or asymptomatic atrial fibrillation as documented by an ECG or a R-test. Sustained AF episodes of more than a minute will be classified depending if they are symptomatic or not.
- Recurrence rate of typical atrial flutter [ Time Frame: an average of 24 months following the ablation procedure ]Recurrence rate of typical atrial flutter
- Rate of occurrence of atypical flutter [ Time Frame: an average of 24 months following the ablation procedure ]Occurrence rate of atypical flutter defined as a continuous atrial activity (with no return to the isoelectric line)in at least one lead, whose ECG appearance of F waves is different from that of a typical flutter
- Rate of occurrence of atrial tachycardia [ Time Frame: an average of 24 months following the ablation procedure ]Rate of occurrence of atrial tachycardia defined as an atrial activaty that generates a P wave with return to the isoelectric line in all leads
- Rate of complications related to the ablation procedure [ Time Frame: an average of 3 months after the ablation procedure ]
The following complications will be considered:
Hematoma at punction site, Thromboembolic accident, Tamponnade, Phrenic nerve paralysis, Symptomatic stenosis of pulmonary vein, Atrio-ventricular block Atrioesophageal fistula
- Rate of major cardiovascular events [ Time Frame: an average of 24 months following the ablation procedure ]Rate of major cardiovascular events such as rehospitalization for arrhythmia, heart failure, or embolic accident
- All mortality rate [ Time Frame: an average of 24 months following the ablation procedure ]All mortality rate (including sudden death and any type of death)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01521988
|CHU de Brest|
|Grenoble, France, 38000|
|CH La Rochelle|
|La Rochelle, France|
|AP-HM - Hôpital Nord|
|Hôpital Privé de Clairval|
|CHU de Nantes|
|Nouvelles Cliniques Nantaises|
|CHU de Rennes|
|Rennes, France, 35033|
|University Hospital of Rouen|
|Rouen, France, 76000|
|CHU de Strasbourg|
|Toulouse, France, 31076|
|CHU de Tours|
|Clinique Saint Gatien|
|Clinique Saint Joseph|
|Principal Investigator:||Frederic Anselme, MD||University Hospital, Rouen|