Cryoballoon Pulmonary Venous Isolation in Patients Referred for Typical Atrial Flutter Ablation

Atrial Fibrillation Clinical Trial

— PAF CRIOBLAF  

Official title:

Prevention of Atrial Fibrillation by Combined Right Isthmus Ablation and cryoBalloon Pulmonary Vein Isolation in Patients With Typical Atrial Flutter

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01521988
• Other study ID #: 2011/089/HP
• Status: Completed
• Phase: N/A
• Start date: June 2012
• Est. completion date: April 2018

Study information

• Verified date: May 2018
• Source: University Hospital, Rouen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: April 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

• 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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Flutter

Intervention

Procedure:
• Atrial flutter ablation
Radiofrequency ablation of Atrial flutter
• Atrial flutter ablation and pulmonary vein isolation
Radiofrequency ablation of atrial flutter and pulmonary vein isolation using cryoablation

Locations

Country	Name	City	State
France	CHU de Brest	Brest
France	CHU Grenoble	Grenoble
France	CH La Rochelle	La Rochelle
France	AP-HM - Hôpital Nord	Marseille
France	Hôpital Privé de Clairval	Marseille
France	CHU de Nantes	Nantes
France	Nouvelles Cliniques Nantaises	Nantes
France	CHU de Rennes	Rennes
France	University Hospital of Rouen	Rouen
France	CHU de Strasbourg	Strasbourg
France	Clinique Pasteur	Toulouse
France	CHU de Tours	Tours
France	Clinique Saint Gatien	Tours
France	Clinique Saint Joseph	Trelaze
France	Polyclinique Vauban	Valenciennes

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Rouen	Medtronic

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence of symptomatic or asymptomatic AF as documented on an ECG or a long term Holter	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.	an average of 24 months following the ablation procedure
Secondary	Recurrence rate of typical atrial flutter	Recurrence rate of typical atrial flutter	an average of 24 months following the ablation procedure
Secondary	Rate of occurrence of atypical flutter	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	an average of 24 months following the ablation procedure
Secondary	Rate of occurrence of atrial tachycardia	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	an average of 24 months following the ablation procedure
Secondary	Rate of complications related to 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	an average of 3 months after the ablation procedure
Secondary	Rate of major cardiovascular events	Rate of major cardiovascular events such as rehospitalization for arrhythmia, heart failure, or embolic accident	an average of 24 months following the ablation procedure
Secondary	All mortality rate	All mortality rate (including sudden death and any type of death)	an average of 24 months following the ablation procedure