Cryoballoon Pulmonary Venous Isolation in Patients Referred for Typical Atrial Flutter Ablation (PAF CRIOBLAF)

This study is currently recruiting participants.
Verified September 2012 by University Hospital, Rouen
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT01521988
First received: November 28, 2011
Last updated: September 12, 2012
Last verified: September 2012
  Purpose

- 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.


Condition Intervention
Atrial Flutter
Atrial Fibrillation
Procedure: Atrial flutter ablation
Procedure: Atrial flutter ablation and pulmonary vein isolation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prevention of Atrial Fibrillation by Combined Right Isthmus Ablation and cryoBalloon Pulmonary Vein Isolation in Patients With Typical Atrial Flutter

Resource links provided by NLM:


Further study details as provided by University Hospital, Rouen:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Recurrence rate of typical atrial flutter [ Time Frame: an average of 24 months following the ablation procedure ] [ Designated as safety issue: No ]
    Recurrence rate of typical atrial flutter

  • Rate of occurrence of atypical flutter [ Time Frame: an average of 24 months following the ablation procedure ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    All mortality rate (including sudden death and any type of death)


Estimated Enrollment: 170
Study Start Date: June 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01521988

Contacts
Contact: Frederic Anselme, MD +33 232 888 111 frederic.anselme@chu-rouen.fr
Contact: Arnaud Savoure, MD +33 232 888 111

Locations
France
CHU Grenoble Recruiting
Grenoble, France, 38000
Contact: Pascal DEFAYE, MD    +33476765437    PDefaye@chu-grenoble.fr   
CHU de Rennes Recruiting
Rennes, France, 35033
Contact: Dominique PAVIN, MD    +33 2 99 28 91 83    dominique.pavin@chu-rennes.fr   
University Hospital of Rouen Recruiting
Rouen, France, 76000
Contact: Frederic Anselme, MD    +33 232 888 111    frederic.anselme@chu-rouen.fr   
Contact: Arnaud Savoure, MD    +33 232 888 111    arnaud.savoure@chu-rouen.fr   
Clinique Pasteur Recruiting
Toulouse, France, 31076
Contact: Serge BOVEDA, MD    +33 5 62 21 16 45    s.boveda@clinique-pasteur.com   
Sponsors and Collaborators
University Hospital, Rouen
Medtronic
Investigators
Principal Investigator: Frederic Anselme, MD University Hospital, Rouen
  More Information

No publications provided

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT01521988     History of Changes
Other Study ID Numbers: 2011/089/HP
Study First Received: November 28, 2011
Last Updated: September 12, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Rouen:
Atrial flutter
Atrial fibrillation
Catheter ablation

Additional relevant MeSH terms:
Atrial Fibrillation
Atrial Flutter
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 14, 2014