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

May 25, 2018 updated by: University Hospital, Rouen

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

76

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Brest, France
        • CHU de Brest
      • Grenoble, France, 38000
        • CHU Grenoble
      • La Rochelle, France
        • CH La Rochelle
      • Marseille, France
        • AP-HM - Hôpital Nord
      • Marseille, France
        • Hôpital privé de Clairval
      • Nantes, France
        • CHU de Nantes
      • Nantes, France
        • Nouvelles Cliniques Nantaises
      • Rennes, France, 35033
        • CHU de Rennes
      • Rouen, France, 76000
        • University Hospital of Rouen
      • Strasbourg, France
        • CHU de Strasbourg
      • Toulouse, France, 31076
        • Clinique Pasteur
      • Tours, France
        • CHU de Tours
      • Tours, France
        • Clinique Saint Gatien
      • Trelaze, France
        • Clinique Saint Joseph
      • Valenciennes, France
        • Polyclinique Vauban

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Atrial flutter ablation
RF 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
Radiofrequency ablation of atrial flutter and pulmonary vein isolation using cryoablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
an average of 24 months following the ablation procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence rate of typical atrial flutter
Time Frame: an average of 24 months following the ablation procedure
Recurrence rate of typical atrial flutter
an average of 24 months following the ablation procedure
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
an average of 24 months following the ablation procedure
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
an average of 24 months following the ablation procedure
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

an average of 3 months after the ablation procedure
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
an average of 24 months following the ablation procedure
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)
an average of 24 months following the ablation procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Frederic Anselme, MD, University Hospital, Rouen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2012

Primary Completion (Actual)

April 1, 2018

Study Completion (Actual)

April 1, 2018

Study Registration Dates

First Submitted

November 28, 2011

First Submitted That Met QC Criteria

January 26, 2012

First Posted (Estimate)

January 31, 2012

Study Record Updates

Last Update Posted (Actual)

May 29, 2018

Last Update Submitted That Met QC Criteria

May 25, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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