Cryoballoon Pulmonary Venous Isolation in Patients Referred for Typical Atrial Flutter Ablation (PAF CRIOBLAF)
Primary Purpose
Atrial Flutter, Atrial Fibrillation
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Atrial flutter ablation
Atrial flutter ablation and pulmonary vein isolation
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Flutter focused on measuring Atrial flutter, Atrial fibrillation, Catheter ablation
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
Sites / Locations
- CHU de Brest
- CHU Grenoble
- CH La Rochelle
- AP-HM - Hôpital Nord
- Hôpital Privé de Clairval
- CHU de Nantes
- Nouvelles Cliniques Nantaises
- CHU de Rennes
- University Hospital of Rouen
- CHU de Strasbourg
- Clinique Pasteur
- CHU de Tours
- Clinique Saint Gatien
- Clinique Saint Joseph
- Polyclinique Vauban
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Atrial flutter ablation
Atrial flutter ablation and pulmonary vein isolation
Arm Description
RF atrial flutter ablation
RF Atrial flutter ablation and pulmonary vein isolation using cryoablation
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Recurrence rate of typical atrial flutter
Recurrence rate of typical atrial flutter
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
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
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
Rate of major cardiovascular events
Rate of major cardiovascular events such as rehospitalization for arrhythmia, heart failure, or embolic accident
All mortality rate
All mortality rate (including sudden death and any type of death)
Full Information
NCT ID
NCT01521988
First Posted
November 28, 2011
Last Updated
May 25, 2018
Sponsor
University Hospital, Rouen
Collaborators
Medtronic
1. Study Identification
Unique Protocol Identification Number
NCT01521988
Brief Title
Cryoballoon Pulmonary Venous Isolation in Patients Referred for Typical Atrial Flutter Ablation
Acronym
PAF CRIOBLAF
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
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
June 2012 (Actual)
Primary Completion Date
April 2018 (Actual)
Study Completion Date
April 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Rouen
Collaborators
Medtronic
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Flutter, Atrial Fibrillation
Keywords
Atrial flutter, Atrial fibrillation, Catheter ablation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
76 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Atrial flutter ablation
Arm Type
Active Comparator
Arm Description
RF atrial flutter ablation
Arm Title
Atrial flutter ablation and pulmonary vein isolation
Arm Type
Experimental
Arm Description
RF Atrial flutter ablation and pulmonary vein isolation using cryoablation
Intervention Type
Procedure
Intervention Name(s)
Atrial flutter ablation
Intervention Description
Radiofrequency ablation of Atrial flutter
Intervention Type
Procedure
Intervention Name(s)
Atrial flutter ablation and pulmonary vein isolation
Intervention Description
Radiofrequency ablation of atrial flutter and pulmonary vein isolation using cryoablation
Primary Outcome Measure Information:
Title
Recurrence of symptomatic or asymptomatic AF as documented on an ECG or a long term Holter
Description
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.
Time Frame
an average of 24 months following the ablation procedure
Secondary Outcome Measure Information:
Title
Recurrence rate of typical atrial flutter
Description
Recurrence rate of typical atrial flutter
Time Frame
an average of 24 months following the ablation procedure
Title
Rate of occurrence of atypical flutter
Description
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
Time Frame
an average of 24 months following the ablation procedure
Title
Rate of occurrence of atrial tachycardia
Description
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
Time Frame
an average of 24 months following the ablation procedure
Title
Rate of complications related to the ablation procedure
Description
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
Time Frame
an average of 3 months after the ablation procedure
Title
Rate of major cardiovascular events
Description
Rate of major cardiovascular events such as rehospitalization for arrhythmia, heart failure, or embolic accident
Time Frame
an average of 24 months following the ablation procedure
Title
All mortality rate
Description
All mortality rate (including sudden death and any type of death)
Time Frame
an average of 24 months following the ablation procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frederic Anselme, MD
Organizational Affiliation
University Hospital, Rouen
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Brest
City
Brest
Country
France
Facility Name
CHU Grenoble
City
Grenoble
ZIP/Postal Code
38000
Country
France
Facility Name
CH La Rochelle
City
La Rochelle
Country
France
Facility Name
AP-HM - Hôpital Nord
City
Marseille
Country
France
Facility Name
Hôpital Privé de Clairval
City
Marseille
Country
France
Facility Name
CHU de Nantes
City
Nantes
Country
France
Facility Name
Nouvelles Cliniques Nantaises
City
Nantes
Country
France
Facility Name
CHU de Rennes
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
University Hospital of Rouen
City
Rouen
ZIP/Postal Code
76000
Country
France
Facility Name
CHU de Strasbourg
City
Strasbourg
Country
France
Facility Name
Clinique Pasteur
City
Toulouse
ZIP/Postal Code
31076
Country
France
Facility Name
CHU de Tours
City
Tours
Country
France
Facility Name
Clinique Saint Gatien
City
Tours
Country
France
Facility Name
Clinique Saint Joseph
City
Trelaze
Country
France
Facility Name
Polyclinique Vauban
City
Valenciennes
Country
France
12. IPD Sharing Statement
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Cryoballoon Pulmonary Venous Isolation in Patients Referred for Typical Atrial Flutter Ablation
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