Back to resultsAblation of Anisochronous Zones vs Spatio-temporal Dispersal Zones With Antral Electrical Isolation During Radiofrequency Treatment of Paroxysmal or Persistent Atrial Fibrillation (ISOCHRONE-AF)
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Atrial fibrillation ablation
Atrial fibrillation ablation
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation
Eligibility Criteria
Inclusion Criteria:
- The patient must have given their free and informed consent and signed the consent form
- The patient must be a member or beneficiary of a health insurance plan
- The patient is at least 18 years old
- The patient has paroxysmal or persistent atrial fibrillation
- The patient is available for 18 month follow-up
Exclusion Criteria:
- The subject is participating in a category 1 interventional study, or is in a period of exclusion determined by a previous study
- The subject refuses to sign the consent
- It is impossible to give the subject informed information
- The patient is under safeguard of justice or state guardianship
- The patient is pregnant or breastfeeding
- Sinus rhythm has not been able to be determined using external electric cardioversion
- Patient not susceptible to atrial fibrillation following wide antrum circle ablation
- The subject has already been included in the study (patients cannot be included more than once)
Sites / Locations
- CHU Montpellier
- CHU Nimes
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control
Isochrone
Arm Description
ablation of Atrial fibrillation using spatio-temporal dispersion
ablation of concordance zones using isochrone and voltage maps
Outcomes
Primary Outcome Measures
Atrial fibrillation relapse between groups
Atrial fibrillation detected by routine or event-associated Holter examination
Secondary Outcome Measures
Atrial fibrillation relapse between groups
Atrial fibrillation detected by routine or event-associated Holter examination
Arrhythmia occurrence between groups
Arrhythmia, including atrial tachycardia detected by routine or event-associated Holter examination
Arrhythmia occurrence between groups
Arrhythmia, including atrial tachycardia detected by routine or event-associated Holter examination
Concordance of isochrone and voltage maps
Binary yes/no
Maximum variation of conduction speed between variation healthy zones with anisochronic zones in the same anatomic region
Comparison of the decreasing velocities between healthy zones and anisochronic zones in the same anatomic region
Comparison of wave front rotation between healthy zones and anisochronic zones in the same anatomic region
degrees
Total time of radiofrequency between groups
Minutes
Comparison of lesion volume between groups
Force-time integral, lesion size index or stroke volume index
Total procedure time between groups
Minutes
Number of treated zones between groups
Size of treated zones between groups
cm2
List locations most frequently treated
Number of each
Survival without relapse of the subgroups paroxysmal versus persistent atrial fibrillation.
Atrial fibrillation detected by routine or event-associated Holter examination
Survival without relapse of the subgroups treated using the Carto- vs Rhythmia-guided ablation approaches.
Atrial fibrillation detected by routine or event-associated Holter examination
Full Information
NCT ID
NCT03564951
First Posted
June 11, 2018
Last Updated
September 15, 2020
Sponsor
Centre Hospitalier Universitaire de Nīmes
1. Study Identification
Unique Protocol Identification Number
NCT03564951
Brief Title
Ablation of Anisochronous Zones vs Spatio-temporal Dispersal Zones With Antral Electrical Isolation During Radiofrequency Treatment of Paroxysmal or Persistent Atrial Fibrillation
Acronym
ISOCHRONE-AF
Official Title
Comparison of Ablation of Anisochronous Zones vs Spatio-temporal Dispersal Zones in Addition to Antral Electrical Isolation During Radiofrequency Treatment of Paroxysmal or Persistent Atrial Fibrillation
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
February 14, 2019 (Actual)
Primary Completion Date
August 19, 2020 (Actual)
Study Completion Date
August 19, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Using isochronous maps during radiofrequency ablation procedures may identify the driver zones responsible for atrial fibrillation maintenance with greater accuracy compared to a conventional procedure (simple antral isolation of the associated pulmonary veins or, if necessary, combined with removal of spatio-temporal dispersal zones) that do not use isochronous maps, and thus improve the efficiency and safety of atrial fibrillation treatment by radiofrequency treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Active Comparator
Arm Description
ablation of Atrial fibrillation using spatio-temporal dispersion
Arm Title
Isochrone
Arm Type
Experimental
Arm Description
ablation of concordance zones using isochrone and voltage maps
Intervention Type
Procedure
Intervention Name(s)
Atrial fibrillation ablation
Intervention Description
ablation of Atrial fibrillation using spatio-temporal dispersion
Intervention Type
Procedure
Intervention Name(s)
Atrial fibrillation ablation
Intervention Description
ablation of concordance zones using isochrone and voltage maps
Primary Outcome Measure Information:
Title
Atrial fibrillation relapse between groups
Description
Atrial fibrillation detected by routine or event-associated Holter examination
Time Frame
Month 18
Secondary Outcome Measure Information:
Title
Atrial fibrillation relapse between groups
Description
Atrial fibrillation detected by routine or event-associated Holter examination
Time Frame
Month 12
Title
Arrhythmia occurrence between groups
Description
Arrhythmia, including atrial tachycardia detected by routine or event-associated Holter examination
Time Frame
Month 12
Title
Arrhythmia occurrence between groups
Description
Arrhythmia, including atrial tachycardia detected by routine or event-associated Holter examination
Time Frame
Month 18
Title
Concordance of isochrone and voltage maps
Description
Binary yes/no
Time Frame
Day 0
Title
Maximum variation of conduction speed between variation healthy zones with anisochronic zones in the same anatomic region
Time Frame
Day 0
Title
Comparison of the decreasing velocities between healthy zones and anisochronic zones in the same anatomic region
Time Frame
Day 0
Title
Comparison of wave front rotation between healthy zones and anisochronic zones in the same anatomic region
Description
degrees
Time Frame
Day 0
Title
Total time of radiofrequency between groups
Description
Minutes
Time Frame
Day 0
Title
Comparison of lesion volume between groups
Description
Force-time integral, lesion size index or stroke volume index
Time Frame
Day 0
Title
Total procedure time between groups
Description
Minutes
Time Frame
Day 0
Title
Number of treated zones between groups
Time Frame
Day 0
Title
Size of treated zones between groups
Description
cm2
Time Frame
Day 0
Title
List locations most frequently treated
Description
Number of each
Time Frame
Day 0
Title
Survival without relapse of the subgroups paroxysmal versus persistent atrial fibrillation.
Description
Atrial fibrillation detected by routine or event-associated Holter examination
Time Frame
Month 18
Title
Survival without relapse of the subgroups treated using the Carto- vs Rhythmia-guided ablation approaches.
Description
Atrial fibrillation detected by routine or event-associated Holter examination
Time Frame
Month 18
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The patient must have given their free and informed consent and signed the consent form
The patient must be a member or beneficiary of a health insurance plan
The patient is at least 18 years old
The patient has paroxysmal or persistent atrial fibrillation
The patient is available for 18 month follow-up
Exclusion Criteria:
The subject is participating in a category 1 interventional study, or is in a period of exclusion determined by a previous study
The subject refuses to sign the consent
It is impossible to give the subject informed information
The patient is under safeguard of justice or state guardianship
The patient is pregnant or breastfeeding
Sinus rhythm has not been able to be determined using external electric cardioversion
Patient not susceptible to atrial fibrillation following wide antrum circle ablation
The subject has already been included in the study (patients cannot be included more than once)
Facility Information:
Facility Name
CHU Montpellier
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
CHU Nimes
City
Nîmes
ZIP/Postal Code
30029
Country
France
12. IPD Sharing Statement
Learn more about this trial
Ablation of Anisochronous Zones vs Spatio-temporal Dispersal Zones With Antral Electrical Isolation During Radiofrequency Treatment of Paroxysmal or Persistent Atrial Fibrillation
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