Ablation of Anisochronous Zones vs Spatio-temporal Dispersal Zones With Antral Electrical Isolation During Radiofrequency Treatment of Paroxysmal or Persistent Atrial Fibrillation

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Procedure: Atrial fibrillation ablation
* Procedure: Atrial fibrillation ablation


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>ablation of Atrial fibrillation using spatio-temporal dispersion | Procedure: Atrial fibrillation ablation<br>* ablation of Atrial fibrillation using spatio-temporal dispersion<br>|
| Experimental: Isochrone<br>ablation of concordance zones using isochrone and voltage maps | Procedure: Atrial fibrillation ablation<br>* ablation of concordance zones using isochrone and voltage maps<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Atrial fibrillation relapse between groups | Atrial fibrillation detected by routine or event-associated Holter examination | Month 18 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Atrial fibrillation relapse between groups | Atrial fibrillation detected by routine or event-associated Holter examination | Month 12 | 
| Arrhythmia occurrence between groups | Arrhythmia, including atrial tachycardia detected by routine or event-associated Holter examination | Month 12 | 
| Arrhythmia occurrence between groups | Arrhythmia, including atrial tachycardia detected by routine or event-associated Holter examination | Month 18 | 
| Concordance of isochrone and voltage maps | Binary yes/no | Day 0 | 
| Maximum variation of conduction speed between variation healthy zones with anisochronic zones in the same anatomic region |  | Day 0 | 
| Comparison of the decreasing velocities between healthy zones and anisochronic zones in the same anatomic region |  | Day 0 | 
| Comparison of wave front rotation between healthy zones and anisochronic zones in the same anatomic region | degrees | Day 0 | 
| Total time of radiofrequency between groups | Minutes | Day 0 | 
| Comparison of lesion volume between groups | Force-time integral, lesion size index or stroke volume index | Day 0 | 
| Total procedure time between groups | Minutes | Day 0 | 
| Number of treated zones between groups |  | Day 0 | 
| Size of treated zones between groups | cm2 | Day 0 | 
| List locations most frequently treated | Number of each | Day 0 | 
| Survival without relapse of the subgroups paroxysmal versus persistent atrial fibrillation. | Atrial fibrillation detected by routine or event-associated Holter examination | Month 18 | 
| 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 | Month 18 |