Clinical Prognosis of Patients With Atrial Fibrillation During Radiofrequency Ablation

Study Overview
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Brief Summary
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This study is an ancillary study to Isochrone-AF. The investigators hypothesize that patients eligible but non-included in the primary study (patients classified as non-reducible or non-inducible) will have different prognosis and electro-physiclogical characteristics to the patients included and randomized into the Isochrone AF study.

Official Title
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Clinical Prognosis of Patients With Atrial Fibrillation During Radiofrequency Ablation and Interest of the Isochron Map

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Procedure: Wide antrum circle ablation
* Procedure: External electric cardioversion


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 is available for 18 month follow-up The patient has paroxysmal or persistent atrial fibrillation 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 Early Study Exit Criteria: Patient does not have paroxysmal or persistent AF at the time of inclusion

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with sinus rhythm<br> | Procedure: Wide antrum circle ablation<br>* As standard hospital policy<br>|
| patients with atrial fibrillation<br> | Procedure: External electric cardioversion<br>* Three attempts (200-250 joules)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Atrial fibrillation relapse in non-reducible or non-inducible patients | Atrial fibrillation detected by routine or event-associated Holter examination | Month 18 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Atrial fibrillation relapse in non-reducible or non-inducible patients | Atrial fibrillation detected by routine or event-associated Holter examination | Month 12 | 
| Arrhythmia occurrence in non-reducible or non-inducible patients | Arrhythmia, including atrial tachycardia detected by routine or event-associated Holter examination | Month 12 | 
| Arrhythmia occurrence in non-reducible or non-inducible patients | Arrhythmia, including atrial tachycardia detected by routine or event-associated Holter examination | Month 18 | 
| Identification of zones of low voltage on voltage maps in non-inducible patients | Yes/No | Day 0 | 
| Identification of zones of anisochronic zones on voltage maps in non-inducible patients | Yes/No | Day 0 | 
| Maximum variation of conduction speed in the same anatomic region in non-inducible patients |  | Day 0 | 
| Decreasing velocities in the same anatomic region in non-inducible patients |  | Day 0 | 
| Wave front rotation in the same anatomic region in non-inducible patients | degrees | Day 0 | 
| Total time of radiofrequency in non-inducible patients | Minutes | Day 0 | 
| Total procedure time in non-inducible patients | Minutes | Day 0 | 
| Comparison of lesion volume in non-inducible patients | Force-time integral, lesion size index or stroke volume index | Day 0 | 
| Number and size of treated zones by guided versus conventional ablation in non-inducible patients | cm2 | Day 0 | 
| List locations most frequently treated | Number of each | Day 0 | 
| Survival without relapse of patients treated using the Carto- vs Rhythmia-guided ablation approaches in non-reducible or non-inducible patients | Atrial fibrillation detected by routine or event-associated Holter examination | Month 18 | 
| Arrhythmia occurrence in non-reducible or non-inducible patients | Atrial fibrillation detected by routine or event-associated Holter examination | Month 18 |