Substrate Ablation Guided by High Density Mapping in Atrial Fibrillation

Study Overview
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Brief Summary
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To evaluate a new AF Substrate mapping method based on automatic high density CFAE detection with a multipolar catheter (Pentaray) and the  SCI 30-40  setting of CARTO CFAE algorithm.

Detailed Description
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This study is observational : This substrate ablation method is performed routinely in the centers involved in the study so, patients were not assigned by the investigators to undergo a specific procedure because of the study, in all cases patient would have beneficiate from this substrate mapping ablation method. We assessed procedural and follow up outcomes of this subatrate ablation group and compared them with an historical control group undergoing conventional ablation.

Official Title
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Substrate Ablation Guided by Automatic High Density Mapping for the Treatment of Atrial Fibrillation

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Procedure: Routine substrate ablation without pulmonary vein Isolation
* Procedure: Routine conventional ablation with pulmonary vein Isolation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient from 18 to 85, with AF* (paroxysmal, and persistent AF) and indication of AF ablation (including redos)* *In accordance with the recommendation of European Society of Cardiology (2010). Exclusion Criteria: organized atrial activity (Atrial tachycardia or Flutter)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- |
| Studied<br>Between September 2013 and July 2014, 105 patients were enrolled in 3 centers performing routinely Atrial Fibrillation ablation guided by spatio-temporal electrogram dispersion without pulmonary vein Isolation | Procedure: Routine substrate ablation without pulmonary vein Isolation<br> <br> |
| Control<br>The validation set included a cohort of 47 patients with symptomatic drug-refractory AF who underwent ablation using a conventional approach. | Procedure: Routine conventional ablation with pulmonary vein Isolation<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patient With Atrial Fibrillation Termination at the End of the Procedure | percentage of patient in sinus rhythm or in atrial tachycardia at the end of the procedure | up to 240 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % of Patients With Sinus Rhythm Conversion During the Procedure |  | 180 min | 
| Radiofrequency Time (Min) |  | up to 300 min | 
| Percentage of Patients Free From Atrial Fibrillation 18 Months Post Ablation | % of patients in sinus rhythm or in atrial tachycardia assessed by ECG and/ot 24h-Holter monitoring and clinical examination during follow-up. | 18 Months post ablation | 
| Number of Patients With Major Adverse Events During and up to 18 Months After Procedure | Adverse events | 18 months post ablation | 
| Maximum Sustained AF Duration | duration of the longest AF epiodes in months before ablation | from first AF episode to baseline | 
| Mean LA Volume | Left Atrial volume before ablation in ml | baseline | 
| Spontaneous AF at the Beginning of the Procedure | Spontaneous AF at the beginning of the procedure | baseline |