AF Ablation With the Ablation Index

Study Overview
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Brief Summary
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This is an observational multicenter registry of atrial fibrillation catheter ablation performed using the ablation index technology.

Detailed Description
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This is an observational multicenter registry of atrial fibrillation catheter ablation performed using the ablation index technology, which has been introduced as a tool predicting ablation lesion depth. The index incorporates the following characteristics of radiofrequency point-by-point ablation: radiofrequency energy power, contact force, duration of ablation. Since the ablation index is calculated for every individual operator depending on his(her) personal skills, there is no a strict indication on the safe and effective range of the index. This registry aims to evaluate ablation index values used in different centers by different operators. Prospective information on arrhythmia recurrence rate and type, characteristics of redo ablations, characteristics of reconduction ablated areas will be gathered.

Official Title
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A Prospective Registry of Atrial Fibrillation Ablation Using the Prediction of Lesion Depth Technology

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Procedure: Catheter ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: indications for catheter ablation of atrial fibrillation; signed informed consent Exclusion Criteria: Presence of contraindications to AF ablation

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 79 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

| Intervention/Treatment |
| --- |
|Procedure: Catheter ablation|Radiofrequency catheter pulmonary vein isolation|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from atrial fibrillation | Number of participants with no evidence of atrial tachyarrhythmia longer than 30 s in duration at 12 months after ablation, as detected by regular ECG monitoring according to centres' established practices (Holter monitoring every 3 months, implantable loop recorder, cardiac rhythm management device interrogation, other regular ECG screening). Data will be collected using a web-based system with electronic case report forms. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute complications | Number of participants with adverse events that are related to treatment (i.e. cardiac tamponade, periprocedural stroke, pulmonary vein stenosis, esophageal damage, etc) whithin 30 days after ablation. Data will be collected using a web-based system with electronic case report forms. | 30 days | 
| Procedure time | Duration of the total ablation procedure and fluoroscopy needed to complete pulmonary vein isolation, expressed in minutes. | 180 minutes | 
| Fluoroscopy time | Fluoroscopy duration within the procedure | 24 hours | 
| Electrical reconduction | Number of participats with electrical reconduction into pulmonary veins as assessed during repeat procedures. | 2 years |