Benefit of Left Atrial Roof Ablation in Paroxysmal Atrial Fibrillation

Study Overview
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Brief Summary
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The aim of the present study is to assess whether left atrial roof ablation adds any benefit in the arrhythmia-free probability after paroxysmal atrial fibrillation ablation.

Conditions
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Drug-refractory Paroxysmal Atrial Fibrillation

Intervention / Treatment
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* Procedure: Pulmonary vein encircling
* Procedure: Pulmonary vein encircling plus roof ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Drug-refractory paroxysmal atrial fibrillation Exclusion Criteria: Hypo or hyperthyroidism Implantable defibrillation or pacemaker implanted Moderate or severe mitral valve disease or mitral prosthetic valve Ejection fraction less than 30% Left atrial anteroposterior diameter more than 50 mm. Previous atrial fibrillation ablation Left atrium thrombus Current infective disease or sepsis Pregnant women Current unstable angor Acute myocardial infarction in last 3 months Atrial fibrillation secondary to ionic disturbance, thyroids disease or secondary to any other reversible or non cardiovascular disease Reduced expectancy of life (less than 12 months) Patient participating in another clinical study that investigates a drug or device Psychologically unstable patient or denies to give informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional ablation<br>Pulmonary vein encircling by performing continuous radiofrequency lesions surrounding each ipsilateral pulmonary vein antrum | Procedure: Pulmonary vein encircling<br>* Pulmonary vein encircling by performing continuous radiofrequency lesions surrounding each ipsilateral pulmonary vein antrum<br>|
| Active Comparator: Conventional ablation plus left atrial roof ablation<br>Pulmonary vein encircling by performing continuous radiofrequency lesions surrounding each ipsilateral pulmonary vein antrum plus creation of a radiofrequency line joining contralateral superior pulmonary veins throughout the left atrial roof. | Procedure: Pulmonary vein encircling plus roof ablation<br>* Pulmonary vein encircling by performing continuous radiofrequency lesions surrounding each ipsilateral pulmonary vein antrum plus creation of a radiofrequency line joining contralateral superior pulmonary veins throughout the left atrial roof.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from atrial arrhythmias without antiarrhythmic drugs |  | 1-year follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from atrial arrhythmias with or without antiarrhythmic drugs |  | 1-year follow-up | 
| Presence of any complications in the acute phase or during follow-up |  | 1-year follow-up |