Study of Ablation Versus antiaRrhythmic Drugs in Persistent Atrial Fibrillation

Study Overview
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Brief Summary
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The purpose of this study is to compare the effectivity and safety of atrial fibrillation ablation, in comparison to antiarrhythmic drug therapy in patients with refractory, persistent atrial fibrillation.

Official Title
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Study of Ablation Versus antiaRrhythmic Drugs in Persistent Atrial Fibrillation

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Procedure: Atrial fibrillation ablation
* Drug: Antiarrhythmic drug


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with persistent atrial fibrillation (more than 7 days, or less than 7 days needing pharmacologic or electric cardioversion) Exclusion Criteria: Hypo or hyperthyroidism Persistent atrial fibrillation lasting more than 1 year or non-defined duration Hypertrophic myocardiopathy 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 Contraindication to anticoagulation 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 Any cause that contraindicate ablation procedure or antiarrhythmic drug

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| Experimental: Atrial Fibrillation Ablation<br> | Procedure: Atrial fibrillation ablation<br>* Atrial fibrillation ablation with radiofrequency, guided by 3D navigation map. Either 4mm or cooled tip-catheters will be used. It will include, at least, pulmonary veins isolation; all other radiofrequency lines, including roof and mitral isthmus line, and complex fractioned electrograms ablation will be performed according to each Hospital protocol. Radiofrequency lines block will be tested.<br>|
| Active Comparator: Drug therapy<br> | Drug: Antiarrhythmic drug<br>* Usual drug therapy for atrial fibrillation. In patients with structural heart disease, amiodarone is recommended, while flecainide plus diltiazem or beta-blockers are encouraged in patients without structural heart diseases.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from atrial arrhythmias, lasting more than 24 hours or requiring cardioversion. |  | 1-year follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from atrial arrhythmias (lasting more than 30 seconds) without antiarrhythmic drugs. |  | 1-year follow-up | 
| Decrease in frequency and duration of atrial fibrillation or atrial flutter recurrences. |  | 1-year follow-up | 
| Decrease in atrial fibrillation/atrial flutter related hospital admissions |  | 1-year follow-up | 
| Improve in quality of life measured with standard questionary for Atrial Fibrillation: AF-QoL. |  | 1-year follow-up | 
| Change in need of cardioversions |  | From 3rd to 12th months | 
| Need of atrio-ventricular node ablation |  | 1-year follow-up | 
| Need of crossover to the other arm of the study (only when primary end point has been reached) |  | 1-year follow-up | 
| Need of a new intervention or ablation during blanking period |  | Until 3rd month | 
| Detection of asymptomatic episodes by Reveal XT |  | 1-year follow-up | 
| Presence of any complications in the acute phase or during follow-up |  | 1-year follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Catheter Ablation, Radiofrequency, Atrial fibrillation, Antiarrhythmic Drugs