Benefit of Complex Fractionated Atrial Electrograms Elimination in Atrial Fibrillation Ablation

Study Overview
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Brief Summary
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The aim of this study is to evaluate whether performing complex fractionated atrial electrograms ablation improves outcomes in persistent or atrial fibrillation ablation.

Official Title
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Benefit of Complex Fractionated Atrial Electrograms Elimination in Atrial Fibrillation Ablation

Conditions
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Atrial Fibrillation, Catheter Ablation

Intervention / Treatment
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* Procedure: Additional Complex Fractionated Electrograms ablation
* Procedure: Standard atrial fibrillation ablation procedure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with persistent (more than 7 days, or less than 7 days needing pharmacologic or electric cardioversion) Presence of atrial fibrillation at the beginning of the procedure Exclusion Criteria: Hypo or hyperthyroidism Persistent long-lasting or non-defined duration atrial fibrillation 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ACVP plus roof line<br>Standard procedure for atrial fibrillation ablation, including pulmonary vein isolation plus roof line ablation. All ablation lines will be tested. | Procedure: Standard atrial fibrillation ablation procedure<br>* Standard procedure for persistent atrial fibrillation including circumferential pulmonary vein ablation and roof line, both being tested. No other lines or lesions will be performed.<br>* Other names: Roof line;|
| Active Comparator: Additional CFAEs ablation<br>Atrial fibrillation ablation with pulmonary vein ablation and roof line. In addition, complex fractionated atrial electrograms ablation will be performed, lasting at most 30 minutes. | Procedure: Additional Complex Fractionated Electrograms ablation<br>* Atrial fibrillation ablation with pulmonary vein ablation and roof line. In addition, complex fractionated atrial electrograms ablation will be performed, lasting at most 30 minutes.<br>* Other names: Complex atrial fractionated electrograms ablation;|

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 form 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 | 
| Freedom from atypical atria flutter |  | 1-year follow-up | 
| Increase in radioscopy time and radiofrequency application time |  | 1-year follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CFAE, Atrial fibrillation, Complex fractionated electrograms