Benefit of CFAE Ablation

Study Overview
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Brief Summary
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The optimal strategy for catheter ablation of persistent atrial fibrillation is not clearly defined. This study investigates if Complex Fractionated Atrial Electrogram (CFAE) ablation in addition to pulmonary vein isolation and linear ablations improves single procedural success rate over a 12 month follow up period.

Official Title
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A Study to Investigate the Benefit Of Complex Fractionated Atrial Electrogram (CFAE) Ablation in Addition to Circumferential Pulmonary Vein and Linear Ablations in the Treatment of Persistent Atrial Fibrillation. (BOCA)

Conditions
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Persistent Atrial Fibrillation

Intervention / Treatment
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* Procedure: Radiofrequency catheter Ablation
* Procedure: Radiofrequency catheter ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: persistent atrial fibrillation Exclusion Criteria: previous catheter or surgical ablation for atrial fibrillation pregnancy

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PVI + Linear ablation<br>Arm A: patients have PVI and roof and mitral isthmus lines | Procedure: Radiofrequency catheter Ablation<br>* In this arm, catheter ablation would be performed in the left atrium and would include pulmonary vein isolation and linear ablations (roof and mitral isthmus lines)<br>|
| Active Comparator: PVI + linear ablation + CFAE<br>Arm B: patients have PVI + roof and mitral isthmus lines and CFAE ablation | Procedure: Radiofrequency catheter ablation<br>* In this arm, catheter ablation would be performed in the left atrium, including pulmonary vein isolation, linear ablations (roof and mitral isthmus lines) and Complex Fractionated Atrial Electrograms (CFAE) ablation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Single procedural success rate (free from AF off anti-arrhythmic drugs) |  | 12 MONTHS | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Multiple procedure success rate |  | 12 months after last ablation | 
| Complication rate |  | 30 days of procedure | 
| Percentage of AF termination | This information will be recorded immediately after the procedure. | Time 0 | 
| recurrence of atrial fibrillation or organised atrial tachycardia |  | 12 months after the last procedure | 
| Ablation time | This information will be recorded immediately after the procedure. | Time 0 | 
| Procedure time | This information will be recorded immediately after the procedure | Time 0 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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catheter ablation, atrial fibrillation, pulmonary vein isolation, linear ablation, CFAE ablation