Linear Ablation Versus Focal Ablation of Complex Fractionated Atrial Electrograms in Persistent Atrial Fibrillation

Study Overview
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Brief Summary
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The end point of catheter ablation at complex fractionated atrial electrograms (CFAE) was not established yet. Furthermore, incomplete CFAE ablation may have a potential to develop atrial tachyarrhythmias (AT). The investigators hypothesized that linear ablation extending the clusters of CFAE would be a better strategy than focal ablation at the individual CFAE sites.

Official Title
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Comparison of Linear Ablation Versus Focal Ablation of Complex Fractionated Atrial Electrograms After Pulmonary Vein Isolation in Patients With Persistent Atrial Fibrillation: A Prospective & Randomized Controlled Study

Conditions
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Persistent Atrial Fibrillation

Intervention / Treatment
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* Procedure: radiofrequency catheter ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients age 18 or greater persistent atrial fibrillation candidates for AF ablation based on AF that is symptomatic and refractory to at least one antiarrhythmic medication at least one episode of AF must have been documented by ECG or Holter within 12 months of randomization in the trial continuous anticoagulation with warfarin (INR 2-3) for >4 weeks prior to the ablation patients must be able and willing to provide written informed consent to participate in the clinical trial Exclusion Criteria: paroxysmal or permanent atrial fibrillation patients with AF felt to be secondary to an obvious reversible cause inadequate anticoagulation as defined in the inclusion criteria left atrial thrombus on TEE prior to procedure contraindications to systemic anticoagulation with heparin or coumadin previously undergone atrial fibrillation ablation patients who are or may potentially be pregnant

Ages Eligible for Study
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Minimum Age: 18 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: Focal ablation<br>PV isolation + CFAE-targeted focal ablation | Procedure: radiofrequency catheter ablation<br>* radiofrequency catheter ablation, NavX system<br>|
| Active Comparator: Linear ablation<br>PV isolation + CFAE-guided linear ablation | Procedure: radiofrequency catheter ablation<br>* radiofrequency catheter ablation, NavX system<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| freedom from AF/AT more than 3 months after first ablation |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| freedom from AF/AT within 3 months following first ablation |  | 3 months | 
| acute intra-procedure termination of AF |  | 12 months | 
| organization of AF/conversion to AT during the ablation |  | 12 months | 
| procedure time |  | 12 months | 
| ablation time |  | 12 months | 
| procedure-related complication |  | 12 months |