Stepwise Approach Versus Linear Ablation in Patients With Recurrence of Persistent Atrial Fibrillation

Study Overview
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Brief Summary
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Catheter ablation of persistent atrial fibrillation (AF) remains a challenging procedure. Even in experienced centres, repeat interventions are necessary in up to 70 of patients to achieve sinus rhythm at a long-term follow-up. While there is a consensus to perform pulmonary vein isolation (PVI) as a cornerstone for the ablation of paroxysmal and persistent AF ablation, different additional ablation strategies are used to achieve a modification of the substrate that perpetuates the arrhythmia: linear lesions (anterior and roof lines) or ablation of complex fractionated atrial electrograms (CFAE). In the stepwise approach PVI, CFAE ablation and/or LL are combined according to the presenting arrhythmia during procedure. The aim of the study is to determine whether there is a difference in terms of freedom from arrhythmia between a stepwise approach and a linear ablation for repeat procedure in patient with recurrence of persistent atrial fibrillation.

Official Title
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Stepwise Approach Versus Linear Ablation for Repeat Procedure in Patients With Recurrence of Persistent Atrial Fibrillation

Conditions
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Atrial Fibrillation, Recurrence

Intervention / Treatment
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* Procedure: Ablation with stepwise approach
* Procedure: Linear ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with recurrence of symptomatic persistent atrial fibrillation after at least one ablation procedure, with the last ablation procedure at least 3 months ago. at least one unsuccessful attempt of antiarrhythmic drug oral anticoagulation for at least 4 weeks prior to ablation Exclusion Criteria: LA thrombus

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Stepwise approach<br>Stepwise approach for repeat AF ablation | Procedure: Ablation with stepwise approach<br>* Stepwise approach for repeat AF ablation<br>Procedure: Linear ablation<br>* Linear ablation for AF ablation<br>|
| Active Comparator: Linear ablation<br>Linear ablation for repeat procedure in patients with recurrent atrial fibrillation | Procedure: Ablation with stepwise approach<br>* Stepwise approach for repeat AF ablation<br>Procedure: Linear ablation<br>* Linear ablation for AF ablation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from atrial arrhythmia | Documented freedom from atrial arrhythmia (AF or AT) during follow-up. |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural and safety data | Duration of left atrial procedure, ablation time, fluoroscopy time. Complications Type of recurrent arrhythmia Number of reablation |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial fibrillation, recurrence, repeat procedure, linear ablation, stepwise approach