Line Versus Spot Ablation in Persistent Atrial Fibrillation

Study Overview
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Brief Summary
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In this randomized study dealing with the ablative treatment of persistent atrial fibrillation, two ablation strategies are compared: a more anatomically guided linear ablation scheme versus an electrophysiological guided focal ablation strategy aiming at the electrical isolating of the pulmonary veins and ablating areas of fragmented intracardiac electrograms thought to maintain atrial fibrillation.

Detailed Description
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This randomized study deals with two different ablative treatment strategies for persistent atrial fibrillation: a more anatomically guided linear ablation scheme with encircling of the ipsilateral pulmonary veins (PV), a left atrial roof line and an anterior line bridging the anterior mitral anulus to the ostium of the left superior PV versus an electrophysiological guided focal ablation strategy aiming at isolating, electrically, the PV and ablating areas of fragmented intracardiac electrograms thought to maintain atrial fibrillation. Both ablation approaches contain isolation of the most common source of triggering foci, i.e., the pulmonary veins and additional modification of the substrate maintaining atrial fibrillation. The study endpoint is a combined efficacy/safety analysis. Extensive follow-up with three-monthly 7 days holter ECG is provided.

Official Title
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Linear Anatomically Versus Focal Electrophysiologically Guided Substrate Ablation in Patients With Persistent Atrial Fibrillation

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Procedure: linear anatomically oriented ablations
* Procedure: focal electrophysiological oriented ablations


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age between 18 and 80 years symptomatic persistent (> 7 days lasting) atrial fibrillation at least one unsuccessful cardioversion or atrial fibrillation relapse in the first 3 months after cardioversion despite antiarrhythmic drug therapy oral anticoagulation (> 4 weeks prior to ablation) Exclusion Criteria: moderate to severe valvular heart disease congenital heart disease LV-EF < 35% reversible cause for atrial fibrillation (e.g., hyperthyreosis) prior left atrial ablation or Maze operation left atrial 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 |
| --- | --- |
| Experimental: 1<br>linear lesions to ablate persistent atrial fibrillation | Procedure: linear anatomically oriented ablations<br>* linear lesions to ablate persistent atrial fibrillation<br>|
| Experimental: 2<br>focal electrophysiologically guided ablations to treat persistent atrial fibrillation | Procedure: focal electrophysiological oriented ablations<br>* focal electrophysiologically guided ablations to treat persistent atrial fibrillation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sinus rhythm in follow-up |  | Sinus rhythm in follow-up |