Ablating Atrial Tachycardias Occuring During Ablation of Complex Fractionated Electrograms in Persistent AF

Study Overview
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Brief Summary
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Catheter ablation has proven to be an effective treatment option in patients suffering from symptomatic persistent atrial fibrillation (AF). Catheter ablation consists of two major steps: (1) Isolation of pulmonary veins to abolish the trigger of atrial fibrillation and (2) modification of left atrial and eventually right atrial substrate by ablation of complex fractionated atrial electrograms (CFAE). CFAE are mainly found at the ostia of the pulmonary veins, around the left atrial appendage, at the mitral annulus and the septum. When ablating CFAE 40-65% of the patients show a regularization of AF to an atrial tachycardia (AT) that can be macro- or micro-reentrant (localized re-entry). Until now the significance of the AT is unclear. In the following study we examine the hypothesis that an ablation of AT occuring during CFAE ablation (group 1) significantly improves outcome defined as freedom of atrial arrhythmia (AF or AT) compared to patients that are cardioverted when AF has regularized to AT (group 2).

Official Title
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Ablating Atrial Tachycardias Occuring During Ablation of Complex Fractionated Electrograms in Persistent AF - ATTAC CFAE Trial

Conditions
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Atrial Fibrillation, Ablation, Atrial Flutter

Intervention / Treatment
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* Procedure: Ablation
* Procedure: Cardioversion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients (>=18 und < 80 years) with symptomatic persistent AF (AF episode enduring at least 7 days) but are successfully convertable in sinus rhythm (SR). At least one unsuccessful attempt of antiarrhythmic drug (betablocker or class I oder III). Oral anticoagulation with phenprocoumone or warfarine for at least 4 weeks prior to ablation with weekly documented INR > 2.. Withdrawal of antiarrhythmic drugs at least 3 half times prior to ablation except amiodarone. Atrial tachycardia occurring during ablation of CFAE (defined as CL > 200 msec und stable activation sequence). Exclusion Criteria: -

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: Ablation<br>Ablation of atrial tachycardia | Procedure: Ablation<br>* Ablation of atrial tachycardia<br>|
| Active Comparator: Cardioversion<br>Cardioversion of atrial tachycardia | Procedure: Cardioversion<br>* Cardioversion of atrial tachycardia<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural and safety data | Duration of left atrial procedure, time of ablation, time of radiation and radiation dose from randomization until the end of the procedure. In case of recurrence, characteristic of predominant tachyarrhythmia (AF or AT). Safety parameters (pericardial tamponade, thrombembolic complications). Number of re-ablations. |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial fibrillation, ablation, atrial flutter