Therapy of Atrial Flutter by Afib Ablation

Study Overview
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Brief Summary
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Ablation of the cavotricuspid isthmus (CTI) in the right atrium is currently the therapy of choice for the treatment of typical atrial flutter (3,4). It is a curative approach and has a high success rate (5). It has been recognized that patients with typical atrial flutter often complain of atrial fibrillation (1,2). Current clinical and experimental studies confirm the close relationship between atrial flutter (AFL) and atrial fibrillation (AF) and raise a question, if both arrhythmias are different forms of a common electrical phenomenon with atrial fibrillation being the underlying clinical problem (6).

Detailed Description
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Current clinical and experimental studies confirm the close relationship between atrial flutter (AFlut) and atrial fibrillation (Afib). After initiation of Afib this may organize under special intrinsic conditions or due to antiarrhythmic medication to AFlut so Afib may be supposed the underlying arrhythmia. Therefore after successful ablation of AFlut this reentrant circuit is not longer possible and Afib persists. After new occurrence of Afib a long diagnostic and therapeutic marathon begins with AF ablation at the end of all therapeutic efforts. This double burden for the patient and the health system can probably be avoided by directly and effectively treating the underlying arrhythmia AF.

Official Title
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Isolated Atrial Fibrillation Ablation in Patients With Isolated Atrial Flutter

Conditions
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Atrial Fibrillation, Atrial Flutter

Intervention / Treatment
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* Drug: Antiarrhythmic drug
* Procedure: Cavo-tricuspid-isthmus-ablation
* Procedure: Pulmonary vein isolation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with- in 12-Channel-ECG documented atrial tachycardia suggestive of typical isthmus dependent atrial flutter > 21 years Exclusion Criteria: - AFL as secondary to an accessory pathway Antiarrhythmic treatment for AF AF Previous AF ablation Dilatation of left atrium > 6 cm Cardiac surgery less < 3 weeks Congenital heart disease Cardiac ischemia or coronary artery disease that needs intervention Life expectancy less than 2 years

Ages Eligible for Study
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Minimum Age: 21 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: Cavo-tricuspid-isthmus-ablation<br>Ablation of atrial flutter | Procedure: Cavo-tricuspid-isthmus-ablation<br>* irrigated radiofrequency (RF)-ablation of the cavo-tricuspid-isthmus catheter used: Thermocool R (F-type), Biosense Webster, Diamond Bar, CA, USA<br>* Other names: Ablation of atrial flutter;|
| Active Comparator: Pulmonary vein isolation<br>pulmonary vein isolation | Procedure: Pulmonary vein isolation<br>* pulmonary vein angiography followed by antral pulmonary vein isolation using 3D-electroanatomical Mapping mapping system: Carto 3 (Biosense Webster, Diamond Bar, CA, USA) catheter used for irrigated RF-ablation: Navistar Thermocool R (D, E or F-type according to atrial dimensions), Biosense Webster, Diamond Bar, CA, USA<br>|
| Active Comparator: Antiarrhythmic drug<br>Medical treatment of atrial flutter with either class I antiarrhythmics (flecainide (Tambocor ®) 100 mg twice daily or propafenone (Rytmonorm ®) up to 150 mg 3 times daily) or amiodarone (Cordarex®) 200 mg daily cardioversion as needed | Drug: Antiarrhythmic drug<br>* medical treatment of atrial flutter with either flecainide (Tambocor ®) 100 mg twice daily, propafenone (Rytmonorm ®) up to 150 mg 3 times daily) or amiodarone (Cordarex®) 200 mg daily electrical cardioversion as needed<br>* Other names: medical treatment of atrial flutter;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number or patients with a recurrence of any atrial arrhythmia | Number (percentage) of patients with any atrial arrhythmia lasting longer than 30 s after ablation assessed by implantable loop recorder or 7-day-holter-ECG: AFL after AF ablation compared to the AFL ablation group and AF in both ablation groups | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with atrial flutter recurrence | Number (percentage) of patients with any AFL episode after ablation or under medical therapy assessed by implantable loop recorder or 7-day-holter-ECG, compared between all 3 interventions (medical treatment vs. AFL Ablation vs. AF ablation) | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pulmonary vein isolation, isthmus ablation, recurrence