Therapy of Atrial Flutter by Afib Ablation (TripleA)

University of Rostock

Status: Unknown

Conditions: Atrial Flutter; Atrial Fibrillation

Treatments: Procedure: Pulmonary vein isolation; Drug: Antiarrhythmic drug; Procedure: Cavo-tricuspid-isthmus-ablation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02051621

A201070

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 3 patient groups

Cavo-tricuspid-isthmus-ablation

Active Comparator group

Description:

Ablation of atrial flutter

Treatment:

Procedure: Cavo-tricuspid-isthmus-ablation

Pulmonary vein isolation

Active Comparator group

Description:

pulmonary vein isolation

Treatment:

Procedure: Pulmonary vein isolation

Antiarrhythmic drug

Active Comparator group

Description:

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

Treatment:

Drug: Antiarrhythmic drug