Therapy of Atrial Flutter by Afib Ablation

Not Applicable

• Conditions: Atrial Fibrillation; Atrial Flutter
• Interventions: Procedure: Cavo-tricuspid-isthmus-ablation; Procedure: Pulmonary vein isolation; Drug: Antiarrhythmic drug

• Registration Number: NCT02051621
• Lead Sponsor: University of Rostock

Brief Summary

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

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.

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2013-12-03
• Status Verified: 2014-01
• Study First Submitted QC: 2014-01-30
• Last Update Submitted: 2014-01-30
• Study First Posted: 2014-01-31
• Last Update Posted: 2014-01-31
• Primary Completion: 2015-08
• Study Completion: 2017-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cavo-tricuspid-isthmus-ablation	Cavo-tricuspid-isthmus-ablation	Ablation of atrial flutter
Pulmonary vein isolation	Pulmonary vein isolation	pulmonary vein isolation
Antiarrhythmic drug	Antiarrhythmic drug	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

Primary Outcome Measures

Name	Time	Method
Number or patients with a recurrence of any atrial arrhythmia	2 years	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

Secondary Outcome Measures

Name	Time	Method
Number of patients with atrial flutter recurrence	2 years	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)

Trial Locations

Locations (1)

Universitiy Medical Centre Rostock; 🇩🇪 Rostock, Germany