Therapy of Atrial Flutter by Afib Ablation

Atrial Fibrillation Clinical Trial

— TripleA  

Official title:

Isolated Atrial Fibrillation Ablation in Patients With Isolated Atrial Flutter

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02051621
• Other study ID #: A201070
• Status: Recruiting
• Phase: N/A
• First received: December 3, 2013
• Last updated: January 30, 2014
• Start date: August 2010
• Est. completion date: August 2017

Study information

• Verified date: January 2014
• Source: University of Rostock
• Contact: Ralph Schneider, MD
• Email: ralph.schneider[@]med.uni-rostock.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 2017
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Flutter

Intervention

Drug:
• Antiarrhythmic drug
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

Procedure:
• Cavo-tricuspid-isthmus-ablation
irrigated radiofrequency (RF)-ablation of the cavo-tricuspid-isthmus catheter used: Thermocool R (F-type), Biosense Webster, Diamond Bar, CA, USA
• Pulmonary vein isolation
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

Locations

Country	Name	City	State
Germany	Universitiy Medical Centre Rostock	Rostock

Sponsors (3)

Lead Sponsor	Collaborator
University of Rostock	Biosense Webster, Inc., Medtronic

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No