Therapy of Atrial Flutter by Afib Ablation

NCT02051621 | Unknown

• 1 other identifier: A201070
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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).

Conditions

Atrial Fibrillation; Atrial Flutter

Keywords

pulmonary vein isolation; isthmus ablation; recurrence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of patients with atrial flutter recurrence

  2 years

Study Arms (3)

Cavo-tricuspid-isthmus-ablation

ACTIVE COMPARATOR

Ablation of atrial flutter

Procedure: Cavo-tricuspid-isthmus-ablation

Pulmonary vein isolation

ACTIVE COMPARATOR

pulmonary vein isolation

Procedure: Pulmonary vein isolation

Antiarrhythmic drug

ACTIVE COMPARATOR

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

Interventions

Antiarrhythmic drug 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

Also known as: medical treatment of atrial flutter

Antiarrhythmic drug

Cavo-tricuspid-isthmus-ablation PROCEDURE

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

Also known as: Ablation of atrial flutter

Cavo-tricuspid-isthmus-ablation

Pulmonary vein isolation PROCEDURE

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

Pulmonary vein isolation

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with- in 12-Channel-ECG documented atrial tachycardia suggestive of typical isthmus dependent atrial flutter
• \> 21 years

You may not qualify if:

• \- AFL as secondary to an accessory pathway
• Antiarrhythmic treatment for 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

Sponsors & Collaborators

• University of Rostock: lead
• Biosense Webster, Inc.: collaborator
• Medtronic: collaborator

Study Sites (1)

Universitiy Medical Centre Rostock

Rostock, 18057, Germany

RECRUITING

Related Publications (1)

• Schneider R, Lauschke J, Tischer T, Schneider C, Voss W, Moehlenkamp F, Glass A, Diedrich D, Bansch D. Pulmonary vein triggers play an important role in the initiation of atrial flutter: Initial results from the prospective randomized Atrial Fibrillation Ablation in Atrial Flutter (Triple A) trial. Heart Rhythm. 2015 May;12(5):865-71. doi: 10.1016/j.hrthm.2015.01.040. Epub 2015 Jan 28.

  PMID: 25638698 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation; Atrial Flutter; Recurrence

Interventions

Anti-Arrhythmia Agents

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Intervention Hierarchy (Ancestors)

Cardiovascular Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Dietmar Baensch, PhD, MD

  University Medical Centre Rostock

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ralph Schneider, MD

CONTACT

ralph.schneider@med.uni-rostock.de

Dietmar Baensch, PhD, MD

CONTACT

diemar.baensch@med.uni-rostock.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Dr. med.

Study Record Dates

• First Submitted: December 3, 2013
• First Posted: January 31, 2014
• Study Start: August 1, 2010
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2017
• Last Updated: January 31, 2014

Record last verified: 2014-01

Locations

DE (1)