Clinical trial NCT02051621: Therapy of Atrial Flutter by Afib Ablation
Official title: Isolated Atrial Fibrillation Ablation in Patients With Isolated Atrial Flutter
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atrial Fibrillation
Atrial Flutter
Keywords: pulmonary vein isolation
isthmus ablation
recurrence
Lead sponsor: University of Rostock
Sponsor class: OTHER
Collaborators: name: Biosense Webster, Inc.
name: Medtronic
First posted: 2014-01-31
Enrollment: 100
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number or patients with a recurrence of any atrial arrhythmia
timeFrame: 2 years
Secondary outcomes:
measure: Number of patients with atrial flutter recurrence
timeFrame: 2 years
Other outcomes:
Locations:
city: Rostock
country: Germany
facility: Universitiy Medical Centre Rostock
Study officials:
affiliation: University Medical Centre Rostock
name: Dietmar Baensch, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.