Therapy of Atrial Flutter by Afib Ablation (TripleA)
Primary Purpose
Atrial Fibrillation, Atrial Flutter
Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Antiarrhythmic drug
Cavo-tricuspid-isthmus-ablation
Pulmonary vein isolation
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring pulmonary vein isolation, isthmus ablation, recurrence
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
Sites / Locations
- Universitiy Medical Centre RostockRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Cavo-tricuspid-isthmus-ablation
Pulmonary vein isolation
Antiarrhythmic drug
Arm Description
Ablation of atrial flutter
pulmonary vein isolation
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
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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)
Full Information
NCT ID
NCT02051621
First Posted
December 3, 2013
Last Updated
January 30, 2014
Sponsor
University of Rostock
Collaborators
Biosense Webster, Inc., Medtronic
1. Study Identification
Unique Protocol Identification Number
NCT02051621
Brief Title
Therapy of Atrial Flutter by Afib Ablation
Acronym
TripleA
Official Title
Isolated Atrial Fibrillation Ablation in Patients With Isolated Atrial Flutter
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Unknown status
Study Start Date
August 2010 (undefined)
Primary Completion Date
August 2015 (Anticipated)
Study Completion Date
August 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rostock
Collaborators
Biosense Webster, Inc., Medtronic
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Atrial Flutter
Keywords
pulmonary vein isolation, isthmus ablation, recurrence
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cavo-tricuspid-isthmus-ablation
Arm Type
Active Comparator
Arm Description
Ablation of atrial flutter
Arm Title
Pulmonary vein isolation
Arm Type
Active Comparator
Arm Description
pulmonary vein isolation
Arm Title
Antiarrhythmic drug
Arm Type
Active Comparator
Arm 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
Intervention Type
Drug
Intervention Name(s)
Antiarrhythmic drug
Other Intervention Name(s)
medical treatment of atrial flutter
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Cavo-tricuspid-isthmus-ablation
Other Intervention Name(s)
Ablation of atrial flutter
Intervention Description
irrigated radiofrequency (RF)-ablation of the cavo-tricuspid-isthmus catheter used: Thermocool R (F-type), Biosense Webster, Diamond Bar, CA, USA
Intervention Type
Procedure
Intervention Name(s)
Pulmonary vein isolation
Intervention Description
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
Primary Outcome Measure Information:
Title
Number or patients with a recurrence of any atrial arrhythmia
Description
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
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Number of patients with atrial flutter recurrence
Description
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)
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ralph Schneider, MD
Email
ralph.schneider@med.uni-rostock.de
First Name & Middle Initial & Last Name or Official Title & Degree
Dietmar Baensch, PhD, MD
Email
diemar.baensch@med.uni-rostock.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dietmar Baensch, PhD, MD
Organizational Affiliation
University Medical Centre Rostock
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitiy Medical Centre Rostock
City
Rostock
ZIP/Postal Code
18057
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dietmar Baensch, PhD, MD
Email
dietmar.baensch@med.uni-rostock.de
First Name & Middle Initial & Last Name & Degree
Ralph Schneider, MD
First Name & Middle Initial & Last Name & Degree
Joerg Lauschke, MD
First Name & Middle Initial & Last Name & Degree
Wolfgang Voss, MD
First Name & Middle Initial & Last Name & Degree
Cindy Schneider, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
25638698
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.
Results Reference
derived
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Therapy of Atrial Flutter by Afib Ablation
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