Therapy of Atrial Flutter by Afib Ablation (TripleA)

January 30, 2014 updated by: Dietmar Baensch, University of Rostock

Isolated Atrial Fibrillation Ablation in Patients With Isolated Atrial Flutter

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
      • Rostock, Germany, 18057
        • Recruiting
        • Universitiy Medical Centre Rostock
        • Contact:
        • Sub-Investigator:
          • Ralph Schneider, MD
        • Sub-Investigator:
          • Joerg Lauschke, MD
        • Sub-Investigator:
          • Wolfgang Voss, MD
        • Sub-Investigator:
          • Cindy Schneider, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Cavo-tricuspid-isthmus-ablation
Ablation of atrial flutter
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
Other Names:
  • Ablation of atrial flutter
Active Comparator: Pulmonary vein isolation
pulmonary vein isolation
Procedure: 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
Active Comparator: 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
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
Other Names:
  • medical treatment of atrial flutter

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number or patients with a recurrence of any atrial arrhythmia
Time Frame: 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
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with atrial flutter recurrence
Time Frame: 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)
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rostock

Collaborators

Medtronic
Biosense Webster, Inc.

Investigators

  • Principal Investigator: Dietmar Baensch, PhD, MD, University Medical Centre Rostock

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Anticipated)

August 1, 2015

Study Completion (Anticipated)

August 1, 2017

Study Registration Dates

First Submitted

December 3, 2013

First Submitted That Met QC Criteria

January 30, 2014

First Posted (Estimate)

January 31, 2014

Study Record Updates

Last Update Posted (Estimate)

January 31, 2014

Last Update Submitted That Met QC Criteria

January 30, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A201070

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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