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Therapy of Atrial Flutter by Afib Ablation

NCT ID: NCT02051621

Last Updated: 2014-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2017-08-31

Brief Summary

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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

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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.

Conditions

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Atrial Fibrillation Atrial Flutter

Keywords

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pulmonary vein isolation isthmus ablation recurrence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cavo-tricuspid-isthmus-ablation

Ablation of atrial flutter

Group Type ACTIVE_COMPARATOR

Cavo-tricuspid-isthmus-ablation

Intervention Type PROCEDURE

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 isolation

Group Type ACTIVE_COMPARATOR

Pulmonary vein isolation

Intervention Type 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

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

Group Type ACTIVE_COMPARATOR

Antiarrhythmic drug

Intervention Type 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

Interventions

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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

Intervention Type DRUG

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

Intervention Type 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

Intervention Type PROCEDURE

Other Intervention Names

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medical treatment of atrial flutter Ablation of atrial flutter

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biosense Webster, Inc.

INDUSTRY

Sponsor Role collaborator

Medtronic

INDUSTRY

Sponsor Role collaborator

University of Rostock

OTHER

Sponsor Role lead

Responsible Party

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Dietmar Baensch

Professor Dr. med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dietmar Baensch, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

University Medical Centre Rostock

Locations

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Universitiy Medical Centre Rostock

Rostock, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Ralph Schneider, MD

Role: CONTACT

Email: [email protected]

Dietmar Baensch, PhD, MD

Role: CONTACT

Email: [email protected]

Facility Contacts

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Dietmar Baensch, PhD, MD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 25638698 (View on PubMed)

Other Identifiers

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A201070

Identifier Type: -

Identifier Source: org_study_id