Antero-Posterior Versus Antero-Lateral Electrode Position for Electrical Cardioversion of Typical Atrial Flutter - Full Text View

Sponsored by:	Universitätsklinikum Hamburg-Eppendorf
Information provided by:	Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier:	NCT00860314

Purpose

The aim of this study is to identify the one electrode position out of two most commonly used for external electrical cardioversion of typical atrial flutter, which needs less delivered energy and less needed number of shocks for successful cardioversion.

Condition	Intervention
Atrial Flutter	Procedure: external electrical cardioversion (with antero-posterior electrode position) Procedure: external electrical cardioversion (with antero-lateral electrode position)

Genetics Home Reference related topics: Brugada syndrome short QT syndrome

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Prospective, Randomized Single-Center Study for Efficacy of Antero-Posterior and Antero-Lateral Electrode Position for External Electrical Cardioversion of Typical Atrial Flutter

Further study details as provided by Universitätsklinikum Hamburg-Eppendorf:

Primary Outcome Measures:

Number of Successfully Cardioverted Participants for Each Electrode Position [ Time Frame: 30 seconds after cardioversion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Mean Number of Cardioversion Shocks [ Time Frame: 30 seconds after cardioversion ] [ Designated as safety issue: No ]
Mean Energy Requirement for Successful Cardioversion [ Time Frame: 30 seconds after cardioversion ] [ Designated as safety issue: No ]
Number of Participants Succesfully Cardioverted With First Shock in Each Electrode Position [ Time Frame: 30 seconds after cardioversion ] [ Designated as safety issue: No ]

Enrollment:	96
Study Start Date:	January 2005
Study Completion Date:	December 2005
Primary Completion Date:	December 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Cardioversion with antero-posterior electrode position	Procedure: external electrical cardioversion (with antero-posterior electrode position) external biphasic electrical cardioversion with step-up-protocol of 50-75-100-150-200 Joules if necessary with antero-posterior electrode position until restoration of normal sinus rhythm
2: Active Comparator Cardioversion with antero-lateral electrode position	Procedure: external electrical cardioversion (with antero-lateral electrode position) external biphasic electrical cardioversion with step-up protocol of 50-75-100-150-200 Joules if necessary with antero-lateral electrode position until restoration of normal sinus rhythm

Detailed Description:

Typical atrial flutter is the second-most prevalent atrial tachyarrhythmia. No guidelines for treatment exist and few studies investigate treatment of atrial flutter. Mostly, guidelines for atrial fibrillation are followed for treatment of atrial flutter. Atrial flutter has a different pathomechanism as atrial fibrillation, therefore special guidelines for treatment are needed. Among drug treatment and ablation procedures, external electrical cardioversion is commonly used, especially for treatment of acute symptomatic patients. This study may help to further define safe and successful procedures for electrical cardioversion of atrial flutter.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

clinical diagnosis of typical atrial flutter
signed written informed consent
eligibility for sedation and external electrical cardioversion

Exclusion Criteria:

clinical diagnosis of arrhythmia other than typical atrial flutter
implanted ICD or pacemaker
proof of atrial thrombi

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00860314

Locations

Germany
University Hospital Hamburg-Eppendorf, Heart Center
Hamburg, Germany, 20246

Sponsors and Collaborators

Universitätsklinikum Hamburg-Eppendorf

Investigators

Study Chair:

Stephan Willems, Prof. Dr.

Oberarzt

More Information

Additional Information:

Homepage of University Hospital Hamburg-Eppendorf This link exits the ClinicalTrials.gov site

Publications:

Kerber RE, Kouba C, Martins J, Kelly K, Low R, Hoyt R, Ferguson D, Bailey L, Bennett P, Charbonnier F. Advance prediction of transthoracic impedance in human defibrillation and cardioversion: importance of impedance in determining the success of low-energy shocks. Circulation. 1984 Aug;70(2):303-8.

Kirchhof P, Eckardt L, Loh P, Weber K, Fischer RJ, Seidl KH, Böcker D, Breithardt G, Haverkamp W, Borggrefe M. Anterior-posterior versus anterior-lateral electrode positions for external cardioversion of atrial fibrillation: a randomised trial. Lancet. 2002 Oct 26;360(9342):1275-9.

Kirchhof P, Borggrefe M, Breithardt G. Effect of electrode position on the outcome of cardioversion. Card Electrophysiol Rev. 2003 Sep;7(3):292-6. Review.

Kerber RE, Jensen SR, Grayzel J, Kennedy J, Hoyt R. Elective cardioversion: influence of paddle-electrode location and size on success rates and energy requirements. N Engl J Med. 1981 Sep 17;305(12):658-62.

Botto GL, Politi A, Bonini W, Broffoni T, Bonatti R. External cardioversion of atrial fibrillation: role of paddle position on technical efficacy and energy requirements. Heart. 1999 Dec;82(6):726-30.

Yoon RS, DeMonte TP, Hasanov KF, Jorgenson DB, Joy ML. Measurement of thoracic current flow in pigs for the study of defibrillation and cardioversion. IEEE Trans Biomed Eng. 2003 Oct;50(10):1167-73.

Van Gelder IC, Tuinenburg AE, Schoonderwoerd BS, Tieleman RG, Crijns HJ. Pharmacologic versus direct-current electrical cardioversion of atrial flutter and fibrillation. Am J Cardiol. 1999 Nov 4;84(9A):147R-151R. Review.

Kerber RE. Transthoracic cardioversion of atrial fibrillation and flutter: standard techniques and new advances. Am J Cardiol. 1996 Oct 17;78(8A):22-6. Review.

Camacho MA, Lehr JL, Eisenberg SR. A three-dimensional finite element model of human transthoracic defibrillation: paddle placement and size. IEEE Trans Biomed Eng. 1995 Jun;42(6):572-8.

Kirchhof P, Mönnig G, Wasmer K, Heinecke A, Breithardt G, Eckardt L, Böcker D. A trial of self-adhesive patch electrodes and hand-held paddle electrodes for external cardioversion of atrial fibrillation (MOBIPAPA). Eur Heart J. 2005 Jul;26(13):1292-7. Epub 2005 Feb 25.

Responsible Party:	Ltd. Oberarzt des Universitären Herzzentrums Hamburg ( Prof. Dr. med. Stephan Willems )
Study ID Numbers:	UKE-2383
Study First Received:	November 10, 2008
Results First Received:	November 10, 2008
Last Updated:	March 11, 2009
ClinicalTrials.gov Identifier:	NCT00860314 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Universitätsklinikum Hamburg-Eppendorf:

external electrical cardioversion
typical atrial flutter
electrode position
antero-lateral

antero-posterior
biphasic cardioversion
step-up protocol

Study placed in the following topic categories:

Heart Diseases
Atrial Flutter
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Atrial Flutter
Arrhythmias, Cardiac

ClinicalTrials.gov processed this record on May 07, 2009