Antero-posterior Versus Antero-lateral Electrode Position for Electrical Cardioversion of Typical Atrial Flutter

Atrial Flutter Clinical Trial

— APOVERSAL  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00860314
• Other study ID #: UKE-2383
• Status: Terminated
• Phase: N/A
• First received: November 10, 2008
• Last updated: August 17, 2015
• Start date: January 2005
• Est. completion date: December 2005

Study information

• Verified date: August 2015
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 96
• Est. completion date: December 2005
• Est. primary completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Flutter

Intervention

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
• 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

Locations

Country	Name	City	State
Germany	University Hospital Hamburg-Eppendorf, Heart Center	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

References & Publications (10)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Successfully Cardioverted Participants for Each Electrode Position	After restoration of normal sinus rhythm for 30 seconds and longer by electrical countershock a cardioversion is counted as successful.	30 seconds after cardioversion	No
Secondary	Mean Number of Cardioversion Shocks		30 seconds after cardioversion	No
Secondary	Mean Energy Requirement for Successful Cardioversion	Overall energy in the mean (number of joules) necessary for successful cardioversion of all patients per group.	30 seconds after cardioversion	No
Secondary	Number of Participants Succesfully Cardioverted With First Shock in Each Electrode Position	Number of participants successfully cardioverted to normal sinus rhythm with one shock of 50 Joules.	30 seconds after cardioversion	No

External Links

•   Homepage of University Hospital Hamburg-Eppendorf