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

NCT00860314 | Terminated Results

• 1 other identifier: UKE-2383
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atrial Flutter

Keywords

external electrical cardioversion; typical atrial flutter; electrode position; antero-lateral; antero-posterior; biphasic cardioversion; step-up protocol

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Mean Number of Cardioversion Shocks

  30 seconds after cardioversion

• Mean Energy Requirement for Successful Cardioversion

  30 seconds after cardioversion

• Number of Participants Succesfully Cardioverted With First Shock in Each Electrode Position

  30 seconds after cardioversion

Study Arms (2)

AP Position

ACTIVE COMPARATOR

Cardioversion with antero-posterior electrode position

Procedure: external electrical cardioversion (with antero-posterior electrode position)

AL Position

ACTIVE COMPARATOR

Cardioversion with antero-lateral electrode position

Procedure: external electrical cardioversion (with antero-lateral electrode position)

Interventions

external electrical cardioversion (with antero-posterior electrode position) PROCEDURE

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

Also known as: biphasic cardioversion, countershock treatment

AP Position

external electrical cardioversion (with antero-lateral electrode position) PROCEDURE

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

Also known as: biphasic cardioversion, countershock treatment

AL Position

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (1)

University Hospital Hamburg-Eppendorf, Heart Center

Hamburg, 20246, Germany

Location

Related Publications (10)

• 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. doi: 10.1161/01.cir.70.2.303.

  PMID: 6733884 BACKGROUND

• Kirchhof P, Eckardt L, Loh P, Weber K, Fischer RJ, Seidl KH, Bocker 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. doi: 10.1016/s0140-6736(02)11315-8.

  PMID: 12414201 BACKGROUND

• Kirchhof P, Borggrefe M, Breithardt G. Effect of electrode position on the outcome of cardioversion. Card Electrophysiol Rev. 2003 Sep;7(3):292-6. doi: 10.1023/B:CEPR.0000012399.96959.ab.

  PMID: 14739731 BACKGROUND

• 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. doi: 10.1056/NEJM198109173051202.

  PMID: 7266602 BACKGROUND

• 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. doi: 10.1136/hrt.82.6.726.

  PMID: 10573502 BACKGROUND

• 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. doi: 10.1109/TBME.2003.816082.

  PMID: 14560770 BACKGROUND

• 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. doi: 10.1016/s0002-9149(99)00715-8.

  PMID: 10568674 BACKGROUND

• Kerber RE. Transthoracic cardioversion of atrial fibrillation and flutter: standard techniques and new advances. Am J Cardiol. 1996 Oct 17;78(8A):22-6. doi: 10.1016/s0002-9149(96)00562-0.

  PMID: 8903272 BACKGROUND

• 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. doi: 10.1109/10.387196.

  PMID: 7790013 BACKGROUND

• Kirchhof P, Monnig G, Wasmer K, Heinecke A, Breithardt G, Eckardt L, Bocker 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. doi: 10.1093/eurheartj/ehi160. Epub 2005 Feb 25.

  PMID: 15734772 BACKGROUND

Related Links

• Homepage of University Hospital Hamburg-Eppendorf

MeSH Terms

Conditions

Atrial Flutter

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Tim Risius, MD
• Organization: University Hospital Hamburg-Eppendorf, Heart Center

risius@uke.uni-hamburg.de

+49-40-42803

Study Officials

• Stephan Willems, Prof. Dr.

  Oberarzt

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ltd. Oberarzt des Universitären Herzzentrums Hamburg

Study Record Dates

• First Submitted: November 10, 2008
• First Posted: March 12, 2009
• Study Start: January 1, 2005
• Primary Completion: December 1, 2005
• Study Completion: December 1, 2005
• Last Updated: August 27, 2015
• Results First Posted: March 12, 2009

Record last verified: 2015-08

Locations

DE (1)