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

NCT ID: NCT00860314

Last Updated: 2015-08-27

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2005-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Atrial Flutter

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

AP Position

Cardioversion with antero-posterior electrode position

Group Type ACTIVE_COMPARATOR

external electrical cardioversion (with antero-posterior electrode position)

Intervention Type 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

AL Position

Cardioversion with antero-lateral electrode position

Group Type ACTIVE_COMPARATOR

external electrical cardioversion (with antero-lateral electrode position)

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type 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

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

biphasic cardioversion countershock treatment biphasic cardioversion countershock treatment

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Prof. Dr. Stephan Willems

Ltd. Oberarzt des Universitären Herzzentrums Hamburg

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Stephan Willems, Prof. Dr.

Role: STUDY_CHAIR

Oberarzt

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Hospital Hamburg-Eppendorf, Heart Center

Hamburg, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 6733884 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12414201 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14739731 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7266602 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10573502 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14560770 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10568674 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8903272 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7790013 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15734772 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

http://www.uke.de

Homepage of University Hospital Hamburg-Eppendorf

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

UKE-2383

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

N-of-1 in ATS and MEPPC
NCT06205550 NOT_YET_RECRUITING PHASE2