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Atrial FlutterAPOVERSALNCT00860314

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

A study testing external electrical cardioversion (with antero-posterior electrode position) and external electrical cardioversion (with antero-lateral electrode position) in people with Atrial Flutter, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atrial Flutter
What is being tested?
external electrical cardioversion (with antero-posterior electrode position) and external electrical cardioversion (with antero-lateral electrode position)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
96 participants
Where
1 siteGermany
Study dates
Jan 2005to Dec 2005
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • University Hospital Hamburg-Eppendorf, Heart Center

    Hamburg, 20246

Other trials in Germany

About this 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

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.

Read the 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.

Conditions
Atrial Flutter
Being tested
external electrical cardioversion (with antero-posterior electrode position), external electrical cardioversion (with antero-lateral electrode position)
Keywords
external electrical cardioversion, typical atrial flutter, electrode position, antero-lateral, antero-posterior, biphasic cardioversion, step-up protocol
Medical subject headings
Atrial Flutter

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • external electrical cardioversion (with antero-posterior electrode position)Procedure or surgery

    Also called biphasic cardioversion, countershock treatment

    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)Procedure or surgery

    Also called biphasic cardioversion, countershock treatment

    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

Study groups in NCT00860314
Study groupRoleWhat they receive
AP PositionActive comparatorCardioversion with antero-posterior electrode position
Receives: Procedure: external electrical cardioversion (with antero-posterior electrode position)
AL PositionActive comparatorCardioversion with antero-lateral electrode position
Receives: Procedure: external electrical cardioversion (with antero-lateral electrode position)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 30 seconds after cardioversion

Secondary outcomes (3)

  1. Mean Number of Cardioversion Shocks

    Measured: 30 seconds after cardioversion

  2. Mean Energy Requirement for Successful Cardioversion

    Overall energy in the mean (number of joules) necessary for successful cardioversion of all patients per group.

    Measured: 30 seconds after cardioversion

  3. 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.

    Measured: 30 seconds after cardioversion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Mar 2009 (estimated)
  2. Study startJan 2005
  3. Primary completionDec 2005
  4. Study completionDec 2005

Why it stopped: Statistical interim analysis showed valid and significant results

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
96 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00860314
Sponsor's protocol ID
UKE-2383
Acronym
APOVERSAL
Status last verified
Aug 2015
First submitted
10 Nov 2008
Last updated
27 Aug 2015
Data monitoring committee
No

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. doi: 10.1161/01.cir.70.2.303.

    PubMed 6733884

  • 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.

    PubMed 12414201

  • 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.

    PubMed 14739731

  • 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.

    PubMed 7266602

  • 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.

    PubMed 10573502

  • 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.

    PubMed 14560770

  • 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.

    PubMed 10568674

  • 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.

    PubMed 8903272

  • 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.

    PubMed 7790013

  • 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.

    PubMed 15734772

Questions about this trial

What is this clinical trial studying?

A study testing external electrical cardioversion (with antero-posterior electrode position) and external electrical cardioversion (with antero-lateral electrode position) in people with Atrial Flutter, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 27 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Mar 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Successfully Cardioverted Participants for Each Electrode Position (time frame: 30 seconds after cardioversion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00860314, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2015.

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