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

Primary Purpose

Atrial Flutter

Status
Terminated
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
external electrical cardioversion (with antero-posterior electrode position)
external electrical cardioversion (with antero-lateral electrode position)
Sponsored by
Universitätsklinikum Hamburg-Eppendorf
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Flutter focused on measuring external electrical cardioversion, typical atrial flutter, electrode position, antero-lateral, antero-posterior, biphasic cardioversion, step-up protocol

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Hamburg-Eppendorf, Heart Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

AP Position

AL Position

Arm Description

Cardioversion with antero-posterior electrode position

Cardioversion with antero-lateral electrode position

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Mean Number of Cardioversion Shocks
Mean Energy Requirement for Successful Cardioversion
Overall energy in the mean (number of joules) necessary for successful cardioversion of all patients per group.
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.

Full Information

First Posted
November 10, 2008
Last Updated
August 17, 2015
Sponsor
Universitätsklinikum Hamburg-Eppendorf
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1. Study Identification

Unique Protocol Identification Number
NCT00860314
Brief Title
Antero-posterior Versus Antero-lateral Electrode Position for Electrical Cardioversion of Typical Atrial Flutter
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Terminated
Why Stopped
Statistical interim analysis showed valid and significant results
Study Start Date
January 2005 (undefined)
Primary Completion Date
December 2005 (Actual)
Study Completion Date
December 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitätsklinikum Hamburg-Eppendorf

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Flutter
Keywords
external electrical cardioversion, typical atrial flutter, electrode position, antero-lateral, antero-posterior, biphasic cardioversion, step-up protocol

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
96 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AP Position
Arm Type
Active Comparator
Arm Description
Cardioversion with antero-posterior electrode position
Arm Title
AL Position
Arm Type
Active Comparator
Arm Description
Cardioversion with antero-lateral electrode position
Intervention Type
Procedure
Intervention Name(s)
external electrical cardioversion (with antero-posterior electrode position)
Other Intervention Name(s)
biphasic cardioversion, countershock treatment
Intervention Description
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
Intervention Name(s)
external electrical cardioversion (with antero-lateral electrode position)
Other Intervention Name(s)
biphasic cardioversion, countershock treatment
Intervention Description
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
Primary Outcome Measure Information:
Title
Number of Successfully Cardioverted Participants for Each Electrode Position
Description
After restoration of normal sinus rhythm for 30 seconds and longer by electrical countershock a cardioversion is counted as successful.
Time Frame
30 seconds after cardioversion
Secondary Outcome Measure Information:
Title
Mean Number of Cardioversion Shocks
Time Frame
30 seconds after cardioversion
Title
Mean Energy Requirement for Successful Cardioversion
Description
Overall energy in the mean (number of joules) necessary for successful cardioversion of all patients per group.
Time Frame
30 seconds after cardioversion
Title
Number of Participants Succesfully Cardioverted With First Shock in Each Electrode Position
Description
Number of participants successfully cardioverted to normal sinus rhythm with one shock of 50 Joules.
Time Frame
30 seconds after cardioversion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephan Willems, Prof. Dr.
Organizational Affiliation
Oberarzt
Official's Role
Study Chair
Facility Information:
Facility Name
University Hospital Hamburg-Eppendorf, Heart Center
City
Hamburg
ZIP/Postal Code
20246
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
6733884
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. doi: 10.1161/01.cir.70.2.303.
Results Reference
background
PubMed Identifier
12414201
Citation
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.
Results Reference
background
PubMed Identifier
14739731
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. doi: 10.1023/B:CEPR.0000012399.96959.ab.
Results Reference
background
PubMed Identifier
7266602
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. doi: 10.1056/NEJM198109173051202.
Results Reference
background
PubMed Identifier
10573502
Citation
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.
Results Reference
background
PubMed Identifier
14560770
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. doi: 10.1109/TBME.2003.816082.
Results Reference
background
PubMed Identifier
10568674
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. doi: 10.1016/s0002-9149(99)00715-8.
Results Reference
background
PubMed Identifier
8903272
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. doi: 10.1016/s0002-9149(96)00562-0.
Results Reference
background
PubMed Identifier
7790013
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. doi: 10.1109/10.387196.
Results Reference
background
PubMed Identifier
15734772
Citation
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.
Results Reference
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Links:
URL
http://www.uke.de
Description
Homepage of University Hospital Hamburg-Eppendorf

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

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