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

August 17, 2015 updated by: Prof. Dr. Stephan Willems, Universitätsklinikum Hamburg-Eppendorf

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

96

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hamburg, Germany, 20246
        • University Hospital Hamburg-Eppendorf, Heart Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: AP Position
Cardioversion with antero-posterior electrode position
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
Other Names:
  • biphasic cardioversion
  • countershock treatment
ACTIVE_COMPARATOR: AL Position
Cardioversion with antero-lateral electrode position
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
Other Names:
  • biphasic cardioversion
  • countershock treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Successfully Cardioverted Participants for Each Electrode Position
Time Frame: 30 seconds after cardioversion
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Number of Cardioversion Shocks
Time Frame: 30 seconds after cardioversion
30 seconds after cardioversion
Mean Energy Requirement for Successful Cardioversion
Time Frame: 30 seconds after cardioversion
Overall energy in the mean (number of joules) necessary for successful cardioversion of all patients per group.
30 seconds after cardioversion
Number of Participants Succesfully Cardioverted With First Shock in Each Electrode Position
Time Frame: 30 seconds after cardioversion
Number of participants successfully cardioverted to normal sinus rhythm with one shock of 50 Joules.
30 seconds after cardioversion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Investigators

  • Study Chair: Stephan Willems, Prof. Dr., Oberarzt

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Primary Completion (ACTUAL)

December 1, 2005

Study Completion (ACTUAL)

December 1, 2005

Study Registration Dates

First Submitted

November 10, 2008

First Submitted That Met QC Criteria

March 11, 2009

First Posted (ESTIMATE)

March 12, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

August 27, 2015

Last Update Submitted That Met QC Criteria

August 17, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UKE-2383

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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