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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prospective, Randomized Single-center Study for Efficacy of Antero-posterior and Antero-lateral Electrode Position for External Electrical Cardioversion of Typical Atrial Flutter

Conditions
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Atrial Flutter

Intervention / Treatment
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* Procedure: external electrical cardioversion (with antero-posterior electrode position)
* Procedure: external electrical cardioversion (with antero-lateral electrode position)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: AP Position<br>Cardioversion with antero-posterior electrode position | Procedure: external electrical cardioversion (with antero-posterior electrode position)<br>* 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<br>* Other names: countershock treatment;|
| Active Comparator: AL Position<br>Cardioversion with antero-lateral electrode position | Procedure: external electrical cardioversion (with antero-lateral electrode position)<br>* 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<br>* Other names: countershock treatment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Number of Cardioversion Shocks |  | 30 seconds after cardioversion | 
| Mean Energy Requirement for Successful 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 | Number of participants successfully cardioverted to normal sinus rhythm with one shock of 50 Joules. | 30 seconds after cardioversion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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external electrical cardioversion, typical atrial flutter, electrode position, antero-lateral, antero-posterior, biphasic cardioversion, step-up protocol