Electrode Positions in Cardioverting Atrial Fibrillation

Study Overview
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Brief Summary
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Atrial fibrillation is the most common heart rhythm disorder, and the incidence is rapidly increasing. Cardioversion using an electrical shock (DC-cardioversion) is an important treatment to reduce symptoms and improve patient's quality-of-life. The treatment is performed by applying gel electrodes to the chest. Cardioversion is not always successful, and it is unknown which electrode-position provides the optimal efficacy. This study aims to compare two electrode positions, which are in clinical use: Anterior-posterior (left front and left back) versus anterior-lateral (right front and left side of the chest).

Official Title
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Comparison of Anterior-Posterior Versus Anterior-Lateral Electrode Position in Cardioverting Atrial Fibrillation - A Randomized Clinical Trial

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Device: Anterior-posterior electrode position
* Device: Anterior-lateral electrode position


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Atrial fibrillation (documented on an ECG-12) Able and willing to sign informed consent Age ≥ 18 years Anticoagulation according to guidelines (Patients with atrial fibrillation for >48 hours will be required to have a documented weekly international normalized ratio (INR) ≥2.0 (including within 48 hours of cardioversion) or treatment with non-vitamin K oral anticoagulant for three weeks or longer. Alternatively, a transoesophageal echocardiogram documenting the absence of intracardiac thrombi is accepted and cardioversion can be performed on treatment with low molecular weight heparin). Exclusion Criteria: Implanted pacemaker and/or cardioverter defibrillator (ICD) Prior enrollment in the trial Hemodynamically unstable atrial fibrillation Untreated hyperthyroidism Known or suspected pregnancy

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: Anterior-posterior electrode position<br>The anterior electrode is placed in the left parasternal area (precordium). The posterior electrode is placed in the left lower-scapular region with the electrode edge left to the spinal column. | Device: Anterior-posterior electrode position<br>* Escalating energy shocks (100 J, 150 J, 200 J, 360 J) using anterior-posterior electrode position<br>* Other names: LIFEPAK 20, Physio-Control/Stryker;|
| Active Comparator: Anterior-lateral electrode position<br>The anterior electrode is placed in the right parasternal area below the clavicle. The lateral electrode is placed with the center of the electrode in the left mid-axillary line in level with the V6 electrocardiogram electrode. | Device: Anterior-lateral electrode position<br>* Escalating energy shocks (100 J, 150 J, 200 J, 360 J) using anterior-lateral electrode position<br>* Other names: LIFEPAK 20, Physio-Control/Stryker;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy: First shock success | The primary endpoint will be first shock efficacy, i.e. the proportion of patients in sinus rhythm for at least one minute immediately after an initial shock of 100 J. | Immediately after first cardioversion attempt. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy: Successful cardioversion | The secondary efficacy endpoint will be cardioversion success, i.e. the proportion of patients in sinus rhythm for at least one minute after end of protocol. | One minute after cardioversion | 
| Safety: Number of participants with arrhythmic events during and after cardioversion | Secondary safety endpoints will be arrhythmia during and after cardioversion (asystole, transient bradycardia, ventricular arrhythmia, atrioventricular block, recurrence of atrial fibrillation) | Within 2 hours after cardioversion (until discharge) | 
| Safety: Number of participants with skin-discomfort, skin burns or itching | Patient-reported peri-procedural discomfort when asked at discharge. | Two hours after cardioversion (at discharge) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardioversion, Electrode position