Efficacy and Safety of Electrical Versus Pharmacological Cardioversion in Early Atrial Fibrillation

Study Overview
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Brief Summary
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The optimal strategy to restore sinus rhythm in patients with atrial fibrillation (AF) of less than 48 hours' duration is still controversial. The investigators performed a controlled single-center trial to compare electrical and pharmacological (propafenone) cardioversion to restore the sinus rhythm in selected patients with acute atrial fibrillation.

Official Title
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Efficacy and Safety of Electrical Versus Pharmacological Cardioversion in Early Atrial Fibrillation: a Randomized Controlled Trial

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Procedure: electrical cardioversion
* Drug: propafenone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: atrial fibrillation of less than 48 hours' duration. Exclusion Criteria: AF of more than 48 hours' hemodynamic instability acute onset atrial fibrillation due to acute coronary syndrome electrolyte disturbances sepsis fever hypothermia untreated hyperthyroidism use of antiarrhythmic drugs high embolic risk unclear duration of symptoms

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: electrical cardioversion<br>Patients were sedated with propofol and external cardioversion was performed in anteroposterior position (right sternal body at the third intercostal space-angle of the left scapula). Patients were submitted to a biphasic wave-form sequential shock of 100-150-200 J, if necessary. | Procedure: electrical cardioversion<br>* External cardioversion was performed in anteroposterior position (right sternal body at the third intercostal space-angle of the left scapula); patients were submitted to a biphasic wave-form sequential shock of 100-150-200 J, if necessary.<br>|
| Active Comparator: propafenone<br>Propafenone (2 mg/kg bolus) was administered iv to obtain pharmacologic sinus rhythm conversion. | Drug: propafenone<br>* Propafenone (2 mg/kg bolus) was administered to obtain pharmacolgic sinus rhythm conversion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of intervention (Electrical and pharmacological cardioversion) in restoring sinus rythm |  | during emergency department stay | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse events related to electrical and pharmacological cardioversion |  | during emergency department stay | 
| recurrence of atrial fibrillation |  | within 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atrial fibrillation, electrical cardioversion, pharmacological cardioversion