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

Not Applicable

Completed

• Conditions: Atrial Fibrillation
• Interventions: Procedure: electrical cardioversion; Drug: propafenone

• Registration Number: NCT00933634
• Lead Sponsor: Valduce Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01
• Primary Completion: 2008-11
• Study Completion: 2008-11
• Status Verified: 2009-07
• Study First Submitted: 2009-07-02
• Study First Submitted QC: 2009-07-02
• Last Update Submitted: 2009-07-02
• Study First Posted: 2009-07-07
• Last Update Posted: 2009-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 247

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
electrical cardioversion	electrical cardioversion	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.
propafenone	propafenone	Propafenone (2 mg/kg bolus) was administered iv to obtain pharmacologic sinus rhythm conversion.

Primary Outcome Measures

Name	Time	Method
Efficacy of intervention (Electrical and pharmacological cardioversion) in restoring sinus rythm	during emergency department stay

Secondary Outcome Measures

Name	Time	Method
Number of adverse events related to electrical and pharmacological cardioversion	during emergency department stay
recurrence of atrial fibrillation	within 2 months

Trial Locations

Locations (1)

Emergency Unit - Valduce Hospital; 🇮🇹 Como, Italy