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

Valduce Hospital

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Procedure: electrical cardioversion; Drug: propafenone

Study type: Interventional

Funder types: Other

Identifiers

NCT00933634

ECVPCV-001

Details and patient eligibility

About

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.

Enrollment: 247 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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247 participants in 2 patient groups

electrical cardioversion

Experimental group

Description:

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.

Treatment:

Procedure: electrical cardioversion

propafenone

Active Comparator group

Description:

Propafenone (2 mg/kg bolus) was administered iv to obtain pharmacologic sinus rhythm conversion.

Treatment:

Drug: propafenone