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Clinical Trials/NCT00933634
NCT00933634
Completed
Not Applicable

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

Valduce Hospital1 site in 1 country247 target enrollmentJanuary 2006

Overview

Phase
Not Applicable
Intervention
electrical cardioversion
Conditions
Atrial Fibrillation
Sponsor
Valduce Hospital
Enrollment
247
Locations
1
Primary Endpoint
Efficacy of intervention (Electrical and pharmacological cardioversion) in restoring sinus rythm
Status
Completed
Last Updated
16 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2006
End Date
November 2008
Last Updated
16 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Valduce Hospital

Eligibility Criteria

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
  • hypothermia
  • untreated hyperthyroidism
  • use of antiarrhythmic drugs
  • high embolic risk
  • unclear duration of symptoms

Arms & Interventions

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.

Intervention: electrical cardioversion

propafenone

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

Intervention: propafenone

Outcomes

Primary Outcomes

Efficacy of intervention (Electrical and pharmacological cardioversion) in restoring sinus rythm

Time Frame: during emergency department stay

Secondary Outcomes

  • Number of adverse events related to electrical and pharmacological cardioversion(during emergency department stay)
  • recurrence of atrial fibrillation(within 2 months)

Study Sites (1)

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