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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00933634
Enrollment
247
Registered
2009-07-07
Start date
2006-01-31
Completion date
2008-11-30
Last updated
2009-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Keywords

atrial fibrillation, electrical cardioversion, pharmacological cardioversion

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.

Interventions

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 (2 mg/kg bolus) was administered to obtain pharmacolgic sinus rhythm conversion.

Sponsors

Valduce Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Efficacy of intervention (Electrical and pharmacological cardioversion) in restoring sinus rythmduring emergency department stay

Secondary

MeasureTime frame
Number of adverse events related to electrical and pharmacological cardioversionduring emergency department stay
recurrence of atrial fibrillationwithin 2 months

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 29, 2026