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OpenTrials
Completed

NCT Number: NCT00933634

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

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emergency Unit - Valduce Hospital

Como, 22100, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Electrical cardioversion

Procedure

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

Drug

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

Primary outcomes

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

    Time frame: during emergency department stay

Secondary outcomes

  1. Number of adverse events related to electrical and pharmacological cardioversion

    Time frame: during emergency department stay

  2. recurrence of atrial fibrillation

    Time frame: within 2 months

Sponsors and collaborators

Lead sponsor

Valduce Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Jul 7, 2009
Registry last updated
Jul 7, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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