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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00933634
First Posted: July 7, 2009
Last Update Posted: July 7, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Valduce Hospital
  Purpose
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.

Condition Intervention
Atrial Fibrillation Procedure: electrical cardioversion Drug: propafenone

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Electrical Versus Pharmacological Cardioversion in Early Atrial Fibrillation: a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Valduce Hospital:

Primary Outcome Measures:
  • Efficacy of intervention (Electrical and pharmacological cardioversion) in restoring sinus rythm [ Time Frame: during emergency department stay ]

Secondary Outcome Measures:
  • Number of adverse events related to electrical and pharmacological cardioversion [ Time Frame: during emergency department stay ]
  • recurrence of atrial fibrillation [ Time Frame: within 2 months ]

Estimated Enrollment: 247
Study Start Date: January 2006
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Procedure: electrical cardioversion
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.
Active Comparator: propafenone
Propafenone (2 mg/kg bolus) was administered iv to obtain pharmacologic sinus rhythm conversion.
Drug: propafenone
Propafenone (2 mg/kg bolus) was administered to obtain pharmacolgic sinus rhythm conversion.

  Eligibility

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • sepsis
  • fever
  • hypothermia
  • untreated hyperthyroidism
  • use of antiarrhythmic drugs
  • high embolic risk
  • unclear duration of symptoms
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00933634


Locations
Italy
Emergency Unit - Valduce Hospital
Como, Italy, 22100
Sponsors and Collaborators
Valduce Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Andrea Bellone, Valduce Hospital
ClinicalTrials.gov Identifier: NCT00933634     History of Changes
Other Study ID Numbers: ECVPCV-001
First Submitted: July 2, 2009
First Posted: July 7, 2009
Last Update Posted: July 7, 2009
Last Verified: July 2009

Keywords provided by Valduce Hospital:
atrial fibrillation
electrical cardioversion
pharmacological cardioversion

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Propafenone
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action