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

This study has been completed.
Sponsor:
Information provided by:
Valduce Hospital
ClinicalTrials.gov Identifier:
NCT00933634
First received: July 2, 2009
Last updated: NA
Last verified: July 2009
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of adverse events related to electrical and pharmacological cardioversion [ Time Frame: during emergency department stay ] [ Designated as safety issue: Yes ]
  • recurrence of atrial fibrillation [ Time Frame: within 2 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00933634

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

No publications provided by Valduce Hospital

Additional 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
Study First Received: July 2, 2009
Last Updated: July 2, 2009
Health Authority: Italy: Ethics Committee

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
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013