Efficacy and Safety of Electrical Versus Pharmacological Cardioversion in Early Atrial Fibrillation
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
electrical cardioversion
propafenone
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring atrial fibrillation, electrical cardioversion, pharmacological cardioversion
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
- sepsis
- fever
- hypothermia
- untreated hyperthyroidism
- use of antiarrhythmic drugs
- high embolic risk
- unclear duration of symptoms
Sites / Locations
- Emergency Unit - Valduce Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
electrical cardioversion
propafenone
Arm Description
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.
Propafenone (2 mg/kg bolus) was administered iv to obtain pharmacologic sinus rhythm conversion.
Outcomes
Primary Outcome Measures
Efficacy of intervention (Electrical and pharmacological cardioversion) in restoring sinus rythm
Secondary Outcome Measures
Number of adverse events related to electrical and pharmacological cardioversion
recurrence of atrial fibrillation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00933634
Brief Title
Efficacy and Safety of Electrical Versus Pharmacological Cardioversion in Early Atrial Fibrillation
Official Title
Efficacy and Safety of Electrical Versus Pharmacological Cardioversion in Early Atrial Fibrillation: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
November 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Valduce Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
atrial fibrillation, electrical cardioversion, pharmacological cardioversion
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
247 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
electrical cardioversion
Arm Type
Experimental
Arm Description
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.
Arm Title
propafenone
Arm Type
Active Comparator
Arm Description
Propafenone (2 mg/kg bolus) was administered iv to obtain pharmacologic sinus rhythm conversion.
Intervention Type
Procedure
Intervention Name(s)
electrical cardioversion
Intervention Description
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 Type
Drug
Intervention Name(s)
propafenone
Intervention Description
Propafenone (2 mg/kg bolus) was administered to obtain pharmacolgic sinus rhythm conversion.
Primary Outcome Measure Information:
Title
Efficacy of intervention (Electrical and pharmacological cardioversion) in restoring sinus rythm
Time Frame
during emergency department stay
Secondary Outcome Measure Information:
Title
Number of adverse events related to electrical and pharmacological cardioversion
Time Frame
during emergency department stay
Title
recurrence of atrial fibrillation
Time Frame
within 2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
sepsis
fever
hypothermia
untreated hyperthyroidism
use of antiarrhythmic drugs
high embolic risk
unclear duration of symptoms
Facility Information:
Facility Name
Emergency Unit - Valduce Hospital
City
Como
ZIP/Postal Code
22100
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
21422032
Citation
Bellone A, Etteri M, Vettorello M, Bonetti C, Clerici D, Gini G, Maino C, Mariani M, Natalizi A, Nessi I, Rampoldi A, Colombo L. Cardioversion of acute atrial fibrillation in the emergency department: a prospective randomised trial. Emerg Med J. 2012 Mar;29(3):188-91. doi: 10.1136/emj.2010.109702. Epub 2011 Mar 21.
Results Reference
derived
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Efficacy and Safety of Electrical Versus Pharmacological Cardioversion in Early Atrial Fibrillation
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