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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

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring atrial fibrillation, electrical cardioversion, pharmacological cardioversion

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

NCT ID

NCT00933634

First Posted

July 2, 2009

Last Updated

July 2, 2009

Sponsor

Valduce Hospital

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

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

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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