NCT00933634

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
247

participants targeted

Target at P50-P75 for not_applicable atrial-fibrillation

Timeline
Completed

Started Jan 2006

Typical duration for not_applicable atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 2, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 7, 2009

Completed
Last Updated

July 7, 2009

Status Verified

July 1, 2009

Enrollment Period

2.8 years

First QC Date

July 2, 2009

Last Update Submit

July 2, 2009

Conditions

Atrial Fibrillation

Keywords

atrial fibrillationelectrical cardioversionpharmacological cardioversion

Outcome Measures

Primary Outcomes (1)

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

    during emergency department stay

Secondary Outcomes (2)

  • Number of adverse events related to electrical and pharmacological cardioversion

    during emergency department stay

  • recurrence of atrial fibrillation

    within 2 months

Study Arms (2)

electrical cardioversion

EXPERIMENTAL

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

propafenone

ACTIVE COMPARATOR

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

Drug: propafenone

Interventions

electrical cardioversionPROCEDURE

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.

electrical cardioversion
propafenoneDRUG

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

propafenone

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • atrial fibrillation of less than 48 hours' duration.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emergency Unit - Valduce Hospital

Como, 22100, Italy

Location

Related Publications (1)

  • 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.

    PMID: 21422032DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Electric CountershockPropafenone

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPropiophenonesKetonesOrganic Chemicals

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 2, 2009

First Posted

July 7, 2009

Study Start

January 1, 2006

Primary Completion

November 1, 2008

Study Completion

November 1, 2008

Last Updated

July 7, 2009

Record last verified: 2009-07

Locations

IT(1)