Efficacy and Safety of Electrical Versus Pharmacological Cardioversion in Early Atrial Fibrillation - Full Text View

Sponsor:	Valduce Hospital
Information provided by:	Valduce Hospital
ClinicalTrials.gov Identifier:	NCT00933634

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:	Treatment, Randomized, Single Blind (Investigator), Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title:	Efficacy and Safety of Electrical Versus Pharmacological Cardioversion in Early Atrial Fibrillation: a Randomized Controlled Trial

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Atrial Fibrillation

Drug Information available for: Propafenone hydrochloride Propafenone

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
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 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: Active Comparator 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

Responsible Party:	Valduce Hospital ( Andrea Bellone )
Study ID Numbers:	ECVPCV-001
Study First Received:	July 2, 2009
Last Updated:	July 2, 2009
ClinicalTrials.gov Identifier:	NCT00933634 History of Changes
Health Authority:	Italy: Ethics Committee

Keywords provided by Valduce Hospital:

atrial fibrillation
electrical cardioversion
pharmacological cardioversion

Additional relevant MeSH terms:

Propafenone
Pathologic Processes
Heart Diseases
Therapeutic Uses
Cardiovascular Diseases

Cardiovascular Agents
Anti-Arrhythmia Agents
Atrial Fibrillation
Pharmacologic Actions
Arrhythmias, Cardiac

ClinicalTrials.gov processed this record on February 08, 2010