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

NCT ID: NCT00933634

Last Updated: 2009-07-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

247 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2008-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Atrial Fibrillation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

electrical cardioversion

Intervention Type PROCEDURE

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

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

Group Type ACTIVE_COMPARATOR

propafenone

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type PROCEDURE

propafenone

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Valduce Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Valduce Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Emergency Unit - Valduce Hospital

Como, , Italy

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Italy

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 21422032 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ECVPCV-001

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.