Atrial FibrillationNCT00933634
Efficacy and Safety of Electrical Versus Pharmacological Cardioversion in Early Atrial Fibrillation
A study testing electrical cardioversion and propafenone in people with Atrial Fibrillation, run by Valduce Hospital at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- electrical cardioversion and propafenone
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 247 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2006to Nov 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- atrial fibrillation of less than 48 hours' duration.
Who cannot join
- AF of more than 48 hours'
- hemodynamic instability
- acute onset atrial fibrillation due to acute coronary syndrome
- electrolyte disturbances
- sepsis
- fever
Show all 11Show fewer
- hypothermia
- untreated hyperthyroidism
- use of antiarrhythmic drugs
- high embolic risk
- unclear duration of symptoms
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Electrical Versus Pharmacological Cardioversion in Early Atrial Fibrillation: a Randomized Controlled Trial
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.
- Conditions
- Atrial Fibrillation
- Being tested
- electrical cardioversion, propafenone
- Keywords
- atrial fibrillation, electrical cardioversion, pharmacological cardioversion
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electrical cardioversionProcedure or surgery
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.
propafenoneDrug
Propafenone (2 mg/kg bolus) was administered to obtain pharmacolgic sinus rhythm conversion.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: electrical cardioversion |
| propafenone | Active comparator | Propafenone (2 mg/kg bolus) was administered iv to obtain pharmacologic sinus rhythm conversion. Receives: Drug: propafenone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of intervention (Electrical and pharmacological cardioversion) in restoring sinus rythm
Measured: during emergency department stay
Secondary outcomes (2)
Number of adverse events related to electrical and pharmacological cardioversion
Measured: during emergency department stay
recurrence of atrial fibrillation
Measured: within 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2009 (estimated)
- Study startJan 2006
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 247 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Valduce Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00933634
- Sponsor's protocol ID
- ECVPCV-001
- Status last verified
- Jul 2009
- First submitted
- 2 Jul 2009
- Last updated
- 7 Jul 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21422032
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Electrical Versus Pharmacological Cardioversion in Early Atrial Fibrillation: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00933634
- Acronym / sponsor ID
- ECVPCV-001
- Conditions
- Atrial Fibrillation
- Keywords
- atrial fibrillation, electrical cardioversion, pharmacological cardioversion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 247 participants (estimated)
- Lead sponsor
- Valduce HospitalUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 7 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| electrical cardioversion | Experimental | Procedure: electrical cardioversionPatients 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 | Active comparator | Drug: propafenonePropafenone (2 mg/kg bolus) was administered iv to obtain pharmacologic sinus rhythm conversion. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- atrial fibrillation of less than 48 hours' duration.
Key exclusion criteria (11 listed)
- AF of more than 48 hours'
- hemodynamic instability
- acute onset atrial fibrillation due to acute coronary syndrome
- electrolyte disturbances
- sepsis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| electrical cardioversionExternal 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 or surgery | electrical cardioversion |
| propafenonePropafenone (2 mg/kg bolus) was administered to obtain pharmacolgic sinus rhythm conversion. | Drug | propafenone |
Primary outcome
Efficacy of intervention (Electrical and pharmacological cardioversion) in restoring sinus rythm
Time frame: during emergency department stay
2 secondary outcomes
Number of adverse events related to electrical and pharmacological cardioversion
Time frame: during emergency department stay
recurrence of atrial fibrillation
Time frame: within 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2009.
- Derived from this study: PubMed 21422032Bellone 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electrical cardioversion and propafenone in people with Atrial Fibrillation, run by Valduce Hospital at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of intervention (Electrical and pharmacological cardioversion) in restoring sinus rythm (time frame: during emergency department stay). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00933634, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2009.