Atrial FibrillationFinCVNCT01380574
Safety of Cardioversion of Acute Atrial Fibrillation
An observational study of Atrial Fibrillation, run by Turku University Hospital at 3 sites in Finland.
Trial summary
The purpose of this study is to investigate the complications of cardioversion of acute (<48 hours duration) atrial fibrillation (AF). Primary Outcome Measures: Incidence and predictors of thromboembolic complications, especially stroke, and death <31 days after cardioversion of acute AF Secondary Outcome Measures… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 7,700 participants
- Where
- 3 sitesFinland
- Study dates
- Jun 2011to Jun 2012
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients admitted to emergency room because of acute AF in whom electrical or pharmacological cardioversion was attempted <48 from the beginning of the symptoms.
Who may be able to join
- patients admitted to emergency room because of acute AF in whom electrical or pharmacological cardioversion was attempted <48 from the beginning of the symptoms
Who cannot join
- duration of the AF is unknown or >48 hours
Trial locations and contacts
3 sites in 1 country.
Finland3 sites
Kuopio University Hospital
Kuopio, 70211
Satakunta Central Hospital
Pori, 28500
Turku University Hospital
Turku, 20520
About this study
The purpose of this study is to investigate the complications of cardioversion of acute (<48 hours duration) atrial fibrillation (AF).
Primary Outcome Measures:
- Incidence and predictors of thromboembolic complications, especially stroke, and death <31 days after cardioversion of acute AF
Secondary Outcome Measures:
- Number of therapy non-responder and early recurrence of AF
- Bleeding complications during the 31 days follow-up
- Hemodynamic complications of cardioversion
Estimated Enrollment: 3000 cases
Study Start Date: Jun 2011
Estimated Study Completion Date: December 2011
Read the detailed description
It has been a common practice to perform cardioversion of acute (<48 hour) AF without any anticoagulation. The new European guidelines recommend that anticoagulation should be started already before cardioversion in all patients with CHADS2VASC score indicating need for long-term oral anticoagulation. The evidence behind these guidelines is, however, scarce. In this retrospective study we collect data on the safety of acute AF cardioversion from emergency rooms of two university hospitals and one secondary referral center from the years 2003-2010.
Inclusion criteria:
All patients admitted to emergency room because of acute AF in whom electrical or pharmacological cardioversion was attempted <48 from the beginning of the symptoms.
- Conditions
- Atrial Fibrillation
- Keywords
- atrial fibrillation, cardioversion, stroke, thromboembolism
- Medical subject headings
- Atrial Fibrillation, Stroke, Thromboembolism
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and predictors of thromboembolic complications, especially stroke, and death <31 days after cardioversion of acute AF
Measured: 31 days
Secondary outcomes (3)
Number of therapy non-responder and early recurrence of AF
Measured: 31 days
Bleeding complications during the 31 days follow-up
Measured: 31 days
Hemodynamic complications of cardioversion
Measured: 31 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionMay 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Turku University HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 7,700 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Juhani Airaksinen, Turku University Hospital
- Investigators
- Juhani Airaksinen, Professor, Principal investigator, Turku University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01380574
- Sponsor's protocol ID
- K23
- Acronym
- FinCV
- Status last verified
- Jun 2012
- First submitted
- 16 Jun 2011
- Last updated
- 28 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Jaakkola S, Nuotio I, Hartikainen JEK, Airaksinen KEJ. Early Cardioversion for Acute Atrial Fibrillation in Low Stroke Risk Patients Is Safe Without Anticoagulation. J Am Coll Cardiol. 2020 Jul 14;76(2):226-227. doi: 10.1016/j.jacc.2020.04.076. No abstract available.
PubMed 32646574Jaakkola J, Hartikainen JE, Kiviniemi T, Nuotio I, Nammas W, Gronberg T, Karmi A, Ylitalo A, Airaksinen KE. Ventricular rate during acute atrial fibrillation and outcome of electrical cardioversion: The FinCV Study. Ann Med. 2015 Jun;47(4):341-5. doi: 10.3109/07853890.2015.1031821. Epub 2015 May 6.
PubMed 25943162Nuotio I, Hartikainen JE, Gronberg T, Biancari F, Airaksinen KE. Time to cardioversion for acute atrial fibrillation and thromboembolic complications. JAMA. 2014 Aug 13;312(6):647-9. doi: 10.1001/jama.2014.3824. No abstract available.
PubMed 25117135Airaksinen KE, Gronberg T, Nuotio I, Nikkinen M, Ylitalo A, Biancari F, Hartikainen JE. Thromboembolic complications after cardioversion of acute atrial fibrillation: the FinCV (Finnish CardioVersion) study. J Am Coll Cardiol. 2013 Sep 24;62(13):1187-92. doi: 10.1016/j.jacc.2013.04.089. Epub 2013 Jul 10.
PubMed 23850908
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Cardioversion of Acute Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT01380574
- Acronym / sponsor ID
- FinCV / K23
- Conditions
- Atrial Fibrillation
- Keywords
- atrial fibrillation, cardioversion, stroke, thromboembolism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7,700 participants (actual)
- Lead sponsor
- Turku University HospitalOther government
- Study start
- Jun 2011
- Primary completion
- May 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 27 Jun 2011 (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 purpose of this study is to investigate the complications of cardioversion of acute (<48 hours duration) atrial fibrillation (AF).
Primary Outcome Measures:
- Incidence and predictors of thromboembolic complications, especially stroke, and death <31 days after cardioversion of acute AF
Secondary Outcome Measures:
- Number of therapy non-responder and early recurrence of AF
- Bleeding complications during the 31 days follow-up
- Hemodynamic complications of cardioversion
Estimated Enrollment: 3000 cases
Study Start Date: Jun 2011
Estimated Study Completion Date: December 2011
Detailed description
It has been a common practice to perform cardioversion of acute (<48 hour) AF without any anticoagulation. The new European guidelines recommend that anticoagulation should be started already before cardioversion in all patients with CHADS2VASC score indicating need for long-term oral anticoagulation. The evidence behind these guidelines is, however, scarce. In this retrospective study we collect data on the safety of acute AF cardioversion from emergency rooms of two university hospitals and one secondary referral center from the years 2003-2010.
Inclusion criteria:
All patients admitted to emergency room because of acute AF in whom electrical or pharmacological cardioversion was attempted <48 from the beginning of the symptoms.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients admitted to emergency room because of acute AF in whom electrical or pharmacological cardioversion was attempted <48 from the beginning of the symptoms.
Key inclusion criteria (1 listed)
- patients admitted to emergency room because of acute AF in whom electrical or pharmacological cardioversion was attempted <48 from the beginning of the symptoms
Key exclusion criteria (1 listed)
- duration of the AF is unknown or >48 hours
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence and predictors of thromboembolic complications, especially stroke, and death <31 days after cardioversion of acute AF
Time frame: 31 days
3 secondary outcomes
Number of therapy non-responder and early recurrence of AF
Time frame: 31 days
Bleeding complications during the 31 days follow-up
Time frame: 31 days
Hemodynamic complications of cardioversion
Time frame: 31 days
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 28 Jun 2012.
- Derived from this study: PubMed 32646574Jaakkola S, Nuotio I, Hartikainen JEK, Airaksinen KEJ. Early Cardioversion for Acute Atrial Fibrillation in Low Stroke Risk Patients Is Safe Without Anticoagulation. J Am Coll Cardiol. 2020 Jul 14;76(2):226-227. doi: 10.1016/j.jacc.2020.04.076. No abstract available.
- Derived from this study: PubMed 25943162Jaakkola J, Hartikainen JE, Kiviniemi T, Nuotio I, Nammas W, Gronberg T, Karmi A, Ylitalo A, Airaksinen KE. Ventricular rate during acute atrial fibrillation and outcome of electrical cardioversion: The FinCV Study. Ann Med. 2015 Jun;47(4):341-5. doi: 10.3109/07853890.2015.1031821. Epub 2015 May 6.
- Derived from this study: PubMed 25117135Nuotio I, Hartikainen JE, Gronberg T, Biancari F, Airaksinen KE. Time to cardioversion for acute atrial fibrillation and thromboembolic complications. JAMA. 2014 Aug 13;312(6):647-9. doi: 10.1001/jama.2014.3824. No abstract available.
- Derived from this study: PubMed 23850908Airaksinen KE, Gronberg T, Nuotio I, Nikkinen M, Ylitalo A, Biancari F, Hartikainen JE. Thromboembolic complications after cardioversion of acute atrial fibrillation: the FinCV (Finnish CardioVersion) study. J Am Coll Cardiol. 2013 Sep 24;62(13):1187-92. doi: 10.1016/j.jacc.2013.04.089. Epub 2013 Jul 10.
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Atrial Fibrillation (AF)
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.
Juhani Airaksinen, Professor principal investigator
Turku University Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Turku University Hospital at 3 sites in Finland.
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 1 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 28 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Finland. 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?
Incidence and predictors of thromboembolic complications, especially stroke, and death <31 days after cardioversion of acute AF (time frame: 31 days). 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 NCT01380574, which also lists 4 linked publications.
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 28 Jun 2012.