Atrial FibrillationFinCV2NCT02850679
FINnish CardioVersion Study II
An observational study of Atrial Fibrillation, run by University of Turku at 1 site in Finland.
Trial summary
This is a retrospective multi-center patient cohort study investigating patients with persistent atrial fibrillation (AF) and elective cardioversion (ECV). The aim is to identify clinical predictors for ineffective ECV to improve management quality of persistent AF. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 1,342 participants
- Where
- 1 siteFinland
- Study dates
- Apr 2014to Jan 2016
- 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: 1342 patients with 1998 elective cardioversions
Who may be able to join
- All patients with persistent (>48h) atrial fibrillation and elective electrical cardioversion
Who cannot join
- Cardioversions for patients with acute (<48h) atrial fibrillation
- Pharmacological cardioversions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Finnish Elective Cardioversion for Persistent Atrial Fibrillation Study
This is a retrospective multi-center patient cohort study investigating patients with persistent atrial fibrillation (AF) and elective cardioversion (ECV). The aim is to identify clinical predictors for ineffective ECV to improve management quality of persistent AF.
Read the detailed description
Data was gathered from patient registries of two finnish university hospitals and two regional hospitals in a time period of 2003-2015. A data search was conducted using the ICD-10 code for atrial fibrillation and NCSP code for cardioversion. All patients with AF and performed cardioversion were eligible for the study.
Initially, 2373 patients were captured after which all ECV cases were identified and included manually in the study using a structured electronic case report form. The study cohort comprised 1998 ECVs and 1342 patients. Follow-up data was gathered for 30 days after ECV and all strokes, transient ischemic attacks, arrhythmic complications, AF recurrences and failed cardioversions were recorded and subjected to careful exploration. IBM SPSS Statistics software version 22.0 was used to perform all analyses.
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial Fibrillation, Cardioversion
- Medical subject headings
- Atrial Fibrillation
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatal or Non-fatal Stroke/TIA
Measured: 30 days
Secondary outcomes (3)
Arrhythmic Complications
bradyarrhythmias, ventricular tachycardia and ventricular fibrillation
Measured: 24 hours
Failure of Cardioversion
Assessed at discharge
Measured: 24 hours
Recurrence of AF after ECV
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2016 (estimated)
- Study startApr 2014
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,342 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turku
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juhani Airaksinen, University of Turku
- Investigators
- Juhani Airaksinen, Professor, Principal investigator, Turku University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02850679
- Sponsor's protocol ID
- T118/2014
- Acronym
- FinCV2
- Status last verified
- Jul 2016
- First submitted
- 26 Jul 2016
- Last updated
- 1 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Finnish Elective Cardioversion for Persistent Atrial Fibrillation Study
- ClinicalTrials.gov ID
- NCT02850679
- Acronym / sponsor ID
- FinCV2 / T118/2014
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial Fibrillation, Cardioversion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,342 participants (actual)
- Lead sponsor
- University of TurkuUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 1 Aug 2016 (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.
This is a retrospective multi-center patient cohort study investigating patients with persistent atrial fibrillation (AF) and elective cardioversion (ECV). The aim is to identify clinical predictors for ineffective ECV to improve management quality of persistent AF.
Detailed description
Data was gathered from patient registries of two finnish university hospitals and two regional hospitals in a time period of 2003-2015. A data search was conducted using the ICD-10 code for atrial fibrillation and NCSP code for cardioversion. All patients with AF and performed cardioversion were eligible for the study.
Initially, 2373 patients were captured after which all ECV cases were identified and included manually in the study using a structured electronic case report form. The study cohort comprised 1998 ECVs and 1342 patients. Follow-up data was gathered for 30 days after ECV and all strokes, transient ischemic attacks, arrhythmic complications, AF recurrences and failed cardioversions were recorded and subjected to careful exploration. IBM SPSS Statistics software version 22.0 was used to perform all analyses.
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
- 1342 patients with 1998 elective cardioversions
Key inclusion criteria (1 listed)
- All patients with persistent (>48h) atrial fibrillation and elective electrical cardioversion
Key exclusion criteria (2 listed)
- Cardioversions for patients with acute (<48h) atrial fibrillation
- Pharmacological cardioversions
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
Fatal or Non-fatal Stroke/TIA
Time frame: 30 days
3 secondary outcomes
Arrhythmic Complications
Time frame: 24 hours
Failure of Cardioversion
Time frame: 24 hours
Recurrence of AF after ECV
Time frame: 30 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 1 Aug 2016.
- Individual participant dataSharing planned: Undecided
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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.
Juhani Airaksinen, Professor principal investigator
Turku University Hospital
1 site 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 University of Turku at 1 site 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 2 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 1 Aug 2016. 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 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?
Fatal or Non-fatal Stroke/TIA (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Aug 2016; AzTrials last refreshed its copy on 29 Oct 2026.