Atrial FibrillationFinFib2NCT01990105
Treatment of Atrial Fibrillation in Finland
An observational study of Atrial Fibrillation, run by Finnish Cardiac Society at 5 sites in Finland.
Trial summary
FINFIB 2 is an observational investigator-driven study that seeks to examine current treatment practice for atrial fibrillation in Finland. The investigators hypothesis is that the treatment of atrial fibrillation has improved since the introduction of new antiarrhythmic drugs and anticoagulants. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 1,013 participants
- Where
- 5 sitesFinland
- Study dates
- Nov 2013to Apr 2014
- 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: The study data will be obtained in the form of a cross-section sampling over two weeks. All patients with ECG-diagnosed AF who attend emergency clinics for examination or treatment of arrhythmia or other cardiac diseases during the study period will be included. The estimated number of patients is about 1000.
Who may be able to join
- All adult patients with ECG-diagnosed AF who attend emergency clinics for examination or treatment of arrhythmia or other cardiac diseases during the study period will be included.
Who cannot join
- None
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Finland5 sites
Helsinki University Central Hospital
Helsinki
Kuopio University Hospital
Kuopio
Oulu University Hospital
Oulu
Tampere University Hospital
Tampere
Turku University Hospital
Turku
About this study
Official title: Treatment of Atrial Fibrillation in Finland - the FinFib 2 Study
FINFIB 2 is an observational investigator-driven study that seeks to examine current treatment practice for atrial fibrillation in Finland. The investigators hypothesis is that the treatment of atrial fibrillation has improved since the introduction of new antiarrhythmic drugs and anticoagulants.
Read the detailed description
FINFIB 2 is an observational investigator-driven study that seeks to examine current treatment practice for atrial fibrillation (AF) in Finland. It will produce important information such as whether the introduction of the new agents has taken place in accordance with the treatment guidelines in different parts of Finland.
Working hypothesis is that the treatment of AF has improved since the introduction of new antiarrhythmic drugs and anticoagulants. However, the investigators also expect to find out that there are geographical differences in the use of these agents. The expect outcome is that the investigators will identify these differences and be able to better homogenize the treatment of AF in different parts of the country and different levels of the health care system.
The study data will be obtained in the form of a cross-section sampling over two weeks. All patients with ECG-diagnosed AF who attend emergency clinics for examination or treatment of arrhythmia or other cardiac diseases during the study period will be included. The investigators estimate the number of patients will be about 1000. Aside from background information, risk data (e.g. CHA2DS2VASc), symptoms (EHRA classification), medication, examinations and the choice of treatment, the only data recorded about each patient with AF will be date of birth and gender. The patients will be divided into four groups according to type of AF: 1. New onset AF, 2. Paroxysmal AF, 3. Persistent AF, 4. Permanent AF. The data will be obtained by the local study doctor using online, protected data collection program. The data will be stored on a secured server, which can be accessed for data entry by the investigators at the study centers. The database is not a personal data register, as identity codes will not be stored at any point and individual patients cannot be identified later through the database. Only the investigator group will have the rights to use the database.
- Conditions
- Atrial Fibrillation
- Keywords
- atrial fibrillation, anticoagulation, antiarrhythmic medication, CHA2DS2VASc score, HAS-BLED score, CHADS2 score
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with AF in the ER | All patients with ECG-diagnosed AF who attend emergency clinics for examination or treatment of arrhythmia or other cardiac diseases during the study period will be included. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to current atrial fibrillation treatment guidelines
All patients with ECG-diagnosed AF who attend emergency clinics for examination or treatment of arrhythmia or other cardiac diseases during the study period will be included for assessment of the adherence of their treatment to current guidelines.
Measured: Data collected during the ER visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionNov 2013
- Study completionApr 2014
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,013 participants (actual)
Sponsor and investigators
- Lead sponsor
- Finnish Cardiac Society
- Sponsor type
- University, hospital or other
- Collaborators
- Helsinki University Central Hospital, Kuopio University Hospital, Oulu University Hospital, Tampere University Hospital, Turku University Hospital
- Responsible party
- Sponsor
- Investigators
- Pekka Raatikainen, MD, PhD, Study chair, Heart Center Tampere Univerisity HospitalJuha Hartikainen, MD, Principal investigator, Kuopio University HospitalTimo Lauri, MD, Principal investigator, Oulu University HospitalMika Lehto, MD, Principal investigator, Helsinki University Central HospitalMarkku Mäkijärvi, MD, Principal investigator, Helsinki University Central HospitalJuha Lund, MD, Principal investigator, Turku University HospitalHeikki Mäkynen, MD, Principal investigator, Heart Center Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01990105
- Sponsor's protocol ID
- FCS-2013-1
- Other IDs
- R13044
- Acronym
- FinFib2
- Status last verified
- Mar 2015
- First submitted
- 15 Nov 2013
- Last updated
- 9 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Penttila T, Makynen H, Hartikainen J, Hyppola H, Lauri T, Lehto M, Lund J, Raatikainen MJP; FinFib2 investigators. Antiarrhythmic drug therapy among patients presenting to emergency department with symptomatic atrial fibrillation - a prospective nationwide cohort. Scand J Trauma Resusc Emerg Med. 2017 Aug 15;25(1):81. doi: 10.1186/s13049-017-0424-7.
PubMed 28810904
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Atrial Fibrillation in Finland - the FinFib 2 Study
- ClinicalTrials.gov ID
- NCT01990105
- Acronym / sponsor ID
- FinFib2 / FCS-2013-1
- Conditions
- Atrial Fibrillation
- Keywords
- atrial fibrillation, anticoagulation, antiarrhythmic medication, CHA2DS2VASc score, HAS-BLED score, CHADS2 score
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,013 participants (actual)
- Lead sponsor
- Finnish Cardiac SocietyUniversity, hospital or other
- Collaborators
- Helsinki University Central Hospital, Kuopio University Hospital, Oulu University Hospital, Tampere University Hospital, Turku University Hospital
- Study start
- Nov 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 21 Nov 2013 (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.
FINFIB 2 is an observational investigator-driven study that seeks to examine current treatment practice for atrial fibrillation in Finland. The investigators hypothesis is that the treatment of atrial fibrillation has improved since the introduction of new antiarrhythmic drugs and anticoagulants.
Detailed description
FINFIB 2 is an observational investigator-driven study that seeks to examine current treatment practice for atrial fibrillation (AF) in Finland. It will produce important information such as whether the introduction of the new agents has taken place in accordance with the treatment guidelines in different parts of Finland.
Working hypothesis is that the treatment of AF has improved since the introduction of new antiarrhythmic drugs and anticoagulants. However, the investigators also expect to find out that there are geographical differences in the use of these agents. The expect outcome is that the investigators will identify these differences and be able to better homogenize the treatment of AF in different parts of the country and different levels of the health care system.
The study data will be obtained in the form of a cross-section sampling over two weeks. All patients with ECG-diagnosed AF who attend emergency clinics for examination or treatment of arrhythmia or other cardiac diseases during the study period will be included. The investigators estimate the number of patients will be about 1000. Aside from background information, risk data (e.g. CHA2DS2VASc), symptoms (EHRA classification), medication, examinations and the choice of treatment, the only data recorded about each patient with AF will be date of birth and gender. The patients will be divided into four groups according to type of AF: 1. New onset AF, 2. Paroxysmal AF, 3. Persistent AF, 4. Permanent AF. The data will be obtained by the local study doctor using online, protected data collection program. The data will be stored on a secured server, which can be accessed for data entry by the investigators at the study centers. The database is not a personal data register, as identity codes will not be stored at any point and individual patients cannot be identified later through the database. Only the investigator group will have the rights to use the database.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with AF in the ER | – | –All patients with ECG-diagnosed AF who attend emergency clinics for examination or treatment of arrhythmia or other cardiac diseases during the study period will be included. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study data will be obtained in the form of a cross-section sampling over two weeks. All patients with ECG-diagnosed AF who attend emergency clinics for examination or treatment of arrhythmia or other cardiac diseases during the study period will be included. The estimated number of patients is about 1000.
Key inclusion criteria (1 listed)
- All adult patients with ECG-diagnosed AF who attend emergency clinics for examination or treatment of arrhythmia or other cardiac diseases during the study period will be included.
Key exclusion criteria (1 listed)
- None
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
Adherence to current atrial fibrillation treatment guidelines
Time frame: Data collected during the ER visit
All patients with ECG-diagnosed AF who attend emergency clinics for examination or treatment of arrhythmia or other cardiac diseases during the study period will be included for assessment of the adherence of their treatment to current guidelines.
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 9 Mar 2015.
- Derived from this study: PubMed 28810904Penttila T, Makynen H, Hartikainen J, Hyppola H, Lauri T, Lehto M, Lund J, Raatikainen MJP; FinFib2 investigators. Antiarrhythmic drug therapy among patients presenting to emergency department with symptomatic atrial fibrillation - a prospective nationwide cohort. Scand J Trauma Resusc Emerg Med. 2017 Aug 15;25(1):81. doi: 10.1186/s13049-017-0424-7.
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
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.
Pekka Raatikainen, MD, PhD study chair
Heart Center Tampere Univerisity Hospital
Juha Hartikainen, MD principal investigator
Kuopio University Hospital
Timo Lauri, MD principal investigator
Oulu University Hospital
5 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 Finnish Cardiac Society at 5 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 9 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
Adherence to current atrial fibrillation treatment guidelines (time frame: Data collected during the ER visit). 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 NCT01990105, 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 9 Mar 2015.