Atrial FibrillationFinCV3NCT02911545
Non-vitamin K Oral Anticoagulants in Cardioversion
An observational study of Atrial Fibrillation, run by Helsinki University Central Hospital.
Trial summary
Non-vitamin K oral anticoagulants (NOAC) have been shown to be safe and effective alternatives to warfarin for stroke prevention in patients with nonvalvular AF (NVAF). There are yet limited real life data on outcomes following elective cardioversion in AF patients treated with NOACs. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- Oct 2011to May 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: AF patients undergoing cardioversion.
Who may be able to join
- AF patients undergoing cardioversion
Who cannot join
- -
About this study
Official title: Non-vitamin K Oral Anticoagulants in Cardioversion of Atrial Fibrillation. FinCV3
Non-vitamin K oral anticoagulants (NOAC) have been shown to be safe and effective alternatives to warfarin for stroke prevention in patients with nonvalvular AF (NVAF). There are yet limited real life data on outcomes following elective cardioversion in AF patients treated with NOACs. The aim of this study is to investigate the complications and the use of NOACs in AF patients undergoing cardioversion.
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial fibrillation, Anticoagulation, Cardioversion
- Medical subject headings
- Atrial Fibrillation
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and predictors of thromboembolic complications
Measured: 31 days after cardioversion of persistent AF
Incidence and predictors of bleeding
Measured: 31 days after cardioversion of persistent AF
Secondary outcomes (2)
Number of recurrence of AF
Measured: 31 days after cardioversion of persistent AF
Hemodynamic complications of cardioversion
Measured: 31 days after cardioversion of persistent AF
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2016 (estimated)
- Study startOct 2011
- Primary completionDec 2015
- Study completionMay 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.
- More trials run by Helsinki University Central 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
- Prospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Turku
- Responsible party
- Principal investigator, Mika Lehto, Helsinki University Central Hospital
- Investigators
- Mika Lehto, MD, PhD, Principal investigator, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02911545
- Sponsor's protocol ID
- FinCV3
- Acronym
- FinCV3
- Status last verified
- Sep 2016
- First submitted
- 16 Sep 2016
- Last updated
- 22 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-vitamin K Oral Anticoagulants in Cardioversion of Atrial Fibrillation. FinCV3
- ClinicalTrials.gov ID
- NCT02911545
- Acronym / sponsor ID
- FinCV3 / FinCV3
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial fibrillation, Anticoagulation, Cardioversion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Collaborators
- University of Turku
- Study start
- Oct 2011
- Primary completion
- Dec 2015 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 22 Sep 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.
Non-vitamin K oral anticoagulants (NOAC) have been shown to be safe and effective alternatives to warfarin for stroke prevention in patients with nonvalvular AF (NVAF). There are yet limited real life data on outcomes following elective cardioversion in AF patients treated with NOACs. The aim of this study is to investigate the complications and the use of NOACs in AF patients undergoing cardioversion.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- AF patients undergoing cardioversion.
Key inclusion criteria (1 listed)
- AF patients undergoing cardioversion
Key exclusion criteria (1 listed)
- -
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
Time frame: 31 days after cardioversion of persistent AF
Incidence and predictors of bleeding
Time frame: 31 days after cardioversion of persistent AF
2 secondary outcomes
Number of recurrence of AF
Time frame: 31 days after cardioversion of persistent AF
Hemodynamic complications of cardioversion
Time frame: 31 days after cardioversion of persistent AF
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 22 Sep 2016.
- Individual participant dataSharing planned: No
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Paroxysmal AF
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Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
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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.
Mika Lehto, MD, PhD principal investigator
Helsinki University Central Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Helsinki University Central Hospital.
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 22 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
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 (time frame: 31 days after cardioversion of persistent AF). The study lists 2 primary outcomes in all. 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 22 Sep 2016.