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Atrial Fibrillation Burden and Long-term Risk of Thromboembolic Complications- the FinCV-4 Study

Effect of Atrial Fibrillation Burden on Long-term Risk of Thromboembolic Complications- the FinCV-4 Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04001205
Acronym
FinCV-4
Enrollment
1300
Registered
2019-06-27
Start date
2019-06-01
Completion date
2025-01-08
Last updated
2024-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Stroke, Ischemic

Brief summary

This study explores the association of symptomatic episodes of atrial fibrillation (AF) occurrence and long-term risk of thromboembolic complications in a retrospective setting.

Detailed description

The study population consists of the FinCV-dataset, which includes 7660 acute cardioversions for atrial fibrillation. The electronic patient records of FinCV-study patients are reviewed to collect data on anticoagulation, number of cardioversions as well as mortality and stroke data. We seek to explore the possible association between the frequency of AF paroxysms in low stroke risk patients and the occurrence of death, stroke and major bleed as well as the net clinical benefit of anticoagulation. Data collection is performed by reviewing electronic patient records.

Interventions

Long term oral anticoagulation with VKA (vitamin K antagonist) or NOAC (non-vitamin K oral anticoagulant)

Sponsors

University of Turku
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* primary diagnosis of atrial fibrillation (ICD-10 code I48) * Cardioversion for acute (\<48 h) atrial fibrillation * \>18 years of age * living within the catchment area of the hospital

Design outcomes

Primary

MeasureTime frameDescription
DeathFrom the first cardioversion through study completion, an average of 6 yearsDeath from any cause
Ischemic stroke or TIA (transient ischemic attack)From the first cardioversion through study completion, an average of 6 yearsIschemic stroke or TIA diagnosed by neurologist
Major BleedFrom the first cardioversion through study completion, an average of 6 yearsMajor Bleeding complication according to ISTH (International Society on Thrombosis and Haemostasis)

Secondary

MeasureTime frameDescription
Permanent oral anticoagulationFrom the first cardioversion through study completion, an average of 6 years.Initiation of permanent oral anticoagulation therapy, information on oral anticoaglation initiation done by reviewing electronic patient records

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026