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

Atrial Fibrillation Clinical Trial

— FinCV-4  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04001205
• Other study ID #: T75/2019
• Status: Active, not recruiting
• Start date: June 1, 2019
• Est. completion date: January 8, 2025

Study information

• Verified date: May 2024
• Source: University of Turku
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1300
• Est. completion date: January 8, 2025
• Est. primary completion date: January 8, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

• 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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Ischemic Stroke
• Stroke, Ischemic

Intervention

Drug:
• Anticoagulation Therapy
Long term oral anticoagulation with VKA (vitamin K antagonist) or NOAC (non-vitamin K oral anticoagulant)

Locations

Country	Name	City	State
Finland	Turku University Hospital, Heart Center	Turku	Varsinais-suomi

Sponsors (1)

Lead Sponsor	Collaborator
University of Turku

Country where clinical trial is conducted

Finland, 

References & Publications (1)

Airaksinen 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death	Death from any cause	From the first cardioversion through study completion, an average of 6 years
Primary	Ischemic stroke or TIA (transient ischemic attack)	Ischemic stroke or TIA diagnosed by neurologist	From the first cardioversion through study completion, an average of 6 years
Primary	Major Bleed	Major Bleeding complication according to ISTH (International Society on Thrombosis and Haemostasis)	From the first cardioversion through study completion, an average of 6 years
Secondary	Permanent oral anticoagulation	Initiation of permanent oral anticoagulation therapy, information on oral anticoaglation initiation done by reviewing electronic patient records	From the first cardioversion through study completion, an average of 6 years.