Skip to content

Atrial Fibrillation Data Linkage Non-Interventional Study

Temporal Changes in Clinical Characteristics and Functions, and Their Relationship With Outcomes of Atrial Fibrillation: a Retrospective Study Utilizing Data Linkage of a Single Center Patient Data and National Claims Database in Korea

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05810727
Enrollment
12556
Registered
2023-04-12
Start date
2025-08-21
Completion date
2025-10-23
Last updated
2025-11-20

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

Conditions

Atrial Fibrillation

Brief summary

The purpose of this study is to understand temporal changes in clinical features and functions, and the relationship with outcomes of atrial fibrillation (AF). AF is a problem with speed or pattern that the heart beats. It is the most common type of arrythmia. The study will use data linkage of a single center patient data and national claims database in Korea. This study does not include an actual patient enrollment process.

Interventions

None listed

Sponsors

Pfizer
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

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

Inclusion criteria

* Patients had incident AF diagnosis (International Classification of Diseases 10th Revision \[ICD-10\]; I48) in an inpatient or outpatient setting at SNUH between 1 Jan 2010 and 31 Dec 2020 * Patients aged 18 years or older on the index date

Exclusion criteria

* Medical claims indicating a diagnosis code indicative of rheumatic mitral valvular heart disease, mitral valve stenosis, or prosthetic heart valve during 12 months period prior to first AF diagnosis

Design outcomes

Primary

MeasureTime frameDescription
Event Rate of Stroke/Systemic embolism (SE)Up to 12 months after AF diagnosis or after the start date of relevant atrial fibrillation(AF) treatmentNational Health Insurance Service(NHIS) Claims with the following ICD-10 diagnosis codes as main or all sub-diagnoses whichever came first (i.e., the first occurred event will be used): 1. Ischemic stroke: G45.9, I63, I69.3 2. Hemorragic stroke: I60, I61, I62, I69.0, I69.1, I69.2 3. Systemic embolism: I74 * Hospitalization and computed tomography (CT) or magnetic resonance imaging (MRI) codes (brain CT or MRI for ischemic stroke and hemorrhagic stroke; any CT or MRI for systemic embolism) were also required for identification.
Event Rate of Major bleedingUp to 12 months after the AF diagnosis or after the start date of relevant AF treatmentBleeding requiring hospitalization will be identified using hospital claims which had a bleeding diagnosis code as the first occurred ICD-10 code and will be consisted of intracranial hemorrahge (ICH), gastrointestinal (GI) bleeding, and other bleeding. Main and all sub-diagnosis codes will be used. Particularly, hospitalization and brain CT or MRI codes (as described in variable 'stroke or SE') will be needed to identify ICH.
All-Cause Mortality RatesUp to 12 months after the AF diagnosis or after the start date of relevant AF treatmentDeath will be identified from mortality registration data of Statistics Korea linked to NHIS database

Countries

South Korea

Outcome results

None listed

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