Atrial Fibrillation Data Linkage Non-Interventional Study

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pfizer

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Event Rate of Stroke/Systemic embolism (SE)

Time frame: Up to 12 months after AF diagnosis or after the start date of relevant atrial fibrillation(AF) treatment
National 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):
- Ischemic stroke: G45.9, I63, I69.3
- Hemorragic stroke: I60, I61, I62, I69.0, I69.1, I69.2
- 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 bleeding

Time frame: Up to 12 months after the AF diagnosis or after the start date of relevant AF treatment

Bleeding 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 Rates

Time frame: Up to 12 months after the AF diagnosis or after the start date of relevant AF treatment

Death will be identified from mortality registration data of Statistics Korea linked to NHIS database

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: Apr 12, 2023
Registry last updated: Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed