Chinese Atrial Fibrillation Registry

Recruiting

• Conditions: Atrial Fibrillation (AF)

• Registration Number: NCT06987825
• Lead Sponsor: Beijing Anzhen Hospital

Brief Summary

This prospective, observational cohort study aims to establish a long-term registry of adult patients with atrial fibrillation (AF) in China to comprehensively characterize patient profiles and evaluate real-world management and outcomes over time. The objectives of the study are to:

* Describe the demographic, clinical, and treatment characteristics of AF patients across different stages of disease progression.

* Assess the effectiveness and safety of various AF treatment strategies, including oral anticoagulation, catheter ablation, and left atrial appendage closure, in routine clinical practice.

* Identify patient- and treatment-related factors that influence therapeutic outcomes.

* Explore the role of advanced technologies and artificial intelligence in improving procedural performance, risk stratification, and clinical decision-making in AF care.

Participants will undergo standardized baseline evaluation and longitudinal follow-up to collect data on heart rhythm monitoring, treatment exposures, healthcare utilization, clinical events, and patient-reported outcomes. This cohort will generate real-world evidence to inform personalized and evidence-based management of AF.

Detailed Description

This prospective, multicenter observational registry aims to collect standardized clinical data on adults with atrial fibrillation (AF) across over 30 hospitals in China. The study reflects real-world clinical practice and does not interfere with treatment decisions.

Baseline and follow-up data will be collected using standardized forms, including demographics, medical history, cardiovascular risk factors, laboratory and imaging results, medication use, and-when applicable-procedural details for catheter ablation, such as energy source and complications.

Follow-up will be conducted at 1, 2, 3, and 6 months after enrollment, and every 6 months thereafter. Data include ECG monitoring, medication updates, hospitalizations, adverse events (e.g., stroke, bleeding, cardiovascular death), and healthcare utilization. Quality of life, cognitive, and psychological assessments may also be collected.

All treatments are determined by physicians as part of usual care. The registry provides internal feedback on potential treatment issues and generates periodic, anonymized summaries for participating centers.

The study aims to inform clinical practice and support real-world evidence generation to improve AF management in China.

Study Timeline

• Study Start: 2011-08-01
• Status Verified: 2025-05
• Study First Submitted: 2025-05-16
• Study First Submitted QC: 2025-05-16
• Last Update Submitted: 2025-05-16
• Study First Posted: 2025-05-23
• Last Update Posted: 2025-05-23
• Primary Completion: 2035-12-31
• Study Completion: 2035-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100000

Inclusion Criteria

1. Age ≥ 18 years;
2. Documented atrial fibrillation episode lasting >30 seconds confirmed by electrocardiogram (ECG), Holter monitor, implantable cardiac monitor, or wearable ECG device
3. Signed informed consent and willingness to participate in follow-up

Exclusion Criteria

1. Atrial fibrillation due to a reversible cause (e.g., transient secondary AF)
2. Presence of comorbid conditions associated with an expected life expectancy of less than 1 year

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
All-cause death	10 years	Death due to any cause.

Secondary Outcome Measures

Name	Time	Method
Thromboembolic Death	5 years	Death that occurs in the context of a confirmed or suspected thromboembolic event, such as ischemic stroke or systemic embolism, without an alternative non-cardiovascular cause.
Ischemic Stroke	5 years	An acute episode of neurological dysfunction caused by focal cerebral, spinal, or retinal infarction, confirmed by neuroimaging (CT or MRI) or clinical criteria consistent with permanent tissue injury.
Hemorrhagic Stroke	5 years	Bleeding within the brain parenchyma or into the subarachnoid space due to rupture of cerebral blood vessels. Subtypes include intracerebral hemorrhage and subarachnoid hemorrhage.
Transient ischemic attack (TIA)	5 years	A sudden onset of neurological deficit lasting less than 24 hours.
Cardiovascular Death	5 years	Death resulting from cardiovascular causes, including acute myocardial infarction, sudden cardiac death, heart failure, stroke, fatal bleeding, or complications related to cardiovascular interventions.
Cardiovascular Hospitalization	5 years	Unplanned hospital admission primarily due to cardiovascular causes, including acute coronary syndrome, heart failure exacerbation, arrhythmia, stroke, cardiovascular procedures, or thromboembolic or bleeding complications.
Systemic Embolism	5 years	An acute arterial occlusion outside the central nervous system, confirmed by imaging or surgery, with clinical evidence of embolic origin. Events limited to pulmonary embolism are excluded.
Major Bleeding	5 years	Defined according to the International Society on Thrombosis and Haemostasis (ISTH) as any of the following: (1)Fatal bleeding; (2) Symptomatic bleeding in a critical area or organ (e.g., intracranial, intraspinal, intraocular, pericardial, retroperitoneal); (3) A fall in hemoglobin of ≥2 g/dL (20 g/L), or leading to transfusion of ≥2 units of whole blood or red cells.
Clinically Relevant Non-Major Bleeding (CRNMB)	5 years	Any bleeding that does not meet the criteria for major bleeding but is associated with medical intervention, unscheduled physician contact, temporary interruption of treatment, or discomfort sufficient to interfere with daily activities.

Trial Locations

Locations (2)

Beijing Anzhen Hospital; 🇨🇳 Beijing, Beijing, China

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China