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NCT Number: NCT06987825

Chinese Atrial Fibrillation Registry

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.

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Key information

Conditions

Atrial Fibrillation (AF) Arrhythmias, Cardiac Atrial Fibrillation 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

Beijing Anzhen Hospital, Beijing, Beijing Municipality, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. All-cause death

    Time frame: 10 years

    Death due to any cause.

Secondary outcomes

  1. Ischemic Stroke

    Time frame: 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.

  2. Hemorrhagic Stroke

    Time frame: 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.

  3. Transient ischemic attack (TIA)

    Time frame: 5 years

    A sudden onset of neurological deficit lasting less than 24 hours.

  4. Cardiovascular Death

    Time frame: 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.

  5. Cardiovascular Hospitalization

    Time frame: 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.

  6. Systemic Embolism

    Time frame: 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.

  7. Thromboembolic Death

    Time frame: 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.

  8. Major Bleeding

    Time frame: 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.

  9. Clinically Relevant Non-Major Bleeding (CRNMB)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Liu He, PhD

CONTACT

[email protected]

+86 13810720787

Sponsors and collaborators

Lead sponsor

Beijing Anzhen Hospital

Other

Registry information

Acronym: China-AF

Important dates

Study start
2011
Primary completion
2035
Study completion
2035
First posted
May 23, 2025
Registry last updated
May 23, 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.

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