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Atrial Fibrillation (AF)China-AFNCT06987825

Chinese Atrial Fibrillation Registry

An observational study of Atrial Fibrillation (AF), run by Beijing Anzhen Hospital at 2 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atrial Fibrillation (AF)
How many people
100,000 participants
Where
2 sitesChina
Study dates
1 Aug 2011to 31 Dec 2035
How long will I take part?
10 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Adults (≥18 years) with documented atrial fibrillation enrolled from multiple hospitals across China.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Liu He, PhD contact

+86 13810720787

theliu@139.com

China2 sites, 2 recruiting

  • Beijing Anzhen Hospital

    Beijing, Beijing Municipality, 100029

    Liu He, PhD, +86 13810720787, theliu@139.com

    Recruiting

  • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310009

    Chenyang Jiang, +86 13857190051, jiangchenyangmail@163.com

    Recruiting

Other trials in China

About this study

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.

Read the 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.

Medical subject headings
Atrial Fibrillation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All-cause death

    Death due to any cause.

    Measured: 10 years

Secondary outcomes (9)

  1. Ischemic Stroke

    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.

    Measured: 5 years

  2. Hemorrhagic Stroke

    Bleeding within the brain parenchyma or into the subarachnoid space due to rupture of cerebral blood vessels. Subtypes include intracerebral hemorrhage and subarachnoid hemorrhage.

    Measured: 5 years

  3. Transient ischemic attack (TIA)

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

    Measured: 5 years

  4. Cardiovascular Death

    Death resulting from cardiovascular causes, including acute myocardial infarction, sudden cardiac death, heart failure, stroke, fatal bleeding, or complications related to cardiovascular interventions.

    Measured: 5 years

  5. Cardiovascular Hospitalization

    Unplanned hospital admission primarily due to cardiovascular causes, including acute coronary syndrome, heart failure exacerbation, arrhythmia, stroke, cardiovascular procedures, or thromboembolic or bleeding complications.

    Measured: 5 years

  6. Systemic Embolism

    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.

    Measured: 5 years

  7. Thromboembolic Death

    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.

    Measured: 5 years

  8. Major Bleeding

    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.

    Measured: 5 years

  9. Clinically Relevant Non-Major Bleeding (CRNMB)

    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.

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 May 2025
  2. Study start1 Aug 2011
  3. Primary completion31 Dec 2035 (estimated)
  4. Study completion31 Dec 2035 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
100,000 participants (estimated)
Target duration
10 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT06987825
Sponsor's protocol ID
KS2025087
Acronym
China-AF
Status last verified
May 2025
First submitted
16 May 2025
Last updated
23 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Dong H, Ying Q, Zhou L, He L, Jiang C, Long D, Ma C. Association Between Baseline Cognitive Impairment and Atrial Fibrillation Recurrence After Catheter Ablation. Pacing Clin Electrophysiol. 2026 Oct 12. doi: 10.1111/pace.70453. Online ahead of print.

    PubMed 42864730

  • Ren L, Peng X, Li S, Wang J, Zhang J, Lai Y, Xia S, Li J, Wang Z, Hu G, Li Q, Zhou L, Zhao Z, Yang Z, Li M, Liu X, Guo X, Zuo S, Li S, Zhou N, Tang R, Long D, He L, Du X, Dong J, Sang C, Ma C. Thromboembolism and Bleeding Risks in Atrial Fibrillation: Outcomes of Oral Anticoagulation After Catheter Ablation. J Am Heart Assoc. 2026 Aug 30:e047527. doi: 10.1161/JAHA.125.047527. Online ahead of print.

    PubMed 42669879

  • Ren L, Peng X, Li M, He L, Zhou N, Liu X, Zuo S, Dong J, Ma C, Guo X. Association of left ventricular geometry with outcomes and treatment response in atrial fibrillation and heart failure with preserved ejection fraction. Front Med (Lausanne). 2026 May 4;13:1824509. doi: 10.3389/fmed.2026.1824509. eCollection 2026.

    PubMed 42158122

  • Peng X, Li Q, Liu X, He L, Liu N, Yuan C, Li J, Zhao Z, Li M, Zuo S, Guo X, Zhao X, Zhou N, Sang C, Du X, Dong J, Ma C. Asymptomatic atrial fibrillation: Clinical characteristics, outcomes, and prognostic impact of rhythm control. Heart Rhythm. 2026 Jul;23(7):1483-1495. doi: 10.1016/j.hrthm.2025.10.012. Epub 2025 Oct 10.

    PubMed 41077365

Questions about this trial

What is this clinical trial studying?

An observational study of Atrial Fibrillation (AF), run by Beijing Anzhen Hospital at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Liu He, PhD (+86 13810720787, theliu@139.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All-cause death (time frame: 10 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06987825, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2025; AzTrials last refreshed its copy on 2 Nov 2026.

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