Clinical trial NCT06987825: Chinese Atrial Fibrillation Registry
Official title: Chinese Atrial Fibrillation Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atrial Fibrillation (AF)
Lead sponsor: Beijing Anzhen Hospital
Sponsor class: OTHER
First posted: 2025-05-23
Enrollment: 100000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults (≥18 years) with documented atrial fibrillation enrolled from multiple hospitals across China.

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.

Eligibility criteria: 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

Primary outcomes:
measure: All-cause death
timeFrame: 10 years
Secondary outcomes:
measure: Ischemic Stroke
timeFrame: 5 years
measure: Hemorrhagic Stroke
timeFrame: 5 years
measure: Transient ischemic attack (TIA)
timeFrame: 5 years
measure: Cardiovascular Death
timeFrame: 5 years
measure: Cardiovascular Hospitalization
timeFrame: 5 years
measure: Systemic Embolism
timeFrame: 5 years
measure: Thromboembolic Death
timeFrame: 5 years
measure: Major Bleeding
timeFrame: 5 years
measure: Clinically Relevant Non-Major Bleeding (CRNMB)
timeFrame: 5 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital
state: Beijing
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: Beijing Anzhen Hospital
name: Changsheng Ma, MD
role: PRINCIPAL_INVESTIGATOR
References: