Shanghai Atrial Fibrillation Registry (SAFE)

Using the Shanghai Municipal Health Commission database and Shanghai Centers for Disease Control and Prevention database, patients with AF in Shanghai are included to construct the Shanghai AF registry to investigate clinical characteristics, treatment, and prognosis.

Study Overview

• Status: Enrolling by invitation
• Conditions: Atrial Fibrillation (AF)
• Intervention / Treatment: Procedure: catheter ablation, left atrial appendage closure

Detailed Description

1. To determine the most suitable risk stratification model for Chinese AF population regarding stroke and major cardiovascular events, i.e. CHA2DS2-VASc, CHA2DS2-VASc-60, or CHA2DS2-VA scores.
2. To compare the clinical prognosis of patients with AF receiving the combined procedure of catheter ablation and left atrial appendage closure (LAAC), single catheter ablation, and single LAAC.

• Study Type: Observational
• Enrollment (Estimated): 400000

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200092
    • Xinhua Hospital, School of Medicine, Shanghai Jiao Tong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population include patients with a diagnosis of AF in the Shanghai Municipal Health Commission database who are residence of Shanghai and with government-issued health insurance.

Description

Inclusion Criteria:

• With diagnosis of AF: the diagnosis must be identified from the Shanghai Municipal Health Commission database and verified by 12-lead ECG or Holter monitoring since 2015
• Residents of Shanghai
• Taking part in the government-issued health insurance, including the Urban Residents' Basic Medical Insurance (URBMI), the Urban-Employ Based Medical Insurance (UEBMI) and the New Rural Cooperative Medical Scheme (NRCMS).

Exclusion Criteria:

• Non-residence of Shanghai
• Without the government-issued health insurance
• Die at the day of index diagnosis of AF

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with AF; All patients with a diagnosis of AF and residents of Shanghai are included.	Procedure: catheter ablation, left atrial appendage closure; Compare the clinical prognosis of patients with AF underwent the combined procedure of catheter ablation and left atrial appendage closure (LAAC), single catheter ablation and single LAAC.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite of death, ischemic stroke, systemic embolism, myocardial infarction, major bleeding, and acute heart failure	Composite of death, ischemic stroke, systemic embolism, myocardial infarction, major bleeding, and acute heart failure	From enrollment to December 31, 2024

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiovascular death	Death due to the following reasons: Ischemic heart diseases; Hypertensive heart diseases; Other heart and vascular diseases, including myocarditis, endocarditis, pulmonary embolism, aortic aneurysm, dissecting aneurysm; Sudden, unexpected, and unwitnessed death or death of unknown cause; Ischemic stroke; Hemorrhagic stroke and non-traumatic intracranial bleeding	From enrollment to December 31, 2024
Non-cardiovascular death	Death caused by: Alzheimer's disease, Parkinson's disease, other neurological diseases except vascular central nervous system causes; Diabetes mellitus; Cancers (malignant solid tumors); Chronic obstructive pulmonary disease, lower respiratory infections, and other respiratory diseases; Gastrointestinal and liver diseases; Chronic kidney diseases and other kidney diseases; Leukemia, lymphoma, and other diseases of blood system; Falls; Road injuries; Drowning and asphyxia; Self-harm; COVID-19; Other non-cardiovascular causes of death, etc.	From enrollment to December 31, 2024
Ischemic stroke	Neurological deficit of cerebrovascular cause that persists beyond 24 hours or is interrupted by death within 24 hours.; Exclusion of coma due to severe brain trauma, intracranial tumor, metabolic disorder or fluid or electrolyte imbalance, peripheral neuropathy, or CNS infection.; Not meeting criteria for subarachnoid hemorrhage, intraparenchymal hemorrhage and other hemorrhage; With imaging findings	From enrollment to December 31, 2024
Systemic embolism	Acute vascular insufficiency or occlusion of the extremities or any non-CNS organ associated with clinical, imaging, surgical/autopsy evidence of arterial occlusion.; Exclusion of other likely mechanism, e.g., trauma, atherosclerosis, or instrumentation, etc.	From enrollment to December 31, 2024
Myocardial infarction	A rise of cardiac biomarker values (preferably cardiac troponin) with at least one value above the 99th percentile upper reference limit and with at least one of the following:; Symptoms of ischemia; ECG evidence: new ST-segment-T wave (ST-T) changes, or new left bundle branch block, or new pathological Q waves; Imaging evidence: new loss of viable myocardium or new regional wall motion abnormality; Angiography evidence: intracoronary thrombus	From enrollment to December 31, 2024
Major bleeding	At least one of the following conditions: Fatal bleeding; Symptomatic bleeding in a critical organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome; Bleeding causing a fall in hemoglobin level of 20 g/L or more or leading to transfusion of two or more units of whole blood or red cells.	From enrollment to December 31, 2024
Acute Heart failure (HF)	Hospitalization, or emergency department visit requiring treatment with infusion therapy, for a clinical syndrome that presents with multiple signs and symptoms consistent with cardiac decompensation or inadequate cardiac pump function.; Evidence in the doctor's notes that the reason for this hospitalization, or emergency department visit, was heart failure.; Evidence of signs and symptoms: increasing or new onset shortness of breath, edema, paroxysmal nocturnal dyspnea, orthopnea, and hypoxia; Include acute decompensated HF with preserved, mid-range, and reduced left ventricular ejection fraction.; If a patient was diagnosed and treated for HF in an outpatient setting without infusion therapy for decompensated HF, such condition was not considered an outcome.	From enrollment to December 31, 2024

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medical cost	Medical cost related to: AF and non-AF diseases; at emergency department, outpatient and inpatient.	From enrollment to December 31, 2024

Collaborators and Investigators

• Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Collaborators: Shanghai Health Statistics Center

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2030

Study Registration Dates

• First Submitted: January 26, 2025
• First Submitted That Met QC Criteria: January 26, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 26, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Chinese; atrial fibrillation; catheter ablation; risk score; left atrial appendage closure
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: XHEC-C-2024-220-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No