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Atrial Fibrillation (AF)SAFENCT06802965

Shanghai Atrial Fibrillation Registry

An observational study of Atrial Fibrillation (AF), run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Atrial Fibrillation (AF)
What is being tested?
catheter ablation, left atrial appendage closure
Type of treatment
Surgery or procedure
How many people
400,000 participants
Where
1 siteChina
Study dates
1 Jan 2025to 1 Jan 2030
How long will I take part?
3 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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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.

Who may be able to join

  • 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).

Who cannot join

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

Trial locations and contacts

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

China1 site
  • Xinhua Hospital, School of Medicine, Shanghai Jiao Tong University

    Shanghai, 200092

Other trials in China

About this study

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.

Read the 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.
Being tested
catheter ablation, left atrial appendage closure
Keywords
atrial fibrillation, left atrial appendage closure, catheter ablation, risk score, Chinese
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • catheter ablation, left atrial appendage closureProcedure or surgery

    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.

Study groups in NCT06802965
Study groupRoleWhat they receive
Patients with AFAll patients with a diagnosis of AF and residents of Shanghai are included.
Receives: Procedure: catheter ablation, left atrial appendage closure

What is being measured

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

  1. 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

    Measured: From enrollment to December 31, 2024

Secondary outcomes (7)
  1. 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

    Measured: From enrollment to December 31, 2024

  2. 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.

    Measured: From enrollment to December 31, 2024

  3. 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

    Measured: From enrollment to December 31, 2024

  4. 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.

    Measured: From enrollment to December 31, 2024

  5. 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

    Measured: From enrollment to December 31, 2024

  6. 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.

    Measured: From enrollment to December 31, 2024

  7. 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.

    Measured: From enrollment to December 31, 2024

Timeline

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

  1. First posted31 Jan 2025
  2. Study start1 Jan 2025
  3. Primary completion1 Jan 2028 (estimated)
  4. Study completion1 Jan 2030 (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
Other
Enrolment
400,000 participants (estimated)
Target duration
3 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT06802965
Sponsor's protocol ID
XHEC-C-2024-220-1
Acronym
SAFE
Status last verified
Jan 2025
First submitted
26 Jan 2025
Last updated
31 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Atrial Fibrillation (AF), run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site 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 3 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: enrolling by invitation, as of the sponsor's last update on 31 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite of death, ischemic stroke, systemic embolism, myocardial infarction, major bleeding, and acute heart failure (time frame: From enrollment to December 31, 2024). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 31 Jan 2025.

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