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.
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
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
- 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.
- 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.
- Conditions
- Atrial Fibrillation (AF)
- 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 group | Role | What they receive |
|---|---|---|
| Patients with AF | All 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.
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)
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
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
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
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
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
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
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.
- First posted31 Jan 2025
- Study start1 Jan 2025
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Health Statistics Center
- Responsible party
- Principal investigator, Yiguang LI, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
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
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shanghai Atrial Fibrillation Registry
- ClinicalTrials.gov ID
- NCT06802965
- Acronym / sponsor ID
- SAFE / XHEC-C-2024-220-1
- Conditions
- Atrial Fibrillation (AF)
- Keywords
- atrial fibrillation, left atrial appendage closure, catheter ablation, risk score, Chinese
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 400,000 participants (estimated)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Collaborators
- Shanghai Health Statistics Center
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jan 2030 (estimated)
- First posted
- 31 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- 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.
- 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 design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with AF | – | Procedure: catheter ablation, left atrial appendage closureAll patients with a diagnosis of AF and residents of Shanghai are included. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (3 listed)
- Non-residence of Shanghai
- Without the government-issued health insurance
- Die at the day of index diagnosis of AF
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| catheter ablation, left atrial appendage closureCompare 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. | Procedure or surgery | Patients with AF |
Primary outcome
Composite of death, ischemic stroke, systemic embolism, myocardial infarction, major bleeding, and acute heart failure
Time frame: From enrollment to December 31, 2024
Composite of death, ischemic stroke, systemic embolism, myocardial infarction, major bleeding, and acute heart failure
7 secondary outcomes
Cardiovascular death
Time frame: From enrollment to December 31, 2024
Non-cardiovascular death
Time frame: From enrollment to December 31, 2024
Ischemic stroke
Time frame: From enrollment to December 31, 2024
Systemic embolism
Time frame: From enrollment to December 31, 2024
Myocardial infarction
Time frame: From enrollment to December 31, 2024
Major bleeding
Time frame: From enrollment to December 31, 2024
Acute Heart failure (HF)
Time frame: From enrollment to December 31, 2024
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.