Shanghai Atrial Fibrillation Registry (SAFE)

January 26, 2025 updated by: Yiguang LI, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
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

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
400000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
From enrollment to December 31, 2024

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cardiovascular death
Time Frame: From enrollment to December 31, 2024
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
Time Frame: From enrollment to December 31, 2024
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
Time Frame: From enrollment to December 31, 2024
  • 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
Time Frame: From enrollment to December 31, 2024
  • 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
Time Frame: From enrollment to December 31, 2024
  • 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
Time Frame: From enrollment to December 31, 2024

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)
Time Frame: From enrollment to December 31, 2024
  • 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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Medical cost
Time Frame: From enrollment to December 31, 2024
Medical cost related to: AF and non-AF diseases; at emergency department, outpatient and inpatient.
From enrollment to December 31, 2024

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Shanghai Health Statistics Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 26, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 26, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 26, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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