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Enrolling by invitation NCT06802965

Shanghai Atrial Fibrillation Registry

Observational Atrial Fibrillation (AF)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: catheter ablation, left atrial appendage closure.
Who it may be relevant to
Registry conditions: Atrial Fibrillation (AF). Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

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.

Interventions

  • 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.

Primary outcome measures

  • Composite of death, ischemic stroke, systemic embolism, myocardial infarction, major bleeding, and acute heart failure [Time frame: From enrollment to December 31, 2024]
Secondary outcome measures (7)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Xinhua Hospital, School of Medicine, Shanghai Jiao Tong University — Shanghai

Identifiers

NCT: NCT06802965 · XHEC-C-2024-220-1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗