atrial fibrillation
Conditions
Interventions
Left atrial appendage closure:Left atrial appendage closure
Sponsors
Affiliated Hospital of Guizhou Medical University
Eligibility
Sex/Gender
All
Age
35 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age 35-80 years old; 2. Patients with paroxysmal, persistent or permanent nonvalvular atrial fibrillation; 3. The subject himself or his guardian fully understands the nature and requirements of the study, agrees and signs the informed consent; 4. CHA2DS2-VASc score =2 for males and =3 for females (C: chronic heart failure/left ventricular dysfunction, 1 score; H: hypertension, 1 score; A: Age =75 years old, 2 points; D: Diabetes mellitus, 1 score; S: Previous history of stroke /TIA/ thromboembolism, 2 points; V: Vascular diseases, 1 score; A: Age 65-74 years old, 1 point; Sc: female, 1 point); 5. Oral anticoagulant therapy contraindicated or HAS-BLED score =3 points (1 point meeting any of the following criteria: H: uncontrolled hypertension (systolic blood pressure >160 MMHG); A: Abnormal liver function (cirrhosis or bilirubin >2 times normal, or AST/ALT/AP>3 times normal), or abnormal kidney function (dialysis, kidney transplantation, creatinine >200umol/L); S: History of stroke, including lacunar stroke; B: Bleeding history or bleeding tendency; L: Unstable INR values (less than 65 years old; D: Use of anti-platelet or non-steroidal anti-inflammatory drugs, excessive alcohol)
Exclusion criteria
Exclusion criteria: 1. Patients with diseases requiring long-term anticoagulant therapy other than atrial fibrillation, such as pulmonary embolism after artificial mechanical heart valve implantation; 2. Severe aortic, mitral and tricuspid valve stenosis or regurgitation caused by rheumatic heart disease, degenerative heart disease and congenital heart valve disease; 3. Severe cardiac structural abnormalities (such as large atrial septal defect, ventricular septal defect, etc.) require surgical treatment; 4. History of acute myocardial infarction or unstable angina pectoris within the last 3 months, recent (within 30 days before surgery) or planned (within 60 days after surgery) cardiac or non-cardiac intervention or surgical procedures (such as percutaneous coronary intervention, cataract surgery, etc., except catheter ablation for atrial fibrillation on the day of surgery); 5. Severe cardiac insufficiency, defined as left ventricular ejection fraction (LVEF) 65mm; 9. TTE suggested pericardial effusion > 10mm; 10. Symptomatic carotid artery disease (e.g., carotid stenosis >50%); 11. History of stroke or transient ischemic attack (TIA) within the last 30 days; 12. Active bleeding diseases, congenital coagulation disorders, active digestive tract ulcers; 13. Active infection, active endocarditis, or other infection that causes bacteremia or septicemia; 14. Heart tumors or other malignant tumors, life expectancy is not more than 1 year; 15. Allergic to aspirin, clopidogrel and other antiplatelet drugs, heparin and other anticoagulants, contrast agents and any part or material of instruments such as Nitinol; 16. Hematological abnormalities (defined as hemoglobin < 90g/L, platelet count < 50×109/L); 17. Subjects with liver disease associated with coagulation abnormalities and clinically relevant bleeding risk, including those with cirrhosis reaching Child Pugh grades B and C; 18. Severe renal insufficiency (defined as eGFR < 30ml/min/1.73m2); 19. Pregnant or lactating women, or subjects who plan to become pregnant during the trial; 20. Participating in clinical trials of other drugs or medical devices (other than registered studies); 21. Subjects judged by the investigator to be unsuitable for this clinical study.(YNMT)·
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of composite endpoints 7 days after surgery or before discharge (whichever occurs later), including all-cause death, ischemic stroke, systemic embolism, and instrumental or surgery-related events(YNMT)· ;No residual shunt or residual shunt < 5 mm when the left atrial appendage occluder is re-examined 12 months after surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of ischemic stroke and/or systemic embolism at 3, 6, and 12 months postoperatively; | — |
Countries
China
Contacts
Public ContactWei Zhou
Affiliated Hospital of Guizhou Medical University
Outcome results
None listed