Non-valvular AF
Conditions
Interventions
Group A:Biodegradable left atrial appendage occluder
Group B:Left atrial appendage occluder system
Sponsors
Hefei High-Tech Cardiovascular Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients with non-valvular AF aged 18-80 years (included); 2. Male CHA2DS2-VASc score >= 2 points, female >= 3 points; 3. At least one of the following situations exists: (1) Not suitable for long-term standardized anticoagulant therapy; (2) Stroke or embolism still occurs on the basis of long-term standardized anticoagulation therapy; (3) HAS-BLED score >= 3 points; (4) Not willing to undergo long-term anticoagulation therapy; 4. Volunteer to participate in the clinical trial, and sign the informed consent of the subjects.
Exclusion criteria
Exclusion criteria: 1. Patients with thrombus or suspected thrombus in the left atrium or left atrial appendage; 2. The anatomical structure of the left atrial appendage is not suitable for left atrial appendage occlusion (such as left atrial inner diameter > 65 mm); 3. Patients with left ventricular ejection fraction (LVEF) < 30%; 4. If there is pericardial effusion of more than 10mm in the base or posterior wall of the heart, and the cause is unknown; 5. Other diseases other than atrial fibrillation that require long-term anticoagulant treatment (such as spontaneous or recurrent venous thromboembolism after mechanical valve replacement); 6. Existence of rheumatic heart valve disease, mitral stenosis (valve area < 1.5 cm2), or after mechanical valve replacement surgery; 7. Patients with serious heart valve disease or cardiac structural abnormalities (such as huge atrial septal defect, interventricular septum defect) that need surgical treatment, or patients with severe coronary heart disease who need coronary artery bypass grafting; 8. Expected survival time < 1 year; 9. Uncontrolled heart failure with New York Heart Function Class IV; 10. Previous history of atrial septal repair surgery or implantation of atrial septal occluder; 11. Pregnant or lactating women and those who plan to conceive during the trial period; 12. Other situations that the researcher believes are not suitable for inclusion in this experiment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The success rate of occlusion 6 months after operation;Adverse events; | — |
Secondary
| Measure | Time frame |
|---|---|
| Device success;Surgical success;Ischemic stroke;systemic embolism;cardiovascular death; | — |
Countries
China
Contacts
Public ContactKejiang Cao
Hefei High-Tech Cardiovascular Hospital
Outcome results
None listed