Non-valvular atrial fibrillation
Conditions
Interventions
test group:Implantation of a Split Left Ear Blocker System
control group:Implantation of a Left Ear Blocker System
Sponsors
Zhongshan Hospital of Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. age 18 years and older; 2. patients with non-valvular atrial fibrillation with a CHA2DS2-VASc score of =2 who fulfill any of the following: a. Patients who, in the opinion of the investigator, are not suitable for long-term anticoagulation therapy or have poor compliance with long-term anticoagulation therapy; b, Stroke or embolic events despite long-term standardized anticoagulation therapy; c. patients at high risk of bleeding with a HAS-BLED score =3; 3. Subjects can understand the purpose of the trial, participate voluntarily and sign the informed consent form approved by the Ethics Committee in writing, and agree to complete the follow-up in accordance with the requirements of the program.
Exclusion criteria
Exclusion criteria: Clinical exclusion criteria: 1. the presence of diseases other than atrial fibrillation that require long-term anticoagulation therapy; 2. paroxysmal atrial fibrillation occurring with a clearly identifiable cause; 3. presence of an attached thrombus in the left atrium; 4. previous repair of atrial septal defect or implantation of atrial septal defect occluder; 5. previous repair of an atrial septal defect or implantation of an atrial septal defect occluder; 6. presence of a mechanical valve or peripheral vascular disease that interferes with placement of the test or control device; 7. atrial fibrillation due to rheumatic heart valve disease, degenerative heart valve disease, or congenital heart valve disease and valve disease such as mitral stenosis or aortic stenosis; 8. patients with a new stroke or TIA episode within 30 days prior to enrollment; 9. active infection; 10. acute myocardial infarction or severe coronary artery disease scheduled for CABG within 3 months prior to enrollment; 11. heart failure, NYHA classification IV; 12. renal insufficiency (Cr > 3.0mg/dl) or advanced renal disease requiring dialysis treatment; 13. active bleeding, or abnormal blood indicators: leukopenia WBC 10mm); 22. Preoperative TEE/CCTA examination reveals that the anatomical structure of the left auricle is unsuitable for implantation of the test or control device;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Freedom from ischemic stroke, TIA, and systemic embolism 12 months after surgery;Success rate of left auricular occlusion at 12 months postoperatively; | — |
Secondary
| Measure | Time frame |
|---|---|
| Prevalence of stroke (including ischemic, hemorrhagic, or undetermined), transient ischemic (TIA) episodes at 7 days, 1 month, 3 months, 6 months, and 12 months prior to discharge or postoperatively;Incidence of Ischemic Stroke, All-Cause Death, and Systemic Embolism Composite Endpoint Events at 7 Days, 1 Month, 3 Months, 6 Months, and 12 Months Prior to Discharge or Postoperatively;Device-related complications requiring treatment prior to discharge or at 7 days, 1 month, 3 months, 6 months, and 12 months postoperatively;Incidence of major bleeding events before discharge or at 7 days, 1 month, 3 months, 6 months and 12 months postoperatively;Instrument success rate;Technical success rate;Surgical time;parachute change rate; | — |
Countries
China
Contacts
Public ContactJunbo Ge
Zhongshan Hospital of Fudan University
Outcome results
None listed