Non-valvular atrial fibrillation
Conditions
Interventions
Case series:LaagerTM device system
Sponsors
General Hospital of Northern Theater Command
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 80 years patient with non-valvular atrial fibrillation; 2. CHA2DS2-VASC score >=2; 3. One of the following conditions is not suitable for long-term use of anticoagulants: (1) Recorded history of bleeding (gastrointestinal tract, cerebrovascular, etc.) or bleeding tendency; (2) Warfarin anticoagulant drug allergy; (3) The long-term use of warfarin anticoagulant medication adherence is poor; (4) Standardize the warfarin anticoagulant therapy, stroke or embolism events; (5) HAS-BLED score>=3; 4. Participants or their legal representatives to understand the test purpose, is willing to cooperate with the surgical treatment and follow-up, volunteered for the experiment and signed a written informed consent.
Exclusion criteria
Exclusion criteria: 1. Rheumatic heart valve disease, degenerative heart valve disease, or congenital heart valve disease and severe mitral stenosis, aortic stenosis valvular diseases such as atrial fibrillation; 2. The incipient atrial fibrillation, atrial fibrillation occurred with clear reason of paroxysmal atrial fibrillation; 3. left the room mural thrombus formation; 4. Three months history of st-elevation acute myocardial infarction; 5. Cardiac function level IV (NYHA classification); 6. Severe renal insufficiency (serum creatinine > 450 umol/L) need kidney dialysis or kidney disease; 7. The history of surgical repair of atrial septum or interatrial septum closure implants; 8. Once done heart valve replacement or repair; 9. The nickel titanium alloy, aspirin, clopidogrel, heparin allergy or taboo; 10. In pregnancy, lactation, or the next year have family planning male or female; 11. Participate in other drugs or medical devices clinical trials have not yet completed; 12. The left auricle closure contraindications or researchers think doesn't fit to participate in the test; 13. Echocardiography and left open for measuring the intraoperative angiography of 35 mm; 14. Intraoperative angiography found the thrombus of left atrium is clear; 15. High risk of patent foramen ovale (> 4 mm); 16. There is a clear mitral stenosis (aortic area 2 cm2) or less; 17. There are obvious pericardial effusion (> 4 mm); 18. Left ventricular ejection fraction (LVEF) < 30%.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Closure rate of left atrial appendage in 12 months after operation;Ischemic stroke rate within 12 months after operation; | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. 7 days after operation or discharged, 1, 3, 6, 12 months, 2-5 years equipment failure of composite end point: including source of ischemic stroke and systemic embolism and death;Complications;Incidence of composite events of the device;Performance of device; | — |
Countries
China
Contacts
Public ContactYaling Han
General Hospital of Northern Theater Command
Outcome results
None listed