Study of Safety and Efficacy of a Left Atrial Appendage Occulder

Not yet recruiting

Phase 1/2 Results N/A

Eligibility Criteria

Inclusion Criteria

- Patient is ≥18 years of age;
- Chronic atrial fibrillation ≥3 months; paroxysmal, persistent or permanent non-valvular AF;
- CHADS2-VAS score 2 or higher,HAS-BLED score 3 or higher;
- Patient can understand the trial purpose, voluntarily join this clinical trial with informed consent;
- Patient voluntarily completes the follow-up and follow-up inspection in accordance with the clinical trials process.

Exclusion Criteria

1. A. Clinical exclusion criteria: Presence of rheumatic, degenerative or congenital valvular heart diseases, The diameter of left atrial ≥65 mm; LAA size < 12mm or > 30 mm Left atrium has been removed; Heart transplantation patients; Symptomatic patients with carotid artery disease (such as carotid stenosis ≥ 50%); Acute myocardial infarction or unstable angina; Decompensated heart failure (New York Heart Association functional class III-IV); Recent myocardial infarction (< 3 months); Patients with an atrial septal defect or received an atrial septal occluder. The patient has an ablation procedure planned within 30 days of potential LAmbre Occluder implant The patient has a planned cardioversion 30 days post implant of the LAmbre Occluder Patient who after artificial mechanical heart valve replacement operation; Uncontrolled Heart rate ≥ 110 beats / min17) History stroke or TIA within 30 days; Presence of complex aortic plaque(4mm) in ascending aorta; Cardiac tumors or other malignancy with estimated life expectancy u less than 2 years; Have thrombocytopenia (platelet 《105 / μl) or anemia(Hb<10g/dl); Women who is pregnancy or plan to pregnancy during the trial period; Presence of active sepsis or endocarditis; Patient participated in the other trials; The investigators expect the patient not be able to complete the trial according to requirements.
2. Esophageal ultrasonic exclusion criteria: LVEF≤30%; Presence of left atrial appendage thrombus; High risk PFO patients(presence of atrial septal aneurysm); Have obvious mitral valve stenosis (the area of mitral valve≤ 2 cm2); Have obvious and unexplained pericardial effusion(≥4 cm2). Presence of complex aortic plague(≥4 mm) in ascending aorta.