Prevention of stroke with atrial fibrillation
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Aged 18 to 85 years (not include 85 years old); 2.Patients with non valvular atrial fibrillation who meet the LAAC treatment indications (CHADS2 score >= 1 and are not suitable for long-term use of warfarin anticoagulants); 3.The expected service life shall not be less than 1 year; 4.Patients who can understand the purpose of this study, voluntarily participate in and sign informed consent, have good compliance after discharge and are willing to accept clinical follow-up; 5.Tolerance of materials or drugs related to this study.
Exclusion criteria
Exclusion criteria: 1.Thrombus or suspected thrombus in left atrium or left atrial appendage was detected by transesophageal echocardiography (TEE) or cardiac CT imaging (CCTA) before operation; 2.Left ventricular ejection fraction (LVEF) 200 µmol/L; 5.TTE examination showed that there was pericardial effusion more than 10 mm in the bottom or posterior wall of the heart; 6.Patients with severe heart valve disease or cardiac structural abnormalities (such as huge atrial septal defect and ventricular septal defect) requiring surgical treatment, or patients with severe coronary heart disease requiring coronary artery bypass grafting; 7.Active bleeding, severe abnormal coagulation function (1.5 times higher than the upper limit of normal value) or platelet count < 80 x 10^9/L; 8.Pregnant or lactating women; 9.Patients who participated in other clinical trials within 1 month before enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of major clinical events; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of bleeding events;Incidence of cardioascular death;Immediate surgical success rate;Incidence of device related complications;Incidence of all-cause deaths; | — |
Countries
China
Contacts
Zhongshan Hospital Affiliated to Fudan University