Non-valvular atrial fibrillation
Conditions
Interventions
Case series:Implantable the left atrial appendage closure device
Sponsors
Shanghai Chest Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: All selected subjects must meet all of the following criteria: 1. Aged 18 to 80 years patient with non-valvular atrial fibrillation (excluding rheumatic mitral valve disease) , a CHA2DS2-VASC score >=2; However, one of the following conditions is not suitable for long-term use of anticoagulants: (1) A documented history of bleeding (gastrointestinal bleeding, cerebral hemorrhage, etc.) or a high risk of bleeding (HAS-BLED score>=3); (2) poor adherence to or intolerance to Warfarin or other anticoagulants; 2. After short-term oral administration of Warfarin and aspirin + clopidogrel; 3. Subjects or their legal representatives were informed of the nature of the study and consented to participate in all the terms of the study, signed an informed consent letter approved by the Ethics Committee, consented to the post-operative treatment protocol and the follow-up required to complete the follow-up and follow-up required to complete the examination.
Exclusion criteria
Exclusion criteria: 1. Other diseases other than atrial fibrillation (such as repeated pulmonary embolism or deep vein thrombosis at other sites) that require long-term use of anticoagulant drugs such as warfarin; 2. Mitral stenosis (orifice area 50%); 7. Recent myocardial infarction 3.0mg/dl, 1mg/dl=88.4umol/L) and/or advanced renal disease require renal dialysis. Related to equipment: The left atrial appendage has been removed or has been plugged; Patients who have received atrial septal repair or atrial septal occluder implantation after heart transplantation Radiofrequency ablation should be avoided within 30 days after implantation of the left atrial appendage occluder (radiofrequency ablation may increase occluder displacement or increase device surface thrombosis); Patients should avoid electrical cardioversion within 30 days after implantation of left atrial appendage occluder (electrical cardioversion may increase occluder displacement or increase device surface thrombosis); Mechanical heart valve replacement surgery; Allergy to Nitinol, aspirin, clopidogrel, heparin or contraindicated; Other cardiac or non-cardiac interventions or surgical procedures are scheduled within 30 days after the plugging device implantation; Others: Pregnancy or planned pregnancy during the course of this study; Participate in clinical trials of other drugs or medical devices within 30 days prior to screening; The investigators determined that the patients had poor compliance and were unable to complete the study as required. 2. Exclusion criteria for transthoracic and transesophageal ultrasound: Esophageal echocardiography was used to measure the opening diameter of the left auricle (The diameter 32mm); LVEF =4mm).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ischemic stroke rate within 12 months after operation (event / patient year);Closure rate of left atrial appendage (event / number of patients receiving occluder implantation) immediately, 2 months and 6 months after operation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of perioperative complications within 7 days after operation;Perioperative complications before discharge;Incidence of composite events 12 months after operation;Occluder performance; | — |
Countries
China
Contacts
Public ContactHe Ben
Shanghai Chest Hospital
Outcome results
None listed