Atrial fibrillation
Conditions
Interventions
PVI+LAAC:PVI+LAAC
PVI+NOAC:PVI+NOAC
Sponsors
Shanghai Chest Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Participants with paroxysmal / persistent / long-term persistent nonvalvular atrial fibrillation; 2. CHA2DS2-VASC score: male >= 2, female >= 3; 3. Age > 18 years old, 30ml / min ; 6. Those who can accept and tolerate short-term anticoagulant / antiplatelet therapy; 7. The participants or the legal agent is willing to sign the informed consent and participate the trial and agree to cooperate with clinical follow-up and examinations.
Exclusion criteria
Exclusion criteria: 1. Patients with left atrial or left atrial appendage thrombus or suspected thrombus detected by preoperative transesophageal echocardiography (TEE) or cardiac CT angiography (CCTA); 2. Preoperative TEE examination indicates complex anatomical structure of the left atrial appendage (e.g., excessively small or large ostium of the left atrial appendage, or complex anatomy with no suitable occluder option), making the patient unsuitable for left atrial appendage occlusion under current technical and equipment conditions; 3. Transthoracic echocardiography (TTE) examination indicates left ventricular ejection fraction (LVEF) = 30%; 4. TTE examination indicates pericardial effusion of more than 10 mm at the cardiac base or posterior wall with unknown cause; 5. Presence of other diseases (excluding atrial fibrillation) requiring long-term anticoagulant therapy (e.g., post-mechanical valve replacement, spontaneous or recurrent venous thromboembolism); 6. Presence of rheumatic heart valve disease, moderate to severe mitral stenosis (valve orifice area = 1.5 cm²), or post-mechanical valve replacement; 7. Presence of severe heart valve disease or cardiac structural abnormalities (e.g., large atrial septal defect, ventricular septal defect) requiring surgical treatment, or severe coronary heart disease requiring coronary artery bypass grafting; 8. New-onset ischemic stroke/transient ischemic attack (TIA) without hemorrhagic transformation, but unsuitable for initiating anticoagulant therapy as evaluated by the National Institutes of Health Stroke Scale (NIHSS) score and neurologists; 9. Acute ischemic stroke with hemorrhagic transformation or intracranial hemorrhage caused by oral anticoagulant therapy, and unsuitable for restarting anticoagulant therapy as evaluated by a multidisciplinary team; 10. Active peptic ulcer with bleeding within 3 months; 11. Patients with coagulation disorders or coagulation factor deficiency; 12. Expected survival time < 1 year; 13. Uncontrolled heart failure with New York Heart Association (NYHA) Functional Class IV.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The composite endpoint consisting of stroke/systemic thromboembolism, intracerebral hemorrhage, other major bleeding events (BARC Grade 2), cardiovascular death, and all-cause death.;7-day periprocedural complications; | — |
Secondary
| Measure | Time frame |
|---|---|
| Recurrence rate of atrial fibrillation;Rehospitalization related to atrial fibrillation; | — |
Countries
China
Contacts
Public ContactHe Ben
Shanghai Chest Hospital
Outcome results
None listed