atrial fibrillation
Conditions
Interventions
Watchman FLX LAAC group:WATCHMAN FLX LAAC procedure
Sponsors
Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: (1) age is between 18 and 85; (2) patients with nonvalvular atrial fibrillation; (3) CHA2DS2-VASc score =2; (4) HAS-BLED score =3 or unwilling to take long-term oral anticoagulants; (5) patients with AF who successfully completed the WATCHMAN FLX LAAC procedure (no new pericardial effusion, tamponade, device migration during the procedure, and no new pericardial effusion affecting hemodynamics by echocardiography after the procedure); (6) able to understand the purpose of the study, voluntarily participate and sign informed consent, and willing to be followed up.
Exclusion criteria
Exclusion criteria: (1) mechanical prosthesis, evidence of thrombosis, complex atherosclerosis, or symptomatic carotid artery disease (e.g., after mechanical valve replacement; Bioprosthetic valve replacement or mitral valve repair within 3 months; Spontaneous or recurrent venous thromboembolism; Complex multivessel coronary artery disease or symptomatic carotid artery stenosis (transient ischemic attack, ischemic stroke) requiring long-term antiplatelet therapy); (2) contraindications to TEE examination; (3) platelet count < 60×10^9/L; (4) left ventricular ejection fraction (LVEF) < 35%; (5) Liver cirrhosis patients with severe renal failure, eGFR < 30 ml/min/1.73 m2 or Child Pugh B or C; (6) contraindications to any form of anticoagulant or antiplatelet therapy or drug allergy; (7) no residual shunt =3mm immediately after occlusion; (8) patients with acute coronary syndrome; (9) lesions or conditions that are at significant risk for major bleeding, such as current or recent gastrointestinal ulcers, presence of malignancy with a high risk of bleeding, recent brain or spinal injury, recent brain, spinal, or ophthalmic surgery, recent intracranial hemorrhage, known or suspected esophageal varices, arteriovenous malformations, Vascular aneurysms or major spinal or cerebral vascular malformations; (10) a history of drug or alcohol abuse; (11) pregnant, breastfeeding, or planning to become pregnant within one year; (12) The researchers judged that the patients had poor compliance and could not complete the study according to the requirements; Or other circumstances in which the investigator considers the subject to be unsuitable for the study. (13) The subject was planned to undergo LAAC combination with other cardiac procedure.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of complete endothelialization of the device; | — |
Secondary
| Measure | Time frame |
|---|---|
| Main incidence of clinical adverse events;Bleeding event; | — |
Countries
China
Contacts
Public ContactZhang Jun Feng
Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed