Non-valvular atrial fibrillation
Conditions
Interventions
Experimental group:Implant trial device by operation
Sponsors
Zhongshan Hospital affiliated to Fudan University/Shanghai 10th People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. CHA2DS2-VASc scores >= 2 in patients with non-valvular atrial fibrillation; 2. It meets one of the following circumstance: (1) The patients who are contraindication of long-term oral anticoagulation therapy. (2) Patients with stroke or thromboembolism still occur on the basis of warfarin and international standardized ratio (INR). (3) HAS-BLED scores >= 3. (4) Patients unwilling/unable to tolerate long-term oral anticoagulation therapy. 3. Aged >= 18 years. 4. Voluntary participation in this clinical trial and informed consent signed.
Exclusion criteria
Exclusion criteria: (1) Incidental atrial fibrillation. (2) There are contraindications to the use of warfarin, aspirin, or clopidogrel. (3) There were serious myocardial infarction or serious coronary artery imaging in the past 3 months. (4) Stroke in recent 30 days. (5) There is a plan of radiofrequency ablation or electrical cardioversion will be performed within 30 days after the implantation of left atrial appendage occluder. (6) Patients who have undergone heart-related operations such as left atrial appendectomy (no obvious residual cavity), mechanical heart valve replacement, atrial septal defect occluder implantation, heart transplantation, etc., are no longer suitable for left atrial appendage occlusion. (7) Complicated with hemorrhagic diseases and unhealed peptic ulcer. (8) Complicated with venous thromboembolism, including not limited to cerebral, liver, kidney, mesenteric venous thrombosis. (9) Merge any type of active infection. (10) Combined with other diseases besides atrial fibrillation requiring warfarin anticoagulation therapy. (11) Patients with other serious diseases of various systems, including not limited to severe hypotension, shock, pulmonary insufficiency, malignant tumors. (12) Patients with thrombocytopenia (?60,000/mm3). (13) Atrial anteroposterior diameter > 65mm, transesophageal echocardiography (TEE) revealed intracardiac thrombosis and/or left atrial dense spontaneous development, pericardial effusion > 3mm, cardiac tumors, and intracardiac neoplasms. (14) Left atrial appendage diameter 35 mm or depth <10mm were measured by TEE. (15) Left ventricular ejection fraction (LVEF) < 0.35. (16) Grade III or IV of cardiac function (NYHA) without correction. (17) Patients with a predicted survival of less than 1 year. (18) Pregnancies or planned pregnancies during this trial. (19) Patients who had participated in other clinical trials within one month before admission were enrolled. (20) Researchers believe that patients who are not eligible to participate in this clinical trial are not eligible.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of complex endpoint events up to 12 months after the procedure; | — |
Secondary
| Measure | Time frame |
|---|---|
| Effective closure rate of the operation;Incidence rate of complication after procedure;The effect of LAA closure after the procedure.;Incidence of ischemic events after procedure.;Incidence of hemorrhagic events.;The proportion of all-cause deaths.;Qualification rate of equipment performance; | — |
Countries
China
Contacts
Public ContactJunbo Ge/Yawei Xu
Zhongshan Hospital affiliated to Fudan University/Shanghai 10th People's Hospital
Outcome results
None listed