patients with non-valvular atrial fibrillation
Conditions
Interventions
experimental group:The experimental device was inserted via the femoral vein to perform atrial septal puncture and reach the left atrium. The bottom of the left atrial appendage was grasped and everte
Sponsors
Guangdong Provincial People’s Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age > 18 years old and = 2 (>= 3 for females), and meeting any of the following conditions: (1) Unable to tolerate long-term anticoagulant therapy; (2) Unwilling to use anticoagulant drugs for a long time; (3) Had a stroke or embolism event despite standardized anticoagulant treatment; (4) Predicted bleeding risk (HAS-BLED) score >= 3. 4. The subjects have been fully informed , understand the purpose of the clinical trial, and voluntarily participate and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Subjects with rheumatic heart valve disease, moderate to severe mitral stenosis, severe mitral regurgitation, severe aortic valve disease, and severe left ventricular outflow tract obstruction with a pressure gradient greater than 40 mmHg; 2. Subjects who have undergone cardiac surgery with open-chest approach, mitral valve replacement, transcatheter mitral intervention, or mechanical valve implantation; 3. Subjects who have undergone left atrial appendage closure or left atrial closure surgery ; 4. Subjects with a history of atrial septal/ostium primum repair or atrial septal/ostium primum occluder implantation; 5. Subjects who have new-onset stroke or TIA within 30 days before the operation; 6. Subjects who have received or plan to receive any cardiac or non-cardiac interventional surgery or surgical operation within 30 days before the operation or within 60 days after implantation; 7. Subjects who have undergone left atrial ablation within 90 days before the operation or plan to undergo left atrial ablation within 90 days after the operation; 8. Subjects who have suffered a myocardial infarction within 3 months prior to the operation; 9. Subjects who have had acute peptic ulcer within 3 months or history of gastrointestinal bleeding within 3 months; 10. Subjects who need concurrent antibiotic treatment due to active infection (if it is a temporary disease, the patient needs to stop using antibiotics for at least 14 days before enrollment); 11. Subjects with bleeding disorders or coagulation disorders; 12. Subjects with other diseases that require long-term anticoagulation therapy (such as mechanical valve replacement post-operation, spontaneous or recurrent venous thromboembolism, etc.), except for atrial fibrillation; 13. Subjects with symptomatic carotid artery disease (such as carotid stenosis > 50%) or subjects with vulnerable plaques in the carotid artery; 14. Subjects with severe heart failure (NYHA cardiac function IV grade); 15. Subjects with severe renal insufficiency (serum creatinine > 3 mg/dl or > 265 umol/L, or GFR < 30 mL/min/1.73m2 or requiring renal replacement therapy); 16. Subjects whose study investigators judge that there are conditions affecting sheath tube delivery (such as inability of the femoral vein to accommodate a 14F catheter or presence of inferior vena cava filter, or presence of femoral vein malformation, etc.); 17. Subjects who are allergic or contraindicated to aspirin, clopidogrel, heparin, or contrast agents; 18. Subjects with an expected lifespan of less than 12 months; 19. Pregnant or lactating women, or subjects with a future one-year fertility plan; 20. Subjects who have participated in other drug or medical device clinical trials before but have not reached the time limit for the primary research endpoint; 21. Subjects who, in the investigator's judgment, are not suitable for left atrial appendage ligation treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical success rate at 1 month post-operation;Left atrial appendage closure rate 6 months post-operation; | — |
Secondary
| Measure | Time frame |
|---|---|
| The immediate success rate of the instruments after the operation;Surgical success rate (within 7 days after the operation or before discharge);Clinical success rate before discharge, at 6 months and 12 months;Left atrial appendage closure rate at 1 month and 12 months after the operation;Evaluate the changes in the volume of the left atrial appendage stump based on the results of cardiac CTA examinations before discharge, 30 days after the operation, at 6 months and 12 months;Major adverse events (MAE) related to the device at 30 days, 6 months and 12 months after the operation;The incidence rate of device-related thrombosis before discharge, 30 days after the operation, 6 months and 12 months after the operation;The incidence rate of the need for a secondary intervention surgery due to the dysfunction related to the left atrial appendage ligation before discharge, 30 days after the operation, 6 months and 12 months after the operation;Serious bleeding events before discharge, 30 days after the operation, 6 months and 12 months after the operation;The incidence rate of stroke (ischemic, hemorrhagic or unclassified) and transient ischemic attack (TIA);The incidence rate of moderate to severe mitral stenosis (mitral valve orifice area < 1.5 cm2) after ligation before discharge, 30 days after the operation, at 6 months and 12 months after the operation;The incidence rate of moderate to severe stenosis at the opening of the left pulmonary vein (stenosis degree = 50%) after ligation before discharge, 30 days after the operation, at 6 months and 12 months after the operation;The changes in the left atrial internal diameter, left ventricular ejection fraction and left ventricular volume after the left atrial appendage ligation before discharge, 30 days after the operation, at 6 months and 12 months after the operation;The secretory function of the left atrial appendage before discharge, 30 days after the operation, at 6 months and 12 months after the operation; | — |
Countries
China
Contacts
Public ContactZhicheng Jing
Guangdong Provincial People’s Hospital
Outcome results
None listed