Non-valvular atrial fibrillation
Conditions
Interventions
ICE-Guided Transseptal Puncture and Left Atrial Appendage Closure via the Right Atrium:ICE-Guided Transseptal Puncture and Left Atrial Appendage Closure via the Right Atrium
ICE-guided LAA in the LA:ICE guides transseptal puncture from the right atrium
after successful puncture, the ICE catheter is advanced into the left atrium to guide LAAC through the same hole.
Sponsors
Shanghai East Hospital
Eligibility
Sex/Gender
All
Age
19 Years to 84 Years
Inclusion criteria
Inclusion criteria: 1. Patients with paroxysmal/persistent/long-standing persistent non-valvular atrial fibrillation (NVAF) 2. CHA2DS2-VASC score: >=2 points in males and >=3 points in females; 3. Age > 18 years and < 85 years 4. Having indications for long-term anticoagulant therapy 5. Left atrial diameter < 65 mm 6. Subjects are able to tolerate and cooperate with left atrial appendage closure (LAAC) performed under local anesthesia 7. Subjects or their legal representatives can understand and are willing to sign the informed consent form to participate in this trial, and agree to cooperate with follow-up and research procedures.
Exclusion criteria
Exclusion criteria: 1. Age >= 85 years; 2. Left atrial diameter >= 65 mm; 3. Patients with thrombus or suspected thrombus in the left atrium (LA) or left atrial appendage (LAA) detected by preoperative transesophageal echocardiography (TEE) or cardiac computed tomography angiography (CCTA); 4. Patients with complex anatomical structure of the LAA indicated by preoperative TEE or CCTA (e.g., excessively small or large LAA ostium, or complex anatomical structure without suitable occluder available), who are not eligible for left atrial appendage closure (LAAC) under current technical and equipment conditions; 5. Patients with left ventricular ejection fraction (LVEF) = 10 mm at the cardiac base or posterior wall detected by TTE; 7. Patients with other diseases requiring long-term anticoagulant therapy besides atrial fibrillation (e.g., post mechanical heart valve replacement, spontaneous or recurrent venous thromboembolism, etc.); 8. Patients with rheumatic heart valve disease, moderate to severe mitral stenosis (valve orifice area <= 1.5 cm^2), or post mechanical heart valve replacement; 9. Patients with severe valvular heart disease or cardiac structural abnormalities (e.g., large atrial septal defect [ASD], ventricular septal defect [VSD]) requiring surgical intervention, or severe coronary artery disease (CAD) requiring coronary artery bypass grafting (CABG); 10. Patients with new-onset ischemic stroke/transient ischemic attack (TIA) without hemorrhagic transformation, but deemed ineligible for initiating anticoagulant therapy by the National Institutes of Health Stroke Scale (NIHSS) score and neurological physician assessment; 11. Patients with acute ischemic stroke complicated by hemorrhagic transformation or intracranial hemorrhage induced by oral anticoagulant therapy, who are deemed ineligible for resuming anticoagulant therapy by multidisciplinary team (MDT) assessment; 12. Active peptic ulcer with bleeding within 3 months; 13. Patients with coagulation disorders or coagulation factor deficiencies; 14. Expected survival time < 1 year; 15. Uncontrolled heart failure (New York Heart Association [NYHA] Functional Class IV).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The technical success rate of LAAC; | — |
Secondary
| Measure | Time frame |
|---|---|
| Left Atrial Appendage Occlusion Rate at 3 Months Postoperatively;Incidence of Residual Atrial Septal Defect Confirmed by TEE at 3 Months Postoperatively; | — |
Countries
China
Contacts
Public ContactHe Ben
Shanghai East Hospital
Outcome results
None listed