Atrial Fibrillation
Conditions
Interventions
ICE group:ICE-guided LAAC procedures
TEE group:TEE-guided LAAC procedures
Sponsors
Ningbo First Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients who can't tolerate or are unwilling to accept TEE examination, or who are not suitable for TEE examination due to esophageal lesions (infection, ulcer, space occupying, etc.); 2; 2. Patients with atrial septal puncture difficulties predicted by the operator (such as dextrocardia, spinal deformity, cardiac transposition, less experience of atrial septal puncture under X-ray, etc.); 3. Patients with renal insufficiency or allergic to contrast medium; 4. Patients who are not suitable for X-ray exposure due to special constitution or physiological state, or who are allergic to X-ray irradiation; 5. Patients whose left atrial appendage occlusion effect cannot be accurately judged under X-ray.
Exclusion criteria
Exclusion criteria: 1. Patients with congenital heart disease, valvular heart disease, acute myocardial infarction, severe myocarditis, pulmonary heart disease, severe infection, autoimmune disease, hematological disease and malignant tumor; 2. Patients with NYHA grade IV or left ventricular ejection fraction <= 35% by echocardiography, who can not tolerate LAAC operation; 3. Patients with thrombus in left atrium or left atrial appendage (confirmed by ice or tee or CCTA before operation); 4. Those patients who underwent one-stop surgery for atrial fibrillation; 5. Patients with serious nervous system diseases and mental diseases (including drug abuse, chronic alcoholism, etc.); 6. Patients who cannot tolerate short-term oral anticoagulation or antiplatelet aggregation therapy after operation; 7. Patients with a history of cardiac surgery in the past 6 months; 8. Patients with life expectancy less than 12 months; 9. Subjects who have participated in other clinical studies within 3 months before the date of informed consent or are participating in other clinical studies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| LAAC acute success rate;acute complete closure rate;Incidence of peri-device leaks during follow-up;Percentage of discontinuation of oral anticoagulants; | — |
Secondary
| Measure | Time frame |
|---|---|
| procedure-related parameters;peri-procedural complication rate;incidence of adverse events during follow-up; | — |
Countries
China
Contacts
Public ContactHuimin Chu
Cardiac Arrhythmia Center, Ningbo First Hospital
Outcome results
None listed