Atrial fibrillation
Conditions
Interventions
Group 1:ablation first
Group 2:LAAC first
Sponsors
Ningbo First Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients who are aged of 18 years or older; 2. Patients with symptomatic non-valvular atrial fibrillation (AF); 3. With indication of catheter ablation who is refractory to antiarrhythmic drugs; 4. CHA2DS2-VASc score >= 2 ( >= 3 for female patients), including one of the following criteria: (1) with contraindications for long-term anticoagulation therapy; (2) with thromboembolic events despite of the anticoagulation therapy; (3) HAS-BLED score >= 3; 5. The maximum diameter of the left atrial appendage (LAA) ostium is no larger than 30mm with proper working depth for LAA closure (LAAC) assessed by either transesophageal echocardiography (TEE) or computed tomography angiography (CTA) prior to the procedure; 6. The maximum diameter of the left atrium (LA) is no larger than 50mm assessed by transthoracic echocardiography (TTE) prior to the procedure; 7. Acceptance of the participation to the study and written consent are accessible from the patient him-/herself or authorized relatives.
Exclusion criteria
Exclusion criteria: 1. Patients with comorbidities such as congenital heart disease, valvular heart disease, angina pectoris, myocardial infarction, myocarditis, cardiomyopathy, cor pulmonale, severe infection, autoimmune disease, hematological system diseases, malignant tumor, et al; 2. Patients suffering from arrhythmias other than AF, such as atrioventricular reciprocating tachycardia, atrioventricular nodal reentrant tachycardia, preexcitation syndrome, atrioventricular block, sick sinus syndrome, et al; 3. Previous percutaneous coronary intervention or radiofrequency catheter ablation or cryoablation of AF; 4. Cardiac dysfunction (NYHA class >= III), or left ventricular ejection fraction 3x upper limits of normal) or renal dysfunction (SCr > 3.5mg/dl or CCr < 30ml/min); 9. Previous cardiac surgery within last 6 months; 10. Contraindications to catheter ablation therapy (including pregnancy status, allergic to contrast, et al.); 11. Life expectancy less than 12 months; 12. Participation in previous clinical trials within 3 months or ongoing clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| LAAC success rate;acute complete sealing rate;Incidence of peri-device leaks during follow-up;Percentage of discontinuation of oral anticoagulants;freedom from atrial fibrillation or tachycardiac arrhythmia at one year; | — |
Secondary
| Measure | Time frame |
|---|---|
| procedure-related parameters;peri-procedural complication rate;incidence of adverse events during follow-up; | — |
Countries
China
Contacts
Public ContactHuimin Chu
Arrhythmia Diagnosis and Treatment Center of Ningbo First Hospital
Outcome results
None listed