Atrial Fibrillation
Conditions
Interventions
PVI group:pulmonary vein isolation
CBXL group:extensive encircling pulmonary vein isolation+Ablation of left atrial roof line, mitral isthmus line, posterior line, anterior line and right atrial CTI is performed. If necessary, superior
Sponsors
Second Affiliated Hospital of Army Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients age 18-80 years. 2. Patients undergoing a first-time RF ablation procedure for AF. 3. Patients with non-valvular atrial fibrillation. 4. Persistent AF or long-term persistent AF with ECG-documented AF of >7 days and <5 years duration. 5. Presence of symptoms associated with AF, including but not limited to: palpitations, fatigue, dyspnea, presyncope or syncope. 6. Patients have at least one antiarrhythmic drug (AAD) therapy that is ineffective or intolerable, or the patient refuses to use any AAD 7. Patients must be willing to undergo RF ablation, and to be included in this trial. 8. Patients must be willing and able to sign informed consent, and to be followed up.
Exclusion criteria
Exclusion criteria: Paroxysmal AF, paroxysmal AF will be defined as a sustained episode lasting <7 d. 2. AF secondary to significant reversible factors. 3. Left atrial diameter = 60 mm (2-dimensional echocardiography, parasternal long-axis view). 4. Cardiac function classification NYHA class IV. 5. Left ventricular ejection fraction (LVEF) <30%. 6. Patients require triple antithrombotic (aspirin + clopidogrel + oral anticoagulant) or dual antithrombotic (clopidogrel + oral anticoagulant), e.g., has undergone percutaneous transluminal coronary angioplasty (PTCA)/stenting at 90 days. 7. The presence of contraindications to anticoagulant therapy in the patient. 8. Patients who are pregnant. 9. Life expectancy of less than 1 year (e.g., advanced malignancy). 10. Endogenous creatinine clearance < 30 ml/min. 11. Moderate or greater anemia (Hb < 90g/L) 12. Left atrial or left atrial appendage thrombus. 13. Previous prosthetic valve replacement. 14. Moderate or severe mitral stenosis (mitral valve orifice area =1.5 cm2) 15. Severe structural heart disease, including: severe mitral valve insufficiency (mitral regurgitation area =8 cm2), dilated cardiomyopathy, hypertrophic cardiomyopathy, other severe valvular heart disease. 16. Previous occurrence or current hyperthyroidism or hypothyroidism. 17. Previous ablation therapy (including transcatheter ablation therapy and surgical ablation therapy) for AF.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| atrial tachyarrhythmia; | — |
Secondary
| Measure | Time frame |
|---|---|
| The incidence of atrial tachyarrhythmia (including atrial fibrillation, atrial flutter, and atrial tachycardia with a duration of 30 s or more) after a blanking period of 3 months after a single ablation procedure, with or without antiarrhythmic drugs.;The incidence of atrial fibrillation with a duration of more than 30 s without the use of antiarrhythmic drugs after a blank period of 3 months after a single ablation.;The incidence of atrial tachyarrhythmias (including atrial fibrillation, atrial flutter and atrial tachycardia with a duration of more than 30 s) after multiple ablation procedures and after a blanking period of 3 months, with or without the use of antiarrhythmic drugs.;Incidence of surgery-related complications. Including: pericardial effusion, pericardial tamponade, pericardial tamponade requiring surgical intervention, stroke/body circulation embolism/TIA, phrenic nerve injury, death, pulmonary vein stenosis, left AV esophageal fistula, and vascular puncture complications (including hematoma/pseudoaneurysm/arterio-venous fis; | — |
Countries
China
Contacts
Public ContactTan Hu
Second Affiliated Hospital of Army Medical University
Outcome results
None listed