persistent atrial fibrillation
Conditions
Interventions
Intervention group:pulsed electric filed ablation
Sponsors
Beijing Anzhen Hospitai, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-80 years (inclusive); 2. Non-valvular atrial fibrillation catheter ablation was performed for the first time; 3. The duration of atrial fibrillation is greater than 3 months and less than 3 years. 4. Continuous atrial fibrillation recorded by ECG/Holter/ remote monitoring or implantable device within 6 months prior to inclusion; 5. The patient has symptoms related to atrial fibrillation, including but not limited to palpitation, threatened syncope/syncope, fatigue, and shortness of breath; 6. The use of one or more antiarrhythmic drugs (AAD) is not effective/effective/patients are reluctant to use AAD for a long time; 7. Agreed to receive pulsed electric field ablation and Marshall venous chemical ablation if necessary; 8. Agree to sign an informed consent form and follow up.
Exclusion criteria
Exclusion criteria: 1. Patients who have previously undergone ablation of atrial fibrillation; 2. Previous history of left atrial surgery; 3. Intracardiac thrombus; 4. Patients with pulmonary vein stenosis or with implanted pulmonary vein stents; 5. Left anteroposterior atrial diameter > 5.5cm (measured by transthoracic echocardiography, transesophageal echocardiography, or cardiac CT); 6. There are serious arrhythmias except AF, AFL and AT; 7. After clinically significant mitral stenosis or regurgitation, any heart valve prolapse or valve replacement; 8. Patients with acute myocardial infarction, unstable angina pectoris, percutaneous coronary intervention (PCI), cardiac surgery, hospitalization for heart failure, stroke or transient ischemic attack (TIA), clinically significant bleeding event, and pericardial effusion 3 months before surgery; 9. Patients with bleeding tendency, coagulopathy, or any anticoagulant contraindications; 10. Corrected/uncorrected severe congenital heart malformations, after repair/closure of atrial septal/ventricular septal defects; 11. NYHA Grade III or IV or left ventricular ejection fraction (LVEF) < 35%; 12. Second degree type II or third degree atrioventricular block; 13. Primary pulmonary hypertension; 14. Rheumatic heart disease; 15. Patients with a history of pericarditis; 16. Patients with past left atrial appendage occlusion/closure, or patients who plan to undergo left atrial appendage occlusion; 17. Having any type of cardiac implantable electronic device (CIED); 18. Hypertrophic cardiomyopathy; 19. Patients with severe renal insufficiency (eGFR < 30ml/min/1.73m^2) or previous dialysis or renal replacement therapy; 20. Participating or planning to participate in other interventional clinical studies; 21. Patients in pregnancy; 22. Circumstances in which the investigator considers it inappropriate to participate in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The success rate in 12 months after operation treatment without AADs; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pulmonary vein isolation;Symptomatic recurrence rate at 12 months after operation without AADs;The time between surgery and recurrence of the first occurrence of atrial fibrillation (AF), atrial flutter (AFL), and atrial tachycardia (AT);The performance evaluation about products; | — |
Countries
China
Contacts
Public ContactMa Changsheng
Beijing Anzhen Hospitai, Capital Medical University
Outcome results
None listed