Paroxysmal atrial fibrillation
Conditions
Interventions
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age =18 to =75 years old, gender is not limited. 2. Symptomatic paroxysmal atrial fibrillation (AF) was diagnosed. Symptomatic paroxysmal atrial fibrillation is defined as atrial fibrillation that terminates spontaneously or with treatment within 7 days of spontaneous onset. Relevant data recorded by electrocardiogram, holter electrocardiogram test, implantable device or similar device in the year prior to enrollment. 3. Patients with poor response after at least one type I or type III AAD treatment, or who cannot tolerate type I or type III AAD treatment. 4. Subjects are willing to comply with the requirements of the study protocol to complete follow-up and related examinations, and voluntarily sign a written informed consent.
Exclusion criteria
Exclusion criteria: 1. Persistent atrial fibrillation (continuous atrial fibrillation lasting >7 days) 2. Atrial fibrillation caused by electrolyte disturbance, thyroid disease, reversible or non-cardiac causes 3. Patients with tachyatrial arrhythmia retreated after ablation 4. Clear combined atrial flutter and atypical atrial flutter 5. Left atrial diameter (echocardiography) > 47mm 6. Previous left atrial ablation or surgical procedures (including left atrial appendage closure) 7. Carry a permanent pacemaker, biventricular pacemaker, loop recorder/plug-in heart monitor (ICM), or any type of implantable cardiac defibrillator (with or without biventricular pacing) 8. History of anticoagulation contraindications, blood clotting or abnormal bleeding; 9. Severe lung disease, pulmonary hypertension or any lung disease involving severe breathing difficulties such as abnormal blood gas 10. Any heart surgery, implant or condition listed below: • Artificial valve • NYHA III or IV, congestive heart failure, or left ventricular ejection fraction (LVEF) < 40% • atrial septal or ventricular septal defect closure • Atrial myxoma, left atrial appendage device or occlusion, 11. Any of the following medical history occurred in the 3 months prior to surgery: • Myocardial infarction • Unstable angina • Percutaneous coronary intervention • Heart surgery, including coronary artery bypass grafting • Hospitalization for heart failure • Pericarditis or pericardial effusion 12. Medical history of any of the following within 6 months prior to surgery: • Cerebral infarction, transient ischemic attack • Any thromboembolic events recorded (e.g. transesophageal echocardiography TEE) 13. History of malignant tumor or life expectancy <12 months. 14. Mental disorder or history of mental illness and inability to cooperate voluntarily 15. Women who are lactating, pregnant and planning or likely to become pregnant 16. Acute or severe systemic infection, obvious abnormal liver and kidney function 17. Are participating in other interventional clinical trials, or are judged by the investigator not suitable for inclusion in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 12 months after operation success rate;Major adverse events occurring rate within 7 days postoperatively; | — |
Secondary
| Measure | Time frame |
|---|---|
| Immediate success rate;Product performance evaluation;Indicators of operation and ablation;Adverse events, severe adverse events, occurrence of adverse events related to the trial device; | — |
Countries
China
Contacts
Public ContactRui Zeng
West China Hospital, Sichuan University
Outcome results
None listed