Paroxysmal atrial fibrillation
Conditions
Interventions
Pulsed field ablation group:The CardioPulse Pulse Ablation System will be administered to the study subjects through catheter-based pulse ablation.
Sponsors
Cardiology Department, West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1)Patients aged between 18 and 80 years old, inclusive (including 18 and 80 years old). 2)Patients with symptomatic paroxysmal atrial fibrillation. 3)Ability to comprehend the purpose of the clinical trial, voluntary participation in the study, and willingness to sign the informed consent form, as well as a commitment to completing the follow-up according to the protocol requirements.
Exclusion criteria
Exclusion criteria: 1)Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or other reversible causes. 2)Prior surgical or catheter ablation treatment for atrial fibrillation. 3)History of left atrial appendage occlusion or closure surgery. 4)Myocardial infarction (MI) or coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) within the past 6 months. 5)Carotid artery stenting or carotid endarterectomy within the past 6 months. 6)Baseline left ventricular ejection fraction (LVEF) <40% or New York Heart Association (NYHA) functional class III and IV. 7)Left atrial anteroposterior diameter =50 mm. 8)Presence of implanted devices such as ICD, CRT, and pacemakers. 9)Imaging evidence of left atrial or left atrial appendage thrombus. 10)Rheumatic heart disease. 11)Uncontrolled hypertension. 12)Hypertrophic cardiomyopathy, with significant myocardial thickness =15mm. 13)Documented thromboembolic events within the past 6 months, including transient ischemic attacks. 14)Presence of intracardiac thrombus, tumors, or other abnormalities hindering vascular puncture or catheter manipulation. 15)Severe pulmonary diseases, pulmonary hypertension, or any pulmonary condition causing gas exchange abnormalities or severe respiratory distress. 16)Contraindications to anticoagulation and a history of blood clotting or bleeding abnormalities. 17)Acute systemic infection. 18)Serum creatinine greater than twice the normal upper limit or any history of renal dialysis. 19)Pregnant or lactating females or females unable to use contraception during the clinical trial. 20)Concurrent participation in other drug or medical device clinical studies. 21)Expected life expectancy less than 12 months (e.g., advanced malignancy). 22)Other anomalies or diseases deemed by the investigator to warrant exclusion from the scope of this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Long-term success rate (proportion of maintained sinus rhythm);Postoperative Major Adverse Events (MAE) Related to Devices or Surgery Incidence Rate.; | — |
Secondary
| Measure | Time frame |
|---|---|
| acute pulmonary vein isolation;Surgical Procedure Duration;Improvement in Quality of Life;Rehospitalization Rate Due to Cardiovascular Events During Follow-up; | — |
Countries
China
Contacts
Public ContactRui Zeng
West China Hospital, Sichuan University
Outcome results
None listed