Safety-and-effectiveness Clinical Evaluation of Nanosecond-pulse Ablation for Atrial Fibrillation

Inclusion criteria

Subjects must meet all of the following conditions to be enrolled:

• 18 to 80 years of age, gender is not limited
• Patients with a clinical diagnosis of paroxysmal atrial fibrillation confirmed by ECG
• Patients who were to undergo catheter ablation of atrial fibrillation
• Those who agreed to participate in this study and voluntarily signed the informed consent form

Exclusion criteria

Subjects were excluded if they met one of the following conditions:

• Patients who have had ablation for atrial fibrillation
• Patients with left ventricular ejection fraction (LVEF) <35%.
• Patients with an anteroposterior diameter of the left atrium (echocardiography) >50 mm
• Preoperative detection of a definite thrombus in the left atrium
• Patients with cardiac function class (NYHA) III-IV
• Patients with second-degree (type II) or third-degree atrioventricular block
• Patients with significant congenital heart defects (including atrial septal defect, ventricular septal defect, arterial ductus arteriosus, transposition ofthe grea, or severe pulmonicvalve, but not including foramen ovale persistens)
• Patients with implanted prosthetic valves or the presence of severe heart valve disease, who are not suitable for ablation for atrial fibrillation
• Patients with artificial cardiac pacemaker or implantable cardioverter defibrillator (ICDs)
• Patients diagnosed with hypertrophic obstructive cardiomyopathy, chronic obstructive pulmonary disease, or myxoma
• Patients who need to undergo left atrial appendage closure in the same surgery
• Patients found to have atrial flutter preoperatively and judged unsuitable by the investigators, or patients with atrial parasystolic tachycardia (non-pulmonary venous origin) or paroxysmal supraventricular tachycardia
• Patients with active systemic infection who are judged unsuitable for interventional therapy by the investigators
• Patients with systemic bleeding tendencies that preclude surgery or patients with renal failure undergoing hemodialysis
• Patients who have had a myocardial infarction or any interventional/open heart surgery (except coronary angiography) within 3 months
• Patients who have had a stroke (except asymptomatic stroke) or transient ischemic attack within 3 months
• Patients with significant contraindications to interventional procedures or with an expected survival of <1 year who are judged by the investigator to be incapable of undergoing ablative procedures
• Females who are pregnant or breastfeeding or who are planning to have children during the study period
• Patients who have participated in a clinical trial of another drug or medical device within 3 months
• Patients who, in the opinion of the investigator, are not suitable for participation in this clinical trial