Clinical Trial of the Pulse Field Ablation System for the Treatment of Paroxysmal Atrial Fibrillation in 11 Centers in China
Paroxysmal Atrial Fibrillation
About this trial
This is an interventional treatment trial for Paroxysmal Atrial Fibrillation focused on measuring Pulse Field Ablation Catheter
Eligibility Criteria
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
Sites / Locations
- the Second Affiliated Hospital of Sun Yat-sen University (Sun Yat-sen Memorial Hospital)
Arms of the Study
Arm 1
Experimental
experimental group
Each subject underwent pulse ablation catheter ablation