Efficacy and Safety of Individualized Pulsed Field Ablation Guided by Pulmonary Vein Antral Substrate Mapping for Atrial Fibrillation: A Prospective, Single-Center, Single-Arm Study

This study will adopt a prospective, single-center, single-arm research design, enrolling 120 patients with paroxysmal or persistent atrial fibrillation who are scheduled to undergo catheter ablation for the first time. Individualized pulsed electrical field pulmonary vein isolation will be performed under the guidance of pulmonary vein vestibular stromal mapping. By recording the distribution characteristics of abnormal stroma in the pulmonary vein vestibule, the guidance situation of the ablation strategy based on the mapping results, surgical and ablation parameters, immediate pulmonary vein isolation effect, perioperative complications, and the 12-month recurrence-free survival rate of atrial arrhythmias after surgery, the feasibility, effectiveness and safety of this ablation strategy will be evaluated, and the relationship between the characteristics of pulmonary vein vestibular stroma and postoperative recurrence will be explored. This will provide more clinical experience and data support for individualized ablation under the guidance of pulmonary vein vestibular stromal mapping.

Inclusion Criteria: * (1) Age 18 and above, gender not restricted; (2) Diagnosed with paroxysmal/ persistent atrial fibrillation through electrocardiogram or ambulatory electrocardiogram, and undergoing the first cardiac ablation procedure; (3)Agree to participate in this study and be able and willing to comply with all follow-up requirements. Exclusion Criteria: * (1) Atrial fibrillation is secondary to electrolyte imbalance, thyroid disorders, or other reversible or non-cardiac causes; (2) Previous history of left atrial ablation or surgical procedures (including left atrial occlusion surgery); (3) Left atrial or left atrial appendage thrombus; (4) Pulmonary vein stenosis or those who have received pulmonary vein stent implantation; (5) Patients who have undergone atrial septal repair or atrial myxoma; (6) Left atrial anterior-posterior diameter ≥ 50 mm; (7) Left ventricular ejection fraction (LVEF) \< 40%; (8) New York Heart Association (NYHA) functional class III and IV; (9) Patients with cerebrovascular diseases within the past 3 months (including stroke, transient ischemic attack); (10) Patients with cardiovascular events within the past 3 months (including acute myocardial infarction, coronary intervention, coronary artery bypass surgery, artificial valve replacement or repair, atrial or ventricular incision surgery); (11) Patients with acute or severe systemic infections; (12) Patients with severe liver or kidney diseases; (13) Patients with obvious bleeding tendency and hematological diseases; (14) Patients with malignant tumors and end-stage diseases; (15) Rheumatic heart disease; (16) Subjects who are pregnant or breastfeeding or unable to use contraception during the trial; (17) Subjects who have participated in other drug or device clinical trials at the same time; (18) Researchers consider that certain abnormalities or diseases should be excluded from the inclusion criteria of this study.