FIH Study of PFLotus in Persistent Atrial Fibrillation

Inclusion criteria

• \. Aged between 18 and 75 years (inclusive), regardless of gender 2. Diagnosed with symptomatic persistent atrial fibrillation (AF). The patient's medical records document that the duration of AF episodes exceeds 7 days or the patient has a history of persistent AF, and meets \*\*any one\*\* of the following criteria:
• A 24-hour ambulatory electrocardiogram (Holter) recorded within 365 days prior to enrollment shows AF throughout the monitoring period.
• Two electrocardiograms (ECGs) obtained at an interval of more than 7 days within 365 days prior to enrollment both demonstrate AF.
• \. Poor response to treatment with at least one class I or class III antiarrhythmic drug (AAD), or intolerance to class I or class III AADs.
• \. Willing to participate in the trial, comply with the follow-up requirements specified in the protocol, and sign the informed consent form.

Exclusion criteria

• Paroxysmal atrial fibrillation (AF)
• AF caused by electrolyte disorders, thyroid diseases, or reversible/non-cardiac etiologies
• Patients undergoing retreatment after ablation for rapid atrial tachyarrhythmias
• Patients with sustained ventricular tachycardia or ventricular fibrillation
• Left atrial anteroposterior diameter \> 55 mm
• Pulmonary vein (PV) stenosis (\>70%) or prior PV stent implantation
• History of left atrial ablation or cardiac surgery (including left atrial appendage closure)
• Implantation of permanent pacemaker, biventricular pacemaker, loop recorder/insertable cardiac monitor (ICM), or any type of implantable cardioverter-defibrillator (with or without biventricular pacing function)
• Contraindications to anticoagulation, or history of coagulation or bleeding abnormalities
• Severe pulmonary disease: severe pulmonary arterial hypertension or any pulmonary disease with severe dyspnea involving blood gas abnormalities
• Any of the following cardiac surgeries, implants, or conditions:
• Prosthetic heart valve
• NYHA Class III or IV congestive heart failure, or left ventricular ejection fraction (LVEF) \< 40%
• Atrial septal defect or ventricular septal defect closure
• Atrial myxoma, left atrial appendage device implantation or occlusion
• History of any of the following within 3 months prior to the procedure:
• Myocardial infarction
• Unstable angina
• Percutaneous coronary intervention
• Cardiac surgery (including coronary artery bypass grafting)
• Hospitalization for heart failure
• Pericarditis
• History of any of the following within 3 months prior to the procedure:
• Cerebral infarction or transient ischemic attack (TIA)
• Documented thromboembolic events (e.g., confirmed by transesophageal echocardiography \[TEE\])
• History of malignant tumor or expected life expectancy \< 12 months
• Mental disorders or history of mental illness with inability to cooperate independently
• Lactating, pregnant, or women planning or potentially becoming pregnant
• Acute or severe systemic infection, or significant abnormalities in liver/renal function
• Participation in other interventional clinical trials, or ineligibility for enrollment as judged by the investigator