FIH Study of PFLotus in Persistent Atrial Fibrillation

Prior treatment

• Pulmonary vein (PV) stenosis (\>70%) or prior PV stent implantation
• 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 \[TEE\])

Other illness

• AF caused by electrolyte disorders, thyroid diseases, or reversible/non-cardiac etiologies
• 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
• History of malignant tumor or expected life expectancy \< 12 months
• Mental disorders or history of mental illness with inability to cooperate independently
• Acute or severe systemic infection, or significant abnormalities in liver/renal function

Lab values

• 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

Other

• Paroxysmal atrial fibrillation (AF)
• Patients undergoing retreatment after ablation for rapid atrial tachyarrhythmias
• Patients with sustained ventricular tachycardia or ventricular fibrillation
• Left atrial anteroposterior diameter \> 55 mm
• Lactating, pregnant, or women planning or potentially becoming pregnant
• Participation in other interventional clinical trials, or ineligibility for enrollment as judged by the investigator

• 1\. 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.
  • 3\. 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.
  • 4\. Willing to participate in the trial, comply with the follow-up requirements specified in the protocol, and sign the informed consent form.