A Clinical Study on the Use of a Domestically Produced Cryoablation System Combined With Balloon Cryoablation Technology for the Treatment of Paroxysmal Atrial Fibrillation

Inclusion criteria

• Patient age between 18 and 80 years old, male or non-pregnant female.
• Confirmed diagnosis of paroxysmal atrial fibrillation requiring cryoablation surgery.
• Fully understands the treatment plan and voluntarily signs the informed consent form, willing to undergo the examinations, surgery, and follow-up required by the plan.

Exclusion criteria

• Patients who have undergone atrial fibrillation ablation surgery
• Reproductive-age patients who cannot use effective contraception within 12 months of enrolment
• Left atrial size ≥50 mm, left ventricular ejection fraction ≤40%
• Left atrial thrombus
• Patients who have undergone atrial septal defect repair surgery or atrial myxoma
• Patients with cerebrovascular disease within the past 3 months (including stroke or transient ischaemic attack)
• Patients with cardiovascular events within the past 3 months (including acute myocardial infarction, coronary artery intervention or bypass surgery, artificial valve replacement or repair, or atrial or ventricular incision)
• Patients with acute or severe systemic infection
• Patients with severe liver or kidney disease
• Patients with a significant tendency to bleed or haematological disorders
• Patients with malignant tumours or end-stage diseases
• Patients deemed ineligible for this trial by the investigator