Cryoballoon Pulmonary Vein Isolation for Paroxysmal Atrial Fibrillation

This post-marketing, multi-center, prospective, single-arm, observational study will be conducted across 3 clinical sites in China and enroll no more than 50 patients with paroxysmal atrial fibrillation. After clinical site initiation, each study site was permitted to enroll up to 2 roll-in cases to allow operators to familiarize themselves with the Nordica® cryoballoon and standardize procedural techniques. A competitive enrollment method will be adopted to recruit up to 50 patients with paroxysmal atrial fibrillation. The Nordica® cryoballoon will be employed for pulmonary vein isolation during the procedure. A 6-month follow-up assessment is scheduled at the following time points: the index hospitalization period (days 0-3), and post-procedure follow-up time points at 30 days, 3 months, and 6 months.

Inclusion Criteria: 1. Aged 18-75 years. 2. Documented paroxysmal atrial fibrillation (PAF), eligible for AF catheter ablation, and scheduled to undergo a cryoballoon-based pulmonary vein isolation. 3. Willing and able to complete all protocol-required study visits and assessments. 4. Ability to understand the study procedures and provide written informed consent. Exclusion Criteria: 1. Prior AF ablation (catheter-based), left atrial maze procedure, or any other pulmonary vein/left atrial intervention; 2. Left atrial (LA) diameter \>55 mm, or severe valvular heart disease requiring surgical intervention; 3. Left ventricular ejection fraction \< 40%; 4. Stroke, transient ischemic attack (TIA), acute coronary syndrome (ACS), Myocardial infarction (MI), Any cardiac surgical or percutaneous cardiac procedure within the last three months; 5. Left atrial/left atrial appendage thrombus; 6. Severe liver and/or renal insufficiency; 7. With bleeding tendency, contraindication for anticoagulation, or inability to tolerate oral anticoagulant therapy. 8. Pregnant or breastfeeding women; 9. with cryoglobulinemia; 10. Hypersensitivity reactions to contrast media; 11. Any factor that, in the investigator's judgment, renders the patient unsuitable for participation (such as mental illness, or inability to complete follow-up, etc.).