POLARx Post Approval Study (POLARx PAS)

Prospective Multi-Site Safety and Effectiveness Study of the Boston Scientific Cardiac Cryoablation System for Drug Refractory, Recurrent Symptomatic Paroxysmal Atrial Fibrillation

To collect clinical data on safety, effectiveness and procedural success of Boston Scientific's Cardiac Cryoablation System (includes all BSC commercially available POLARx/POLARx Fit catheters) when used to perform pulmonary vein isolation (PVI) in the ablation treatment of de novo Atrial Fibrillation (AF).

Inclusion Criteria:

• Subjects indicated for drug refractory, recurrent symptomatic PAF treatment with the Cryoablation System, per physician's medical judgement, and as per standard of care
• Subjects who are willing and capable of providing informed consent;
• Subjects who are willing and capable of participating in all testing associated with this clinical study at an approved clinical investigational center;

Exclusion Criteria:

• Any known contraindication to an AF ablation or anticoagulation, including those listed in the IFU as legally approved conditions;
• Any prior LA ablation;
• Known or pre-existing severe PV Stenosis;
• Subjects with severe valvular disease OR with a prosthetic - mechanical or biological - heart valve (not including valve repair and annular rings);
• Presence of any pulmonary vein stents;
• Subjects with active systemic infection;
• Subject is unable or not willing to complete follow-up visits and examination for the duration of the study;- Subjects with life expectancy ≤ 1 year per investigator's medical judgement;
• Women of childbearing potential who are, or plan to become, pregnant during the time of the study (assessment per investigator's discretion);