Overview
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).
Eligibility
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);