POLARx Post Approval Study (POLARx PAS)

Korábbi kezelés

• Any prior LA ablation;

Más betegség

• Any known contraindication to an AF ablation or anticoagulation, including those listed in the IFU as legally approved conditions;
• Subjects with severe valvular disease OR with a prosthetic - mechanical or biological - heart valve (not including valve repair and annular rings);
• Subjects with active systemic infection;

Egyéb

• Known or pre-existing severe PV Stenosis;
• Presence of any pulmonary vein stents;
• 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);

• 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;