POLARx Cardiac Cryoablation System Study

Inclusion Criteria

• Subjects indicated for the treatment of AF with the cryoablation system according to current and future Guidelines and system indications for use;
• 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;
• Subjects whose age is 18 years or above, or who are of legal age to give informed consent specific to state and national law.

Exclusion Criteria

• Any known contraindication to an AF ablation or anticoagulation, including those listed in the instructions for use;
• Subjects with indication for treatment of AF that is not according to current and future Guidelines and system indications for use;
• Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiac cause;
• Known or pre-existing severe Pulmonary Vein Stenosis;
• Evidence of myxoma, LA thrombus or intracardiac mural thrombus;
• Previous cardiac surgery (e.g. ventriculotomy or atriotomy, CABG, PTCA, stent procedure) within 90 days prior to enrollment;
• Implantable cardiac device procedures (e.g. PM, ICD, CRT) within 30 days prior to enrollment;
• Implanted Left Atrial Appendage Closure device prior to the index procedure;
• Interatrial baffle, closure device, patch, or patent foramen ovale (PFO) occluder;
• 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;
• Active systemic infection;
• Vena cava embolic protection filter devices and/ or known femoral thrombus;
• Any previous history of cryoglobulinemia;
• History of blood clotting or bleeding disease;
• Any prior history of documented cerebral infarct, TIA or systemic embolism (excluding a post-operative deep vein thrombosis (DVT)) ≤ 180 days prior to enrollment;
• Subjects who are hemodynamically unstable;
• The subject is unable or not willing to complete follow-up visits and examination for the duration of the study;
• Life expectancy ≤ 1 year per investigator's opinion;
• Women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment upon investigator's discretion);
• Unrecovered/unresolved Adverse Events from any previous invasive Procedure;
• Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments; each instance must be brought to the attention of the sponsor to determine eligibility.