POLARx™ Cardiac Cryoablation System Post Market Clinical Study (POLAR SMART)

POLARx™ Cardiac Cryoablation System Post Market Clinical Study POLAR SMART

This is a post-market study collecting real-world clinical data on safety, effectiveness and procedural success of Boston Scientific Cardiac Cryoablation System (POLARx™ System)

The study will collect real-world clinical data on safety, effectiveness and procedural success of Boston Scientific Cardiac Cryoablation System (POLARx™ System) when used to perform pulmonary vein isolation (PVI) in the ablation treatment of De Novo Atrial Fibrillation (AF).

Inclusion Criteria:

1. Subjects indicated for the treatment of AF with the cryoablation system;
2. Subjects who are willing and capable of providing informed consent;
3. Subjects who are willing and capable of participating in all testing associated with this clinical study at an approved clinical investigational center;
4. Subjects who are of legal age to give informed consent specific to the national law.

Exclusion Criteria:

1. Any known contraindication to an AF ablation or anticoagulation, including those listed in the IFU/Tenpubunsyo as legally approved conditions;
2. Any prior LA ablation;
3. AF secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiac cause;
4. Known or pre-existing severe Pulmonary Vein Stenosis;
5. Evidence of cardiac myxoma, LA thrombus or intracardiac mural thrombus;
6. Previous cardiac surgery (e.g. ventriculotomy or atriotomy, CABG, PTCA, PCI, ventricular fistula or atrial incision) and any surgery within 90 days prior to enrollment;
7. Any implanted cardiac device (e.g. PM, ICD, CRT, valve replacement, LAAO, etc) within 90 days prior to enrollment;
8. Any planned OR scheduled cardiac device procedure (e.g. PM, ICD, CRT, valve replacement, LAAO, etc) during and post PVI ablation (during and post-index procedure);
9. Any planned ablation in LA except PVI procedure and roof line ablation;
10. Any planned ablation in ventricles;
11. Subjects undergoing atrial septal defect patch or other surgical procedures at or near the atrial septal defect;
12. Subjects with severe valvular disease OR with a prosthetic - mechanical or biological - heart valve (not including valve repair and annular rings);
13. Presence of any pulmonary vein stents;
14. Subjects with active systemic infection;
15. Subjects that have vena cava embolic protection filter devices and/or known femoral thrombus;
16. Any previous history of cryoglobulinemia;
17. Subjects that are unable to undergo atrium access safely or operate in the atrium as per investigator's medical judgement;
18. Subjects with no vascular access or obstruction of the femoral vein;
19. Subjects with blood coagulation disorders or diseases;
20. Any prior history of documented cerebral infarct, TIA or systemic embolism (excluding a post-operative deep vein thrombosis (DVT)) ≤ 180 days prior to enrollment;
21. Subjects who are hemodynamically unstable;
22. The subject is unable or not willing to complete follow-up visits and examination for the duration of the study;
23. Subjects with life expectancy ≤ 1 year per investigator's medical judgement;
24. Women of childbearing potential who are, or plan to become, pregnant during the time of the study (assessment per investigator's discretion);
25. Subjects with unrecovered/unresolved Adverse Events from any previous invasive procedure;
26. Subjects who are currently enrolled in another investigational study or registry that would directly interfere with POLAR SMART study. Exception 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 for approval.