POLARx Cardiac Cryoablation System Post Market Clinical Follow-up study

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 120

Inclusion Criteria

1. Subjects indicated for the treatment of AF with the cryoablation system
according to current and future Guidelines and system indications for use;
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 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

1. Any known contraindication to an AF ablation or anticoagulation, including
those listed in the instructions for use;
2. Subjects with indication for treatment of AF that is not according to
current and future Guidelines and system indications for use;
3. Atrial fibrillation 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 myxoma, LA thrombus or intracardiac mural thrombus;
6. Previous cardiac surgery (e.g. ventriculotomy or atriotomy, CABG, PTCA,
stent procedure) within 90 days prior to enrollment;
7. Implantable cardiac device procedures (e.g. PM, ICD, CRT) within 30 days
prior to enrollment;
8. Implanted Left Atrial Appendage Closure device prior to the index procedure;
9. Interatrial baffle, closure device, patch, or patent foramen ovale (PFO)
occluder;

10. Subjects with severe valvular disease OR with a prosthetic - mechanical or
biological - heart valve (not including valve repair and annular rings);

11. Presence of any pulmonary vein stents;
12. Active systemic infection;
13. Vena cava embolic protection filter devices and/ or known femoral thrombus;
14. Any previous history of cryoglobulinemia;
15. History of blood clotting or bleeding disease;
16. Any prior history of documented cerebral infarct, TIA or systemic embolism
(excluding a post-operative deep vein thrombosis (DVT)) <= 180 days prior to
enrollment;
17. Subjects who are hemodynamically unstable;
18. The subject is unable or not willing to complete follow-up visits and
examination for the duration of the study;

19. Life expectancy <= 1 year per investigator*s opinion;

20. Women of childbearing potential who are, or plan to become, pregnant during
the time of the study (method of assessment upon investigator*s discretion);

21. Unrecovered/unresolved Adverse Events from any previous invasive Procedure;

22. 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.