polarx™ cardiac cryoablation system post market clinical study (polar smart)

Conditions: Paroxysmal Atrial Fibrillation

Summary: 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).

Eligibility criteria:
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.