POLARx Cardiac Cryoablation System Study

Study Overview
=================
Brief Summary
-----------------
This is a Post Market Clinical Follow-up (PMCF) study designed to establish the continued safety and effectiveness profile of the Boston Scientific Cardiac Cryoablation System after receiving CE mark.

Detailed Description
-----------------
The study will provide information on real-world usage of the Boston Scientific Cardiac Cryoablation System when used to perform pulmonary vein isolation (PVI) for the ablation treatment of atrial fibrillation (AF), according to the current and future guidelines and product indications for use. This may include but not limited to: repeated ablations to treat AF, concomitant or delayed adjunctive ablation strategies with other products and use of different diagnostic products to validate the results such as 3D mapping systems.

Official Title
-----------------
POLARx Cardiac Cryoablation System Post Market Clinical Follow-up Study

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Device: Boston Scientific Cardiac Cryoablation System


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Treatment patients<br>Subjects indicated for the treatment of AF with the cryoablation system according to current and future Guidelines and system indications for use | Device: Boston Scientific Cardiac Cryoablation System<br>* cryoablation of atrial fibrillation consisting in electrical isolation of the pulmonary veins<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety event free rate | freedom from procedure or device related adverse events after intervention | 12 months | 
| failure free rate | includes freedom from failure of intervention or more than one repeated procedures within 90 days post index procedure, or documented atrial fibrillation, new onset atrial flutter or atrial tachycardia between 91 days and 365 days post procedure | 12 months |