STOP AF First Post-Approval Study

Study Overview
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Brief Summary
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The STOP AF First PAS is a prospective, global, multi-center, observational trial.

Detailed Description
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The STOP AF First Post Approval Study (PAS) is a sub-study to the Cryo Global Registry. The STOP AF First PAS is a prospective, global, multi-center, observational trial. The purpose of the study is to describe long-term clinical performance and safety data in the recurrent symptomatic paroxysmal AF population treated with Arctic Front™ and Freezor™ MAX Families of cardiac cryoablation catheters (hereafter referred to as Arctic Front™ Cardiac Cryoablation Catheter System) as an alternative to antiarrhythmic drug therapy as an initial rhythm control strategy. This PAS is a condition of the pre-market approval order (P100010/S110) by the U.S. Food and Drug Administration.

Official Title
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STOP AF First Post-Approval Study, an Addendum to the Cryo Global Registry

Conditions
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Paroxysmal Atrial Fibrillation

Intervention / Treatment
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* Device: Arctic Front™ Cardiac Cryoablation Catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has been diagnosed with symptomatic paroxysmal AF Subject is ≥ 18 years of age or minimum age as required by local regulations Planned pulmonary vein isolation (PVI) procedure using the commercially available Arctic Front™ cardiac cryoablation catheter System at least 7 calendar days post study enrollment to allow for pre-ablation baseline data collection from sensor device Willing to comply with study requirements and give informed consent (defined as legally effective, documented confirmation of a subject's voluntary agreement to participate in this clinical study) or authorization per institution and geographical requirements Exclusion Criteria: History of AF treatment with class I or III antiarrhythmic drug (AAD), including sotalol, with the intention to prevent an AF recurrence. However, patients pretreated with above AAD for less than 7 days prior to planned PVI procedure or with the intention to convert an AF episode are allowed. Subject has had a prior atrial ablation (except for cavo-tricuspid isthmus (CTI) ablation for AFL) Subject is enrolled in a concurrent study that has not been approved for concurrent enrollment by the global study manager Subject with exclusion criteria required by local law

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Arctic Front™ Cardiac Cryoablation Catheter|Pulmonary vein isolation will be performed with the Arctic Front™ cardiac cryoablation catheter system|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from Atrial Fibrillation (AF) /Atrial Flutter (AFL) /Atrial Tachycardia (AT) | Estimate the 36-month freedom from Atrial Fibrillation (AF) /atrial flutter (AFL) /Atrial Tachycardia (AT) recurrence using the Arctic Front™ cardiac cryoablation catheter System. | 36 months | 
| Freedom from Primary Safety Events | Estimate primary safety Adverse Event (AE) rates for cryoablation using the Arctic Front™ cardiac cryoablation catheter System through 12-months. | 12 months |