STOP Persistent AF PAS

Study Overview
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Brief Summary
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The STOP Persistent AF Post Approval Study (PAS) is a prospective, global, multicenter, observational trial.

Detailed Description
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The STOP Persistent AF Post Approval Study (PAS) is a sub-study to the Cryo Global Registry. The PAS is a prospective, global, multicenter, observational trial. The purpose of the PAS is to describe long-term clinical performance and safety data in the Persistent AF population treated with Arctic Front™ and Freezor™ MAX Families of Cardiac Cryoablation Catheters (hereafter referred to as Arctic Front™ Cardiac Cryoablation Catheter System). This PAS is a condition of the Pre-Market Approval order (P100010/S098) by the U.S. Food and Drug Administration. Up to 400 subjects will be enrolled to ensure 355 are treated. A minimum of 50% of patients will be enrolled and treated in the US. The follow-up duration for this post-approval study will be 36-months.

Official Title
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STOP Persistent AF Post-Approval Study, a Sub-study to the Cryo Global Registry

Conditions
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Persistent Atrial Fibrillation

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has been diagnosed with persistent AF. Subject is ≥ 18 years of age or minimum age as required by local regulations. Planned pulmonary vein isolation (PVI) procedure using commercially available Arctic Front™ Cardiac Cryoablation Catheter System. 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: 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 System|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 |