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