STOP AF First Post-Approval Study
Study Details
Study Description
Brief Summary
The STOP AF First PAS is a prospective, global, multi-center, observational trial.
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Detailed Description
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.
Study Design
Outcome Measures
Primary Outcome Measures
- Freedom from Atrial Fibrillation (AF) /Atrial Flutter (AFL) /Atrial Tachycardia (AT) [36 months]
Estimate the 36-month freedom from Atrial Fibrillation (AF) /atrial flutter (AFL) /Atrial Tachycardia (AT) recurrence using the Arctic Front™ cardiac cryoablation catheter System.
- Freedom from Primary Safety Events [12 months]
Estimate primary safety Adverse Event (AE) rates for cryoablation using the Arctic Front™ cardiac cryoablation catheter System through 12-months.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Subject has been diagnosed with symptomatic paroxysmal AF
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Subject is ≥ 18 years of age or minimum age as required by local regulations
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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
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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:
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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.
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Subject has had a prior atrial ablation (except for cavo-tricuspid isthmus (CTI) ablation for AFL)
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Subject is enrolled in a concurrent study that has not been approved for concurrent enrollment by the global study manager
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Subject with exclusion criteria required by local law
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Medtronic Cardiac Rhythm and Heart Failure
Investigators
- Study Director: Brien Neudeck, PharmD, Medtronic Clinical Research Director
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STOP AF First PAS