STOP Persistent AF PAS
Study Details
Study Description
Brief Summary
The STOP Persistent AF Post Approval Study (PAS) is a prospective, global, multicenter, observational trial.
| Condition or Disease | Intervention/Treatment | Phase |
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Detailed 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.
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 persistent 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 commercially available Arctic Front™ Cardiac Cryoablation Catheter System.
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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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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
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Carle Foundation Hospital | Urbana | Illinois | United States | 61801-2500 |
| 2 | Spectrum Health Hospitals | Grand Rapids | Michigan | United States | 49525-6427 |
| 3 | The Lindner Research Center | Cincinnati | Ohio | United States | 45219-2906 |
| 4 | Texas Cardiac Arrhythmia Research Foundation | Austin | Texas | United States | 78705-1852 |
| 5 | Texas Health Research & Education Institute | Dallas | Texas | United States | 75231 |
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 Persistent AF PAS