The STOP Persistent AF Post Approval Study (PAS) is a prospective, global, multicenter, observational trial.
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 Type
OBSERVATIONAL
Enrollment
400
Pulmonary vein isolation will be performed with the Arctic Front™ Cardiac Cryoablation Catheter System
Hartford Hospital
Hartford, Connecticut, United States
Cardiology Associates of Fairfield County
Stamford, Connecticut, United States
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.
Time frame: 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.
Time frame: 12 months
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BayCare Medical Group Cardiology
Clearwater, Florida, United States
Heart Rhythms Solutions
Davie, Florida, United States
Carle Foundation Hospital
Urbana, Illinois, United States
Henry Ford Heart & Vascular
Detroit, Michigan, United States
Spectrum Health Hospitals
Grand Rapids, Michigan, United States
The Lindner Research Center
Cincinnati, Ohio, United States
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, United States
Texas Health Research & Education Institute
Dallas, Texas, United States
...and 7 more locations