The STOP AF First PAS is a prospective, global, multi-center, observational trial.
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 Type
OBSERVATIONAL
Enrollment
200
Pulmonary vein isolation will be performed with the Arctic Front™ cardiac cryoablation catheter system
Alaska Heart Institute
Anchorage, Alaska, United States
Cardiology Associates of Fairfield County
Stamford, Connecticut, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
BayCare Medical Group Cardiology
Clearwater, Florida, United States
Heart Rhythm Solutions
Davie, Florida, United States
Iowa Heart
West Des Moines, Iowa, United States
Southcoast Health System
North Dartmouth, Massachusetts, United States
Henry Ford Heart & Vascular
Detroit, Michigan, United States
The Lindner Research Center
Cincinnati, Ohio, United States
Stern Cardiovascular Foundation
Germantown, Tennessee, United States
...and 1 more locations