STOP AF First Post-Approval Study
Start Date
4/28/2022
Completion Date
4/1/2028
Summary
The STOP AF First PAS is a prospective, global, multi-center, observational trial.
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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Arctic Front™ Cardiac Cryoablation Catheter
Conditions
Locations
Alaska Heart Institute
Anchorage, Alaska 99508
United States
Cardiology Associates of Fairfield County
Stamford, Connecticut 06905-5522
United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia 20010
United States
BayCare Medical Group Cardiology
Clearwater, Florida 33756
United States
Heart Rhythm Solutions
Davie, Florida 33328
United States
Iowa Heart
West Des Moines, Iowa 50266
United States
Our Lady of the Lake
Baton Rouge, Louisiana 70808
United States
Southcoast Health System
North Dartmouth, Massachusetts 02747
United States
Henry Ford Heart & Vascular
Detroit, Michigan 48202-2608
United States
The Lindner Research Center
Cincinnati, Ohio 45219
United States
Stern Cardiovascular Foundation
Germantown, Tennessee 38138
United States
University of Tennessee Methodist Physicians
Memphis, Tennessee 38104-6638
United States
Texas Health Research and Education Institute
Dallas, Texas 75231
United States