Phase
Condition
Chest Pain
Dysrhythmia
Arrhythmia
Treatment
Arctic Front™ Cardiac Cryoablation Catheter
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subject has been diagnosed with symptomatic paroxysmal AF
Subject is ≥ 18 years of age or minimum age as required by local regulations
Planned pulmonary vein isolation (PVI) procedure using the commercially availableArctic Front™ cardiac cryoablation catheter System.
Willing to comply with study requirements and give informed consent (defined aslegally effective, documented confirmation of a subject's voluntary agreement toparticipate in this clinical study) or authorization per institution andgeographical requirements
Exclusion
Exclusion Criteria:
History of AF treatment with a class I or III antiarrhythmic drug, including sotalol, with the intention to prevent an AF recurrence1
. Subjects under the following conditions may be included in the study:
Temporary treatment with a class I or III AAD (treatment at a therapeutic dose for aperiod of <4 weeks prior to the index PVI procedure)
Recent treatment with a class I or III AAD (within 6 months of the index PVIprocedure) at a dose below therapeutic threshold according to the AHA/ACC/HRSGuideline for the Management of Patients with Atrial Fibrillation
A subject who has received a chemical cardioversion may be included in the study.This includes a chemical cardioversion prior to enrollment and between enrollmentand ablation.
Subject has had a prior atrial ablation (except for cavo-tricuspid isthmus (CTI) ablation for AFL)
Subject is enrolled in a concurrent study that has not been approved forconcurrent enrollment by the global study manager
Subject with exclusion criteria required by local law
Study Design
Study Description
Connect with a study center
Alaska Heart Institute
Anchorage, Alaska 99508
United StatesSite Not Available
Cardiology Associates of Fairfield County
Stamford, Connecticut 06905-5522
United StatesActive - Recruiting
MedStar Washington Hospital Center
Washington, District of Columbia 20010
United StatesActive - Recruiting
BayCare Medical Group Cardiology
Clearwater, Florida 33756
United StatesActive - Recruiting
Heart Rhythm Solutions
Davie, Florida 33328
United StatesActive - Recruiting
Iowa Heart
West Des Moines, Iowa 50266
United StatesActive - Recruiting
Our Lady of the Lake
Baton Rouge, Louisiana 70808
United StatesActive - Recruiting
Southcoast Health System
North Dartmouth, Massachusetts 02747
United StatesActive - Recruiting
Henry Ford Heart & Vascular
Detroit, Michigan 48202-2608
United StatesActive - Recruiting
The Lindner Research Center
Cincinnati, Ohio 45219
United StatesActive - Recruiting
Stern Cardiovascular Foundation
Germantown, Tennessee 38138
United StatesActive - Recruiting
University of Tennessee Methodist Physicians
Memphis, Tennessee 38104-6638
United StatesActive - Recruiting
Texas Health Research and Education Institute
Dallas, Texas 75231
United StatesActive - Recruiting
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