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
Alaska Heart Institute
Anchorage 5879400, Alaska 5879092 99508
United StatesSite Not Available
Cardiology Associates of Fairfield County
Stamford, Connecticut 06905-5522
United StatesSite Not Available
Cardiology Associates of Fairfield County
Stamford 4843564, Connecticut 4831725 06905-5522
United StatesActive - Recruiting
MedStar Washington Hospital Center
Washington, District of Columbia 20010
United StatesSite Not Available
MedStar Washington Hospital Center
Washington D.C. 4140963, District of Columbia 4138106 20010
United StatesActive - Recruiting
BayCare Medical Group Cardiology
Clearwater, Florida 33756
United StatesSite Not Available
Heart Rhythm Solutions
Davie, Florida 33328
United StatesSite Not Available
BayCare Medical Group Cardiology
Clearwater 4151316, Florida 4155751 33756
United StatesActive - Recruiting
Heart Rhythm Solutions
Davie 4152820, Florida 4155751 33328
United StatesActive - Recruiting
Iowa Heart
West Des Moines, Iowa 50266
United StatesSite Not Available
Iowa Heart
West Des Moines 4881346, Iowa 4862182 50266
United StatesActive - Recruiting
Our Lady of the Lake
Baton Rouge, Louisiana 70808
United StatesSite Not Available
Our Lady of the Lake
Baton Rouge 4315588, Louisiana 4331987 70808
United StatesActive - Recruiting
Southcoast Health System
North Dartmouth, Massachusetts 02747
United StatesSite Not Available
Southcoast Health System
North Dartmouth 4945601, Massachusetts 6254926 02747
United StatesActive - Recruiting
Henry Ford Heart & Vascular
Detroit, Michigan 48202-2608
United StatesSite Not Available
Henry Ford Heart & Vascular
Detroit 4990729, Michigan 5001836 48202-2608
United StatesActive - Recruiting
The Lindner Research Center
Cincinnati, Ohio 45219
United StatesSite Not Available
The Lindner Research Center
Cincinnati 4508722, Ohio 5165418 45219
United StatesActive - Recruiting
Stern Cardiovascular Foundation
Germantown, Tennessee 38138
United StatesSite Not Available
University of Tennessee Methodist Physicians
Memphis, Tennessee 38104-6638
United StatesSite Not Available
Stern Cardiovascular Foundation
Germantown 4624601, Tennessee 4662168 38138
United StatesActive - Recruiting
University of Tennessee Methodist Physicians
Memphis 4641239, Tennessee 4662168 38104-6638
United StatesActive - Recruiting
Texas Health Research and Education Institute
Dallas, Texas 75231
United StatesSite Not Available
Texas Health Research and Education Institute
Dallas 4684888, Texas 4736286 75231
United StatesActive - Recruiting

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