Study Results
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View full resultsBasic Information
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COMPLETED
NA
186 participants
INTERVENTIONAL
2017-03-02
2019-08-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment Arm
Subjects enrolled and treated with Arctic Front Advance Cardiac CryoAblation Catheter
Arctic Front Advance Cardiac CryoAblation Catheter
Cryoablation
Interventions
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Arctic Front Advance Cardiac CryoAblation Catheter
Cryoablation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Failure or intolerance of at least one Class I or III antiarrhythmic drug
* Age 18 or older (or older than 18 if required by local law)
Exclusion Criteria
* Prior left atrial ablation or surgical procedure (including left atrial appendage closures)
* Presence or likely implant of a permanent pacemaker, biventricular pacemaker, loop recorder, or any type of implantable cardiac defibrillator (with or without biventricular pacing function) within 12 months
* Presence of any pulmonary vein stents
* Presence of any pre-existing pulmonary vein stenosis
* Pre-existing hemidiaphragmatic paralysis
* Presence of any cardiac valve prosthesis
* +3 and +4 mitral valve regurgitation or stenosis
* Any cardiac surgery, myocardial infarction, percutaneous coronary intervention (PCI) / percutaneous transluminal coronary angioplasty (PTCA) or coronary artery stenting which occurred during the 3 month interval preceding the consent date
* Unstable angina
* New York Heart Association (NYHA) Class III or IV congestive heart failure and/or documented left ventricular ejection fraction (LVEF) less than or equal to 35% measure by acceptable cardiac testing (e.g. Transthoracic echocardiogram (TTE))
* Primary pulmonary hypertension
* Rheumatic heart disease
* Thrombocytosis, thrombocytopenia
* Any condition contraindicating chronic anticoagulation
* Active systemic infection
* Hypertrophic cardiomyopathy
* Cryoglobulinemia
* Uncontrolled hyperthyroidism
* Any cerebral ischemic event (strokes or transient ischemic attacks (TIAs)) which occurred during the 6 month interval preceding the consent date
* Any woman known to be pregnant or breastfeeding, or any woman of child bearing potential who is not on a reliable form of birth regulation method or abstinence
* Life expectancy less than one year
* Current or anticipated participation in any other clinical trial of a drug, device or biologic during the duration of the study not pre-approved by Medtronic
* Known allergies or hypersensitivities to adhesives
* Known drug or alcohol dependency
* Unwilling or unable to comply fully with study procedures and follow-up
18 Years
ALL
No
Sponsors
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Medtronic Cardiac Ablation Solutions
INDUSTRY
Responsible Party
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Principal Investigators
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Hugh Calkins, MD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Vivek Reddy, MD
Role: PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Locations
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Banner-University Medical Center Phoenix
Phoenix, Arizona, United States
Colorado Heart and Vascular
Lakewood, Colorado, United States
Medical Center of the Rockies
Loveland, Colorado, United States
Cardiac Arrhythmia Service
Boca Raton, Florida, United States
Saint Vincent's Medical Center
Jacksonville, Florida, United States
Northwestern University
Chicago, Illinois, United States
NorthShore University Health System
Evanston, Illinois, United States
The Johns Hopkins Hospital
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
St. Luke's Health System
Kansas City, Missouri, United States
Englewood Hospital & Medical Center
Englewood, New Jersey, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Northwell Health (Lenox Hill Hospital and Staten Island University Hospital)
New York, New York, United States
Asheville Cardiology Associates
Asheville, North Carolina, United States
Doylestown Health Cardiology
Doylestown, Pennsylvania, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Baylor Research Institute
Dallas, Texas, United States
Virginia Mason Medical Center
Seattle, Washington, United States
Swedish Medical Center
Seattle, Washington, United States
Victoria Cardiac Arrhythmia Trials
Victoria, British Columbia, Canada
London Health Sciences Centre
London, Ontario, Canada
Institut Universitaire de Cardiologie et de Pneumologie de Québec
Québec, , Canada
Tokyo Medical and Dental University
Bunkyō, Tokyo, Japan
Jikei University Hospital
Tokyo, , Japan
Yokohama City Minato Red Cross Hospital
Yokohama, , Japan
Countries
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References
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Su WW, Reddy VY, Bhasin K, Champagne J, Sangrigoli RM, Braegelmann KM, Kueffer FJ, Novak P, Gupta SK, Yamane T, Calkins H; STOP Persistent AF Investigators. Cryoballoon ablation of pulmonary veins for persistent atrial fibrillation: Results from the multicenter STOP Persistent AF trial. Heart Rhythm. 2020 Nov;17(11):1841-1847. doi: 10.1016/j.hrthm.2020.06.020. Epub 2020 Jun 24.
Provided Documents
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Document Type: Study Protocol: Version 4
Document Type: Study Protocol: Version 5
Document Type: Study Protocol: Version 6
Document Type: Statistical Analysis Plan
Other Identifiers
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STOP Persistent AF
Identifier Type: -
Identifier Source: org_study_id
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