STOP Persistent AF



Status:Active, not recruiting
Conditions:Atrial Fibrillation
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:9/21/2018
Start Date:March 2, 2017
End Date:August 2019

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To demonstrate safety and effectiveness of the Arctic Front Advance™ and Freezor MAX® Cardiac
CryoAblation Catheters for the treatment of drug refractory recurrent symptomatic persistent
atrial fibrillation.


Inclusion Criteria:

- Documentation of symptomatic persistent AF: Defined as having a continuous episode
lasting longer than 7 days but less than 6 months documented by consecutive ECG
recordings OR Defined as having a continuous episode lasting longer than 7 days but
less than 6 months documented by an ECG recording and one doctor note indicating
patient had symptoms consistent with AF

- 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:

- Left atrial diameter > 5.0 cm (anteroposterior)

- 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, PCI / PTCA or coronary artery stenting
which occurred during the 3 month interval preceding the consent date

- Unstable angina

- 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. 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 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
We found this trial at
20
sites
Jacksonville, Florida 32204
Phone: 904-608-0018
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Phone: 617-643-2887
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Boston, MA
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Phone: 615-343-4983
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Asheville, North Carolina 28802
Principal Investigator: Joseph Souza, MD
Phone: 828-274-6000
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1800 Orleans St.
Baltimore, Maryland 21287
410-955-5000
Phone: 410-502-0517
Johns Hopkins Hospital Patients are the focus of everything we do at The Johns Hopkins...
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1200 North Federal Highway
Boca Raton, Florida 33432
Phone: 561-266-0190
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303 East Superior Street
Chicago, Illinois 60611
Phone: 312-695-1806
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Chicago, IL
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3310 Live Oak St
Dallas, Texas 75204
(214) 820-2687
Phone: 214-820-7108
Baylor Research Institute Baylor Research Institute (BRI) is a dedicated research center for finding prevention...
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Doylestown, Pennsylvania 18901
Principal Investigator: Robert Sangrigoli, MD
Phone: 267-893-9700
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Doylestown, PA
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350 Engle St
Englewood, New Jersey 07631
(201) 894-3000
Phone: 201-894-3163
Englewood Hospital and Medical Center Englewood Hospital was incorporated in 1888 as a non-profit, non-sectarian...
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Evanston, Illinois 60201
Phone: 847-570-2906
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Kansas City, Missouri 64111
Phone: 816-931-1883
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Lakewood, Colorado 80228
Phone: 303-595-2619
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Loveland, Colorado 80538
Phone: 970-624-5296
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1428 Madison Ave
New York, New York 10029
(212) 241-6500
Principal Investigator: Marc Miller, MD
Phone: 212-824-8929
Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
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100 East 77th Street
New York, New York 10075
Phone: 212-434-3734
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Phoenix, Arizona 85006
Phone: 602-839-5937
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Seattle, Washington 98101
(888) 862-2737
Phone: 206-341-8907
Virginia Mason Medical Center Established in 1920, Virginia Mason began as an 80-bed hospital with...
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5300 Tallman Ave NW
Seattle, Washington 98122
(206) 782-2700
Phone: 206-320-3917
Swedish Medical Center Since 1910, Swedish has been the region's hallmark for excellence in health...
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Victoria, British Columbia
Phone: 250-595-0400
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