NAVISTAR® THERMOCOOL® Catheter Post Approval Registry



Status:Completed
Conditions:Atrial Fibrillation
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:10/19/2018
Start Date:September 1, 2009
End Date:January 5, 2018

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NAVISTAR® THERMOCOOL® Catheter for the Radiofrequency Ablation of Drug Refractory Recurrent Symptomatic Paroxysmal Atrial Fibrillation - Post Approval Registry

The purpose of this registry is to provide additional corroborative short-term safety and
long-term safety data for the NAVISTAR THERMOCOOL and NAVISTAR EZ STEER THERMOCOOL catheters
in the treatment of symptomatic Paroxysmal Atrial Fibrillation (PAF).

This registry is a prospective, multi-center, non-randomized post approval evaluation
comprised of two (2) registry arms with independent hypotheses. The registry arms are defined
as; Arm 1) physicians who perform greater than or equal to 50 atrial fibrillation ablation
procedures per year and Arm 2) physicians who perform less than 50 atrial fibrillation
ablation procedures per year. Subjects with drug refractory recurrent symptomatic PAF will be
considered for this post approval registry. This registry will be conducted at up to 40
centers in a minimum of 381 evaluable subjects. The devices are currently FDA approved for
commercial distribution under PMA #P030031/S11.

Inclusion Criteria:

Candidates for this registry must meet ALL of the following criteria:

- Patients with drug refractory recurrent symptomatic PAF who have had three (3) AF
episodes in the six (6) months prior to enrollment and one AF episode documented
within the one (1) year prior to enrollment. Documentation may include
electrocardiogram (ECG), transtelephonic monitor (TTM), Holter monitor (HM), or
telemetry strip.

- Failure of at least one AAD for AF (class I or III or AV nodal blocking agent such as
beta blockers and calcium channel blockers) as evidenced by recurrent symptomatic PAF,
or intolerable side effects.

- Age 18 years or older.

- Able and willing to comply with all pre-, post- and follow-up testing and
requirements.

- Signed Patient Informed Consent Form.

Exclusion Criteria:

Candidates will be excluded from the registry if any of the following conditions apply:

- Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or reversible
or non-cardiac cause.

- AF episodes that last longer than 30 days and are terminated via cardioversion.

- CABG procedure within the last six (6) months.

- Awaiting cardiac transplantation or other cardiac surgery.

- Documented left atrial thrombus on imaging (i.e., TEE, ICE, CT, or MRA).

- History of a documented thromboembolic event within the past one (1) year.

- Diagnosed atrial myxoma.

- Significant congenital anomaly or medical problem that in the opinion of the
investigator would preclude enrollment in this registry.

- Women who are pregnant (by history of menstrual period or pregnancy test if the
history is considered unreliable).

- Acute illness or active systemic infection or sepsis.

- Unstable angina.

- Uncontrolled heart failure.

- Myocardial infarction within the previous two (2) months.

- History of blood clotting or bleeding abnormalities.

- Contraindication to anticoagulation (i.e. heparin or warfarin).

- Life expectancy less than 12 months.

- Enrollment in an investigational study evaluating another device or drug.

- Presence of intramural thrombus, tumor or other abnormality that precludes catheter
introduction or manipulation.
We found this trial at
23
sites
Milwaukee, Wisconsin 53215
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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601 Elmwood Avenue
Rochester, New York 14642
(585) 275-2100
Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
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Rochester, NY
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Austin, TX
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Austin, Texas 78756
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Baltimore, Maryland 20742
(301) 405-1000
University of Maryland As a globally-connected university offering a world-class education, the University of Maryland...
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Baltimore, MD
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1800 Orleans St.
Baltimore, Maryland 21287
410-955-5000
Johns Hopkins Hospital Patients are the focus of everything we do at The Johns Hopkins...
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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Detroit, MI
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Fairfax, Virginia 22031
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Jacksonville, Florida 32204
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1740 Nicholasville Rd
Lexington, Kentucky 40503
(859) 260-6100
Central Baptist Hospital Located in Lexington, Ky., Baptist Health Lexington offers some of the most...
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2160 South 1st Avenue
Maywood, Illinois 60153
(888) 584-7888
Loyola University Medical Center Loyola University Health System is committed to excellence in patient care...
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Minneapolis, Minnesota 55426
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New York, New York 10025
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1100 N. Lindsay
Oklahoma City, Oklahoma 73104
(405) 271-4000
University of Oklahoma The OU Health Sciences Center is composed of seven health-related colleges located...
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Richmond, Virginia 23298
(804) 828-0100
Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
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Silver Spring, Maryland 20903
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Silver Spring, MD
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