NAVISTAR® THERMOCOOL® Catheter for the Radiofrequency Ablation of Symptomatic Paroxysmal Atrial Fibrillation



Status:Completed
Conditions:Atrial Fibrillation, Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:10/26/2017
Start Date:October 1, 2004
End Date:March 1, 2011

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This trial compares the safety and effectiveness of catheter ablation for PAF with
antiarrhythmic drug therapy. The investigational catheter being studied is the NAVISTAR®
THERMOCOOL® irrigated-tip catheter. At the time of this study, the NAVISTAR® THERMOCOOL®
catheter was FDA-approved for commercial distribution in the U.S. for treating patients with
Type I atrial flutter and drug refractory monomorphic ventricular tachycardia post myocardial
infarction. The catheter was approved for use in Europe for endocardial ablation for treating
cardiac arrhythmias.


You may be eligible to participate in this study if you: Have failed to respond to drug
treatment for your AFib, or find the side effects of your medication intolerable.

Inclusion Criteria

- Patients with symptomatic PAF who have had three (3) AF episodes in the six (6) months
prior to randomization, one of which must be documented. Documentation may include
electrocardiogram (ECG), transtelephonic monitor (TTM), Holter monitor (HM), or
telemetry strip.

- Failure of at least one AAD for PAF [class I or III or AV nodal blocking agents such
as beta blockers (BB) and calcium channel blockers (CCB)] as evidenced by recurrent
symptomatic PAF, or intolerable side effects due to AAD.

- Signed Patient Informed Consent Form.

- Age 18 years or older.

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

Exclusion Criteria

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

- Previous ablation for atrial fibrillation.

- Patients on amiodarone therapy at any time during the previous six (6) months.

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

- Any valvular cardiac surgical procedure.

- CABG procedure within the last 180 days (six months).

- Awaiting cardiac transplantation or other cardiac surgery within the next 360 days (12
months).

- Documented left atrial thrombus on imaging (e.g. TEE).

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

- Diagnosed atrial myxoma.

- Presence of implanted ICD.

- Significant pulmonary disease, (e.g. restrictive pulmonary disease, constrictive or
chronic obstructive pulmonary disease) or any other disease or malfunction of the
lungs or respiratory system that produces chronic symptoms.

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

- 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.

- Myocardial infarction within the previous 60 days (two months).

- LVEF < 40%.

- History of blood clotting or bleeding abnormalities.

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

- Contraindication to CT/MRA procedure.

- Life expectancy less than 360 days (12 months).

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

- Uncontrolled heart failure or NYHA class III or IV heart failure.

- Presence of intramural thrombus, tumor or other abnormality that precludes catheter
introduction or manipulation.

- Presence of a condition that precludes vascular access.

- Left atrial size ≥ 50 mm
We found this trial at
14
sites
3535 Olentangy River Rd
Columbus, Ohio 43214
(614) 566-5000
Riverside Methodist Hospital Serving central Ohio since 1892, Riverside Methodist Hospital is consistently ranked one...
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Columbus, OH
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3300 Gallows Road
Falls Church, Virginia 22042
(703) 776-4001
Inova Fairfax Hospital Inova Fairfax Hospital, Inova's flagship hospital, is an 833-bed, nationally recognized regional...
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Falls Church, VA
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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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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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Baltimore, MD
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Burlington, Massachusetts 01805
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Burlington, MA
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Charleston, SC
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Columbus, OH
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Greenbrae, California 94904
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Greenbrae, CA
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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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Maywood, IL
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New York, New York 10025
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New York, NY
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601 E Rollins St
Orlando, Florida 32803
(407) 303-5600
Florida Hospital Florida Hospital is one of the country
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Orlando, FL
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Philadelphia, PA
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1100 Allied Drive
Plano, Texas 75093
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Plano, TX
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715 Rua Napoleão de Barros
Sao Paulo, 04024
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Sao Paulo,
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