Irrigated Ablation System Evaluation for Atrial Fibrillation (AF)



Status:Completed
Conditions:Atrial Fibrillation
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:2/28/2019
Start Date:February 2010
End Date:January 2013

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Irrigated Ablation System Evaluation for AF

The purpose of this study is to test the safety and effectiveness of an Irrigated Ablation
System for the treatment of symptomatic paroxysmal atrial fibrillation.


Inclusion Criteria:

- Age 18 years or older

- Signed Patient Informed Consent Form

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

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

- Subjects with symptomatic paroxysmal atrial fibrillation (PAF)*

- PAF is defined as recurrent atrial fibrillation (AF) that terminates
spontaneously within seven days.

Exclusion Criteria:

- Atrial fibrillation (AF) secondary to electrolyte imbalance, thyroid disease, or
reversible or non-cardiac cause

- Previous ablation for AF

- History of any valvular cardiac surgical procedure

- Coronary artery bypass grafting (CABG) procedure within the last six months

- Awaiting cardiac transplantation or other cardiac surgery within the next 12 months

- Left atrial thrombus

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

- Diagnosed atrial myxoma

- An implanted implantable cardioverter defibrillator (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 two months

- Left ventricular ejection fraction (LVEF) <40% as determined by pre-procedure
transthoracic echocardiogram (TTE)

- History of blood clotting or bleeding abnormalities

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

- Contraindication to computed tomography/magnetic resonance angiography (CT/MRA)
procedure

- Life expectancy less than 12 months

- Enrollment in an investigational study evaluating another device or drug

- Uncontrolled heart failure or New York Heart Association (NYHA) class III or IV heart
failure

- An 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 as determined by pre-procedure TTE
We found this trial at
28
sites
1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Birmingham, AL
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Cleveland, OH
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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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Philadelphia, PA
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60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
University of Rochester The University of Rochester is one of the country's top-tier research universities....
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Rochester, NY
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1 Tampa General Cir
Tampa, Florida 33606
(813) 844-7000
Tampa General Hospital In a diverse city known for its rich culture and beautiful beaches,...
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Austin, TX
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1215 Lee St
Charlottesville, Virginia 22903
(434) 924-0211
University of Virginia Health System UVA Health System includes a 604-bed hospital, level I trauma...
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Cleveland, OH
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Colorado Springs, Colorado 80907
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Columbus, OH
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Dallas, TX
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Doylestown, Pennsylvania 18901
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Emory, Georgia 30308
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Falls Church, VA
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Grand Rapids, Michigan 49503
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Houston, TX
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Jacksonville, FL
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Kansas City, Kansas 66160
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Kansas City, Missouri 64111
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Los Angeles, California 90017
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Nashville, Tennessee 37203
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New York, New York 10016
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New York, New York 10029
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Salt Lake City, Utah 84157
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Takoma Park, Maryland 20912
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Toronto,
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