Irrigated Ablation System Evaluation for Atrial Fibrillation (AF)
NCT ID: NCT01056328
Last Updated: 2019-02-26
Study Results
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View full resultsBasic Information
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COMPLETED
NA
324 participants
INTERVENTIONAL
2010-02-28
2013-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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St. Jude Medical Cardiac Ablation System
SJM Irrigated Cardiac Ablation System
Irrigated ablation catheter
FDA approved Open Irrigated Radio Frequency Ablation System
FDA approved Open Irrigated RF Ablation System
Irrigated ablation catheter
Interventions
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SJM Irrigated Cardiac Ablation System
Irrigated ablation catheter
FDA approved Open Irrigated RF Ablation System
Irrigated ablation catheter
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Responsible Party
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Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Arizona Arrhythmia Consultants/Scottsdale Healthcare
Scottsdale, Arizona, United States
Good Samaritan Hospital
Los Angeles, California, United States
University of Californai, San Diego Medical Center
San Diego, California, United States
Colorado Cardiac Alliance
Colorado Springs, Colorado, United States
Diagnostic Cardiology Associates, P.A.; St. Vincents Medical Center
Jacksonville, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
Emory University Hospital, Midtown
Emory, Georgia, United States
University of Kansas Hospital
Kansas City, Kansas, United States
Washington Adventist Hospital
Takoma Park, Maryland, United States
Spectrum Health
Grand Rapids, Michigan, United States
MAHI, Saint Luke's Hospital
Kansas City, Missouri, United States
NYU Langone Medical Center
New York, New York, United States
Mount Sinai Hospital
New York, New York, United States
University of Rochester
Rochester, New York, United States
University Hospitals Case Medical Center
Cleveland, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
The Ohio State University Medical Center
Columbus, Ohio, United States
Doylestown Hospital
Doylestown, Pennsylvania, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Centennial Medical Center
Nashville, Tennessee, United States
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, United States
Baylor Heart & Vascular Hospital
Dallas, Texas, United States
The Methodist Hospital Research Institute
Houston, Texas, United States
Intermountain Medical Center
Salt Lake City, Utah, United States
University of Virginia Health System
Charlottesville, Virginia, United States
Inova Fairfax Hospital / Inova Heart and Vascular Institute
Falls Church, Virginia, United States
Sunybrook Health Sciences Centre
Toronto, Ontario, Canada
Severance Hospital
Seoul, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Countries
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Other Identifiers
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90030928
Identifier Type: -
Identifier Source: org_study_id
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