Irrigated Ablation System Evaluation for Atrial Fibrillation (AF)

Completed · Not applicable

Conditions studied: Paroxysmal Atrial Fibrillation

In brief

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.

Key facts

Study ID

NCT01056328

Run by

Abbott Medical Devices

People needed

324

Starts

2010-02-01

Expected to finish

2013-01-01

Last updated by the study team

2019-02-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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