Irrigated Ablation System Evaluation for Atrial Fibrillation (AF)

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