Irrigated Ablation System Evaluation for Atrial Fibrillation (AF)

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