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