Irrigated Ablation System Evaluation for AF (IRASE-AF)

• Freedom from symptomatic AF during nine months following the blanking period [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
• Confirmation of entrance block in the pulmonary veins [ Time Frame: During the procedure ] [ Designated as safety issue: No ]
• Incidence of adverse events included in the pre-specified composite [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
• Incidence of adverse events included in the pre-specified composite. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

• Documented (> 30 seconds) asymptomatic episodes of AF, AFL or AT after the blanking period [ Time Frame: 12 months ] [ Designated as safety issue: No ]
• Early onset (within 90 days) of SAE/Non-serious AEs and late onset (after 90 days) SAEs [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

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.

• Device: SJM Irrigated Cardiac Ablation System
  Irrigated ablation catheter
• Device: FDA approved Open Irrigated RF Ablation System
  Irrigated ablation catheter

• Experimental: SJM Cardiac Ablation System
  Intervention: Device: SJM Irrigated Cardiac Ablation System
• Active Comparator: FDA approved Open Irriagated RF Ablation System
  Intervention: Device: FDA approved Open Irrigated RF Ablation System

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*

  • Paroxysmal AF is defined as recurrent AF that terminates spontaneously within seven days.

Exclusion Criteria:

• AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
• Previous ablation for AF
• History of any valvular cardiac surgical procedure
• 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 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 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 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