SMART-SF Radiofrequency Ablation Safety Study

Inclusion Criteria:

• Symptomatic paroxysmal atrial fibrillation (AF) who have had at least one AF episodeelectrocardiographically documented within one (1) year prior to enrollment and aphysician's note indicating recurrent, self-terminating AF. Electrocardiographicdocumentation may include, but is not limited to, electrocardiogram (ECG),transtelephonic monitor (TTM), Holter monitor (HM), or telemetry strip

• Failed at least one antiarrhythmic drug (AAD) (class I or III, or atrioventricular (AV) nodal blocking agents such as beta blockers and calcium channel blockers) asevidenced by recurrent symptomatic AF, or intolerable to the AAD

• Age 18 years or older

Exclusion Criteria:

• Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, orreversible or non-cardiac cause

• Previous surgical or catheter ablation for atrial fibrillation

• Amiodarone at any time during the past 3 months

• Any percutaneous coronary intervention (PCI), cardiac surgery, or valvular cardiacsurgical or percutaneous procedure (e.g., ventriculotomy, atriotomy, and valverepair or replacement and presence of a prosthetic valve) within the past 2 months

• Any carotid stenting or endarterectomy

• Coronary artery bypass graft (CABG) surgery within the past 6 months

• AF episodes lasting >7 days

• Documented left atrial (LA) thrombus on imaging

• LA size >50 mm

• Left ventricular ejection fraction (LVEF) < 40%

• Contraindication to anticoagulation (heparin or warfarin)

• History of blood clotting or bleeding abnormalities

• MI within the past 2 months

• Documented thromboembolic event (including transient ischemic attack (TIA)) withinthe past 12 months

• Rheumatic Heart Disease

• Uncontrolled heart failure or New York Heart Association (NYHA) function class IIIor IV

• Awaiting cardiac transplantation or other cardiac surgery within the next 12 months

• Unstable angina

• Acute illness or active systemic infection or sepsis

• Diagnosed atrial myxoma

• Presence of implanted implantable cardioverter defibrillator (ICD)

• Significant pulmonary disease, (eg, restrictive pulmonary disease, constrictive orchronic obstructive pulmonary disease) or any other disease or malfunction of thelungs or respiratory system that produces chronic symptoms

• Significant congenital anomaly or medical problem that in the opinion of theinvestigator would preclude enrollment in this study

• Women who are pregnant (as evidenced by pregnancy test if pre-menopausal)

• Enrollment in an investigational study evaluating another device, biologic, or drug

• Presence of intramural thrombus, tumor or other abnormality that precludes vascularaccess, or manipulation of the catheter

• Presence of a condition that precludes vascular access

• Life expectancy or other disease processes likely to limit survival to less than 6months