SMART-SF Radiofrequency Ablation Safety Study

Inclusion Criteria

• Symptomatic paroxysmal atrial fibrillation (AF) who have had at least one AF episode electrocardiographically documented within one (1) year prior to enrollment and a physician's note indicating recurrent, self-terminating AF. Electrocardiographic documentation 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) as evidenced by recurrent symptomatic AF, or intolerable to the AAD
• Age 18 years or older

Exclusion Criteria

• Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or reversible 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 cardiac surgical or percutaneous procedure (e.g., ventriculotomy, atriotomy, and valve repair 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)) within the past 12 months
• Rheumatic Heart Disease
• Uncontrolled heart failure or New York Heart Association (NYHA) function class III or 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 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 (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 vascular access, 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 6 months