NAVISTAR® THERMOCOOL® Catheter for the Radiofrequency Ablation of Symptomatic Paroxysmal Atrial Fibrillation

Exclusion Criteria

• •Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.
• •Previous ablation for atrial fibrillation.
• •Patients on amiodarone therapy at any time during the previous six (6) months.
• •AF episodes that last longer than 30 days and are terminated via cardioversion.
• •Any valvular cardiac surgical procedure.
• •CABG procedure within the last 180 days (six months).
• •Awaiting cardiac transplantation or other cardiac surgery within the next 360 days (12 months).
• •Documented left atrial thrombus on imaging (e.g. TEE).
• •History of a documented thromboembolic event within the past one (1) year.
• •Diagnosed atrial myxoma.
• •Presence of 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 60 days (two months).
• •LVEF \< 40%.
• •History of blood clotting or bleeding abnormalities.
• •Contraindication to anticoagulation (i.e. heparin or warfarin).
• •Contraindication to CT/MRA procedure.
• •Life expectancy less than 360 days (12 months).
• •Enrollment in an investigational study evaluating another device or drug.
• •Uncontrolled heart failure or NYHA class III or IV heart failure.
• •Presence of 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