Clinical Evaluation of the Blazer Open-Irrigated Ablation Catheter for the Treatment of Paroxysmal Atrial Fibrillation

Exclusion Criteria

• •Have any of the following heart conditions within 90 days prior to enrollment:
• •* New York Heart Association (NYHA) Class III or IV
• •* Left ventricular ejection fraction (LVEF) \<35%
• •* Left atrial (LA) diameter \>5.5 cm
• •* Unstable angina or ongoing myocardial ischemia
• •* Transmural myocardial infarction (MI)
• •Congenital structural heart disease that increases the risk of ablation or precludes catheter placement
• •Undergone any left atrial catheter or surgical ablation
• •Have had a coronary intervention, cardiac surgery, or other cardiac ablation within 90 days prior to enrollment
• •Had \>1 AF episode lasting greater than 7 days, with no episodes having lasted greater than 30 days, within the past year
• •Subjects regularly prescribed amiodarone therapy during the 120 days prior to enrollment
• •Contraindication to anticoagulation therapy
• •Creatinine \>2.5mg/dl or creatinine clearance \<30mL/min within 90 days (3 months) prior to enrollment
• •Prosthetic mitral or tricuspid heart valves
• •Confirmed cardiac thrombus within 30 days (1 month) prior to enrollment
• •Implanted pacemaker, ICD, or CRT leads within 180 days (6 months) prior to enrollment
• •History of CVA, TIA or PE within 180 days (6 months) prior to enrollment
• •Left atrial appendage closure device
• •Any other significant uncontrolled or unstable medical condition (e.g. sepsis, acute metabolic illness, end stage COPD)
• •Enrolled in any concurrent clinical trial without documented pre-approval from BSC
• •Women who are pregnant or plan to become pregnant within the course of their participation in the investigation
• •Life expectancy ≤ 2 years (730 days) per physician opinion