ArcticLine Feasibility Study

Exclusion Criteria

• •Longstanding persistent AF, defined as continuous AF greater than 12 month duration
• •Left atrial diameter greater than 5.0 cm
• •Active systemic infection
• •History of thromboembolic event within the past 6 months or evidence of intracardiac thrombus at the time of the procedure
• •Prior left atrial ablation attempt, with exception of:
• •* Any pulmonary vein isolation attempt to treat AF, or
• •* Successful ablation to treat Wolff-Parkinson White syndrome
• •History of left atrial tachycardia
• •History of cardiac ablation within 90 days of planned clinical study procedure
• •Planned concomitant ventricular ablation
• •Cryoglobulinemia
• •Structural heart disease of clinical significance including:
• •* NYHA Class IV Heart Failure
• •* Diagnosed with NYHA Class III Heart Failure for more than six months at time of the study ablation procedure
• •* LVEF less than 35%
• •* Any cardiac surgery (e.g. CABG) within 3 months of the ablation procedure
• •* Any mechanical heart valve, prior aortic or tricuspid valve replacement (e.g. valvotomy, valve replacement), or tricuspid valve repair
• •* Severe mitral valve regurgitation or stenosis
• •* Significant congenital anomaly or anatomy unable to accommodate device
• •Prior surgical maze procedure
• •Unstable angina
• •Myocardial infarction within 3 months of the ablation procedure
• •Presence of primum or secundum atrial septal defect
• •Anomalous pulmonary venous return
• •Prior surgery for congenital heart disease, including atrial septal defect repair
• •Hypertrophic cardiomyopathy with LV septal wall thickness \>1.5 cm
• •Uncontrolled hyperthyroidism
• •Thrombocytosis, thrombocytopenia (including history of heparin-induced thrombocytopenia)
• •Severe comorbidity or poor general physical/mental health that, in the opinion of the investigator, will not allow the subject to be a good study candidate
• •History of blood clotting or bleeding abnormalities
• •Contraindication to all anticoagulation (e.g. novel oral anticoagulants, heparin or warfarin)
• •Pregnant, nursing or planning to become pregnant during study duration
• •Enrollment in another clinical trial without prior approval from Medtronic
• •Presence or use of left atrial appendage closure device
• •Presence of or planned implantation of a pacemaker, implantable cardiac defibrillator, implantable loop recorder or cardiac resynchronization device with permanent lead placement
• •Pre-existing hemidiaphragmatic paralysis
• •Life expectancy less than one year
• •Known drug or alcohol dependency
• •Existing pulmonary vein stent(s)