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Study of an investigational device for Atrial fibrillation
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Douglas Gibson, M.D.
This trial will examine if using the LARIAT Suture Delivery System plus catheter ablation is safe and effective for treating patients with atrial fibrillation.
Have persistent non-valvular Atrial Fibrillation
Have Life expectancy over 1 year
Meet all other eligibility criteria
Have had a prior procedure involving opening of the pericardium; for example, heart transplantation or valve surgery
Have had a prior epicardial or endocardial AF ablation procedure;
Have had a stroke within the past 3 months
Have NYHA Class IV heart failure symptoms
Have a history of right heart failure
Have a myocardial infarction (MI) within 3 months prior to the planned study intervention
Have Chronic renal insufficiency
Have Left Ventricular Ejection Fraction less than 30%
Patients will be randomly assigned to receive either the LARIAT device plus catheter ablation or catheter ablation only.