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Study of an investigational device for Atrial fibrillation
In response to the COVID pandemic, Scripps Health has temporarily suspended enrollment for all clinical trials. Exceptions will exist for trials with curative intent, life-saving treatment or when no standard of care exists. For questions, please call Scripps Office for the Protection of Research Subjects at 858-678-6402.
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.