Study of an investigational device for Atrial fibrillation

Trial ID:
IRB-16-6730
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.

Inclusion Criteria

  • Have persistent non-valvular Atrial Fibrillation
  • Have Life expectancy over 1 year
  • Meet all other eligibility criteria

Exclusion 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%

Additional Info

  • Patients will be randomly assigned to receive either the LARIAT device plus catheter ablation or catheter ablation only.

Contact Info:

  • Heather Catchpole
  • catchpole.heather@scrippshealth.org
  • 858-824-4248