Study of an investigational device for Atrial fibrillation

COVID-19 update:

In response to the COVID pandemic, Scripps Health has either temporarily suspended or limited enrollment with appropriate precautions for all clinical trials. For questions, please call Scripps Office for the Protection of Research Subjects at 858-678-6402.

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