Left Atrial Appendage Ligation with the LARIAT+® Suture Delivery System as Adjunctive Therapy to Pulmonary Vein Isolation (PVI) for Persistent or Longstanding Persistent Atrial Fibrillation
Principal Investigator: Abdi Rasekh, M.D.
Sponsor: SentreHeart, Inc.
This is a (2:1) randomized controlled trial to evaluate the safety and effectiveness of the LARIAT System to percutaneously isolate and ligate the left atrial appendage from the left atrium as an adjunct to planned pulmonary vein isolation (PVI) catheter ablation in the treatment of subjects with symptomatic persistent or longstanding persistent atrial fibrillation.
Main Inclusion Criteria:
- Documented diagnosis of symptomatic persistent or longstanding persistent non-valvular atrial fibrillation
- Failed at least one Class I or III antiarrhythmic drug (AAD)
Main Exclusion Criteria:
- Prior epicardial or endocardial atrial fibrillation ablation procedure
- LA diameter > 6 cm as measured by computerized tomography
To find out more about the study, please see aMAZE Trial.