This study is a prospective, multicenter, randomized (2:1) controlled study 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.
This study will be conducted in two stages:
- Limited Early Stage (Stage 1): up to 175 subjects at up to 15 sites
- Pivotal Stage (Stage 2): up to 600 subjects at up to 50 sites All patients from both
stages will be included in the primary analysis.