aMAZE Study: LAA Ligation Adjunctive to PVI for Persistent or Longstanding Persistent Atrial Fibrillation (aMAZE)

What is the purpose of this trial?

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 35 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.

Participation Guidelines

Ages: 18 - 80 years

Gender: Both


SentreHEART, Inc.

Dates: 10/06/2016 - 10/31/2018

Last Updated: 10/08/2016

Study HIC#: 1606017873

Get Involved

For more information about this study, contact:
Bemen Habashi
+1 203-737-1330
bemen.habashi@yale.edu

If you would prefer to contact a member of the Help us Discover team about this trial and other similar trials, please email helpusdiscover@yale.edu or call 1-877-978-8348.

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