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

Conditions

Diseases of the Cardiovascular System

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.
  • Trial with
    SentreHEART, Inc.
  • Start Date
    10/05/2016
  • End Date
    10/30/2018

I'm interested in volunteering

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 877.978.8348

Trial Image

For more information about this study, contact:

Margaret Leiss

  • Last Updated
    06/22/2018
  • Study HIC
    #1606017873