AMAZE TRIAL

WHAT IS THE PURPOSE OF THIS STUDY?

The aim of the aMAZE Trial is to determine if the combination of 2 percutaneous procedures—Left Atrial Appendage (LAA) ligation and Pulmonary Vein Isolation (PVI)—may treat persistent or longstanding persistent atrial fibrillation more effectively than PVI alone. Non-randomized studies using similar criteria and patient population to the aMAZE Trial demonstrated a 66% improvement for the LARIAT + PVI versus PVI only.1

The aMAZE Trial is presently enrolling in select U.S. Centers.
Trial Site Locator: http://amazetrial.com/physician-locator

ABOUT THE TRIAL

The trial is a prospective, multicenter, randomized controlled study. Patients will be divided into 2 groups. Each group will receive one of the following treatments:

  1. Ligating the left atrial appendage (LAA) with the LARIAT procedure, followed by pulmonary vein isolation (PVI)
  2. PVI only

The LARIAT device is currently cleared by the U.S. Food and Drug Administration (FDA) for use in general surgery for soft-tissue closure but has not been well studied for closing the LAA in Afib patients also receiving catheter ablation. Therefore, it is investigational for this specific purpose.2

Suneet Mittal, MD – Director, Electrophysiology Laboratory, The Valley Hospital

1 Lakkireddy D, Mahankali AS, Kanmanthareddy A, et al. Left atrial appendage ligation and ablation for persistent atrial fibrillation (The LAALA-AF Registry). JACCCEP. 2015;1(3):153-160. http://electrophysiology.onlinejacc.org/article.aspx?articleid=2299813
2 Lee RJ, Lakkireddy D, Mittal S, et al. Percutaneous alternative to the Maze procedure for the treatment of persistent or long-standing persistent atrial fibrillation (aMAZE trial): rationale and design. Am Heart J. 2015;170(6):1184-1194. http://www.ncbi.nlm.nih.gov/pubmed/26678640