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:
- Ligating the left atrial appendage (LAA) with the LARIAT procedure, followed by pulmonary vein isolation (PVI)
- 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.
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.