AMAZE Will Study SentreHeart's Lariat for Ligation of the LAA as Adjunctive Treatment for AF

June 25, 2015—SentreHeart, Inc. announced that it has received approval for an investigational device exemption from the US Food and Drug Administration (FDA) to begin enrollment in the AMAZE clinical trial of the Lariat suture delivery device for the ligation of the left atrial appendage (LAA) as an adjunctive treatment to ablation in patients with persistent or longstanding persistent atrial fibrillation (AF).

The objective of the AMAZE trial is to demonstrate that using the Lariat for LAA closure, plus pulmonary vein isolation (PVI) catheter ablation will lead to a reduced incidence of recurrent AF compared to PVI alone (the current gold-standard treatment), with a high safety profile. The company noted that recent studies have demonstrated that the Lariat device not only closes the LAA mechanically, but can also isolate electrical activity within the LAA that is a known trigger for AF.

The randomized, controlled AMAZE clinical trial comprises two stages. The overall study plan is to enroll a maximum of 600 persistent or longstanding persistent AF patients who are candidates for PVI catheter ablation at up to 50 centers. The first stage of the AMAZE trial will enroll up to 175 patients at 15 centers.

In the company’s press release, Dhanunjaya Lakkireddy, MD, commented, “The LAA is an important site for AF initiation and persistence, and its exclusion using the Lariat device as an adjunct to conventional ablation could be a major breakthrough in decreasing recurrence in patients with persistent AF. The AMAZE trial is rigorously designed and we believe will further validate the mechanical and electrical isolation benefits of the Lariat device, which has the potential to become a standard of care in treating persistent or longstanding persistent AF.” Dr. Lakkireddy is Professor of Medicine and Director, Center for Excellence in AF and Complex Arrhythmias at the University of Kansas Medical Center in Kansas City, Kansas.

PVI catheter ablation is the standard of care interventional treatment for patients with persistent and longstanding persistent AF; however, not all electrical activity originates from the pulmonary veins. The LAA has been known to play a role in triggering recurrence of AF after treatment with PVI catheter ablation, and is the source of most stroke-causing thrombus in AF patients, advised the company.

James L. Cox, MD, the pioneering surgeon who developed the gold standard Cox-maze procedure as a cure for AF, also commented in SentraHeart’s press release. He said, “The LAA has been accurately termed our most lethal human attachment. The Lariat is the only percutaneous device that can provide the electromechanical isolation of the myocardium of the LAA by devascularization and, when combined with PVI ablation, would seem to be the one most likely to improve catheter ablation outcomes for AF.”