SentreHeart has received approval for an Investigational Device Exemption (IDE) from the US Food and Drug Administration (FDA) to begin enrolment in a clinical study of the Lariat suture delivery device. The randomised, controlled clinical study, known as the AMAZE trial, will evaluate the use of the Lariat device for the ligation of the left atrial appendage (LAA) as an adjunctive treatment to ablation in patients with persistent or long-standing persistent atrial fibrillation.
“The LAA is an important site for atrial fibrillation 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 atrial fibrillation,” says Dhanunjaya Lakkireddy, professor of medicine, director, Center for Excellence in Atrial Fibrillation and Complex Arrhythmias, University of Kansas Medical Center, USA. “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 atrial fibrillation.”
Recent studies have demonstrated that Lariat not only closes the LAA mechanically, but can also isolate electrical activity within the LAA, a known trigger for atrial fibrillation. The objective of the AMAZE trial is to demonstrate that the Lariat for LAA closure, plus pulmonary vein isolation (PVI) ablation will lead to a reduced incidence of recurrent atrial fibrillation compared to PVI alone, with a high safety profile.
The study is comprised of two stages. The overall study plan is to enrol a maximum of 600 persistent or longstanding persistent atrial fibrillation patients who are candidates for PVI catheter ablation at up to 50 centres. The first stage of the AMAZE trial will enrol up to 175 patients at 15 centres.
“The left atrial appendage has been accurately termed our most lethal human attachment,” states James L Cox, the surgeon who developed the gold-standard Cox-maze procedure as a cure for atrial fibrillation. “The Lariat is the only percutaneous device that can provide the electromechanical isolation of the myocardium of the LAA by devascularisation and, when combined with PVI ablation, would seem to be the one most likely to improve catheter ablation outcomes for atrial fibrillation.”
PVI catheter ablation is the standard of care interventional treatment for patients with persistent and longstanding persistent atrial fibrillation; however, not all electrical activity originates from the pulmonary veins. The LAA has been known to play a role in triggering fibrillation recurrence after treatment with PVI catheter ablation, and is the source of most stroke-causing thrombus in atrial fibrillation patients.