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FDA approves new trial of LAA closure device

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The FDA has approved an investigational device exemption to initiate the randomized, controlled AMAZE trial to evaluate use of the Lariat device for left atrial appendage closure as an adjunctive treatment to pulmonary vein isolation in patients with atrial fibrillation, according to a press release from SentreHEART.

Researchers for the AMAZE trial will randomly assign patients with persistent or long-term persistent AF to receive the Lariat device plus pulmonary vein isolation ablation or pulmonary vein isolation ablation alone. The primary outcome will be incidence of recurrent AF, according to the release.

In recent studies, the device demonstrated efficacy in the mechanical closure of the left atrial appendage (LAA) and isolation of electrical activity within the LAA, according to the release.

“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 atrial fibrillation,” Dhanunjaya Lakkireddy, MD, FACC, FHRS, professor of medicine and director of the Center for Excellence in AF and Complex Arrhythmias at the University of Kansas Medical Center, said in the release. “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.”

The multicenter trial will be conducted in two stages at up to 50 centers. Enrollment will include a maximum of 600 patients with persistent or long-term persistent AF who are eligible for pulmonary vein isolation ablation. The first stage is expected to include up to 175 patients at 15 centers, according to the release.

The Lariat Suture Delivery Device is indicated for suture placement and knot tying in surgical procedures where soft tissues are being approximated and/or ligated with a pre-tied polyester suture. SentreHEART received FDA 501(k) clearance for the device in 2006, 2009 and 2014. The device also has CE Mark approval in Europe, according to the press release.

Disclosure: Lakireddy is an investigator for the AMAZE trial.