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Trial launches for next-generation LAA occlusion device for stroke prevention in patients with AF
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St. Jude Medical announced it has launched a trial for its second-generation left atrial appendage occluder.
The device (Amplatzer Amulet) is used to close the LAA, which, in patients with nonvalvular atrial fibrillation, can be the source of stroke-causing blood clots, according to a press release from the company.
The trial will take place at 100 sites in the U.S. and 50 sites internationally. Patients enrolled will be randomly assigned to receive either the Amplatzer Amulet occluder or an FDA-approved LAA closure device (Watchman, Boston Scientific), according to the release.
“There’s a real need within the United States medical community for a [LAA] occluder that addresses a wider range of complex patient anatomies,” Dhanunjaya Lakkireddy, MD, FACC, FHRS, professor and the director of the Center for Excellence in Atrial Fibrillation and Complex Arrhythmias at the University of Kansas, Kansas City, said in the release. “The Amulet device has been used successfully in Europe, and I see this [Investigational Device Exemption] trial as the right step toward providing patients with [AF] the optimal level of care to further reduce the risk of stroke.”
According to the release, the new device is offered in eight sizes and has a longer lobe and waist than the first-generation device, allowing for easier and more stable placement and potentially leading to shorter procedure times.
Disclosure: Lakkireddy reports consulting for Biosense Webster and St. Jude Medical; serving on an advisory board for Atricure, Lifetech and SentreHEART; and speaking for Boehringer Ingelheim, Biotronik, Janssen and Pfizer.