Abbott Announces Historic Device Trial in AFib Patients at Risk of Stroke

The future of stroke treatment could look very different depending on the results of a historic device trial for the Amplatzer™ Amulet™ Left Atrial Appendage Occluder that seeks to become an alternative to treatment with non-vitamin K oral anticoagulants, according to a press release from Abbott.

With recent approval from the US Food and Drug Administration (FDA), the CATALYST trial is set to become the first US clinical trial comparing the effectiveness of a left atrial appendage (LAA) closure device to NOACs for patients with atrial fibrillation (AFib) who are at risk of a stroke.

"A device that can address a significant structural issue of the heart via a minimally invasive procedure would be a significant step forward for patients with atrial fibrillation eligible for long-term NOAC therapy," said Vivek Reddy, MD, director of Cardiac Arrhythmia Services for The Mount Sinai Hospital in New York and the principal investigator for the CATALYST trial, in Abbott’s press release. "This study is an extremely important step in assessing the Amplatzer Amulet as an effective non-prescription drug alternative for patients with AF who are at an increased risk for ischemic stroke."

A global, multicenter trial designed to randomize up to 2650 subjects across more than 150 sites and seeks to compare the effectiveness of the Amplatzer Amulet LAA Occluder to NOACs as an alternative treatment option for patients with AFib.

The device is designed to reduce the risk of stroke by giving physicians the ability to permanently “seal off” the LAA after insertion via a minimally invasive incision in the leg—Abbott hopes the device could help mitigate the risk of bleeding events medication expenses, medication compliance, and other issues seen with NOAC use in clinical practice, according to their release.

"The CATALYST trial has the potential to provide data for the Amplatzer Amulet LAA Occluder that could change clinical practice by eliminating a lifetime need for blood thinners — reinforcing our mission of helping people live better lives through better health,” said Neil Moat, MD, chief medical officer of Abbott’s structural heart business.

Abbott pointed out the Amplatzer Amulet device received the CE Mark approval in 2013 and is available in countries that recognize the CE Mark, but the device is currently for investigational use only in the US.