Abbott has announced approval from the US Food and Drug Administration (FDA) for the CATALYST trial to examine its Amplatzer Amulet device compared to non-vitamin K oral anticoagulants to lower stroke and bleeding risks for patients with atrial fibrillation.
A company statement says that the CATALYST trial is the first-ever clinical trial comparing the effectiveness of a left atrial appendage (LAA) closure device to a non-vitamin K antagonist oral anticoagulant (NOAC) drug, which are currently the standard treatment option for AF.
The global, multicentre CATALYST trial will compare the effectiveness of the Abbott Amplatzer Amulet to NOACs as an alternative treatment option in an expanded population of AF patients. Blood thinners, first warfarin and now NOACs, are commonly the first-line therapy to reduce the risk of ischemic stroke – the most common type of all stroke – in patients with AF who are at an increased risk. However, risk of bleeding events, medication expenses, narrow therapeutic window, patient lifestyle, and medication compliance often limit blood thinner effectiveness in clinical practice. The CATALYST trial will randomise up to 2,650 subjects at 150 sites worldwide to assess whether sealing off the LAA with the Amulet device may be a viable alternative to a lifetime of these newer blood thinners.
“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,” Vivek Reddy (Mount Sinai Hospital, New York, USA) the principal investigator for the CATALYST trial, says. In the 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.”
The Amplatzer Amulet device received CE mark approval in 2013 and is available in Europe and other countries that recognize CE mark. At this time, the device is for investigational use only in the USA.