CATALYST clinical trial : FDA approves Abbott’s trial of Amplatzer Amulet device in AF
Abbott has been granted approval from the US Food and Drug Administration (FDA) for the CATALYST clinical trial to assess its Amplatzer Amulet Left Atrial Appendage Occluder for people with atrial fibrillation (AF).
According to the US medical device company, the CATALYST trial is the first-ever clinical trial that will compare the effectiveness of a left atrial appendage (LAA) closure device to a newer class of blood thinners, called non-vitamin K antagonist oral anticoagulant (NOAC) drugs, which are presently the standard treatment option for atrial fibrillation.
Abbott said that the Amplatzer Amulet device, which enables physicians to permanently seal off the left atrial appendage, will be delivered to the heart by making a small minimally invasive incision in the leg.
The CATALYST trial will randomly group up to 2,650 subjects at 150 clinical trial sites across the world to study if sealing off the left atrial appendage with the Amplatzer Amulet device can be a viable alternative to a lifetime of the newer blood thinners.
Vivek Reddy – director of Cardiac Arrhythmia Services for The Mount Sinai Hospital in New York and the principal investigator for the CATALYST clinical trial, said: “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.
“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.”
In 2013, the Amplatzer Amulet device was given CE Mark approval. The device has been available in Europe and other countries that recognize CE Mark.
Neil Moat – chief medical officer of Abbott structural heart business said: “We are focused on expanding access to minimally invasive options for structural heart disease through new clinical data.
“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.”