Abbott has obtained the US Food and Drug Administration (FDA) approval to start a new clinical trial, dubbed CATALYST, to assess its Amplatzer Amulet Left Atrial Appendage Occluder for people who are at risk of stroke.

Atrial Fibrillation (AF) is a condition, in which the normal rhythm of the heart’s upper chambers is disrupted and becomes inconsistent, and people with AF are prone to the risk of stroke.

Abbott structural heart business chief medical officer Neil Moat 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.”

CATALYST is a clinical trial that compares Abbott’s Amplatzer Amulet with NOACs

To reduce the risk of stroke in patients with AF, who are unable to take blood thinners for a long period, physicians perform conventional procedures to prevent blood clots from leaving the left atrial appendage (LAA).

Abbott said that its Amplatzer Amulet device will enable physicians to permanently seal off the LAA, which is delivered to the heart through a small minimally invasive incision in the leg.

The CATALYST is a global, multicentre clinical trial designed to compare the effectiveness of the Abbott Amplatzer Amulet to NOACs as an alternative treatment option in AF patients.

The medical devices firm said that CATALYST is the first clinical trial to compare the effectiveness of an LAA closure device, with non-vitamin K antagonist oral anticoagulant (NOAC) drugs, which are currently used as a standard treatment option for AF.

The Amplatzer Amulet device has been granted CE Mark approval in 2013 and the device is currently available in the US for investigational use only.

CATALYST trial principal investigator Vivek Reddy 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.”