Officials at Abbott (NYSE:ABT) think data from the new Catalyst trial could alter clinical practice, eliminating the need for some people with atrial fibrillation to take blood thinners for the rest of their life in order to prevent strokes. The randomized trial will include up to 2,650 subjects at 150 sites worldwide and will compare the effectiveness of the Amplatzer Amulet compared with non-vitamin K antagonist oral anticoagulant (NOAC) drugs.
“We are focused on expanding access to minimally invasive options for structural heart disease through new clinical data,” Dr. Neil Moat, Abbott’s structural heart business CMO, said in a news release.
Some people with AF end up experiencing blood pooling in the left atrial appendage (LAA) — a small naturally occurring pocket connected to the heart’s upper left chamber. The blood pooling can potentially cause clot formation and a resulting stroke.
To reduce ischemic stroke risk, doctors have prescribed blood thinners, first warfarin and now NOACs. But the drugs come with their own set of problems: bleeding events, medication compliance and more.
Delivered to the heart in a minimally invasive procedure, the Amplatzer Amulet permanently “seals off” the LAA.
“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 Dr. Vivek Reddy, director of Cardiac Arrhythmia Services for The Mount Sinai Hospital in New York and the Catalyst trial’s principal investigator.
“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,” Reddy said in a news release.
The Amplatzer Amulet device is already available in the European Union, where it has had a CE Mark since 2013. It is an investigational device in the U.S.