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Abbott's Trial To Assess New Therapy Option For People At Risk Of Stroke

Abbott (ABT) said that the U.S. Food and Drug Administration has approved a new trial designed to assess its Amplatzer Amulet Left Atrial Appendage Occluder for people with atrial fibrillation or AF - a condition in which the normal rhythm of the heart's upper chambers is disrupted and becomes erratic - who are at risk of stroke.

The CATALYST trial is the first-ever clinical trial comparing the effectiveness of a left atrial appendage (LAA) closure device to a newer class of blood thinners, known as non-vitamin K antagonist oral anticoagulant (NOAC) drugs, which are currently the standard treatment option for AF.

Atrial Fibrillation is the most common sustained cardiac arrhythmia, with the prevalence in the U.S. projected to increase to 12.1 million by 2030.

The global, multicenter 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 randomize 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.

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