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Amplatzer Amulet LAAO vs. NOAC — CATALYST  

Stroke Clinical Trial

Official title:
Clinical Trial of Atrial Fibrillation Patients Comparing Left Atrial Appendage Occlusion Therapy to Non-vitamin K Antagonist Oral Anticoagulants

Clinical Trial Summary

The objective of this trial is to evaluate the safety and effectiveness of the Amulet LAA occluder compared to NOAC therapy in patients with non-valvular AF at increased risk for ischemic stroke and who are recommended for long-term NOAC therapy. The clinical investigation is a prospective, randomized, multicenter active control worldwide trial. Subjects will be randomized in a 1:1 ratio between the Amulet LAA occlusion device ("Device Group") and a commercially available NOAC medication ("Control Group"). The choice of NOAC in the Control Group will be left to study physician discretion.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04226547
Study type Interventional
Source Abbott Medical Devices
Contact CATALYST Study Team
Phone (408) 845-0536
Email catalyststudy@abbott.com
Status Recruiting
Phase N/A
Start date July 7, 2020
Completion date August 2030
View Details
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