Overview

Amplatzer Amulet LAAO vs. NOAC

Status:
Recruiting
Trial end date:
2029-04-01
Target enrollment:
Participant gender:
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.
Phase:
N/A
Details
Lead Sponsor:
Abbott Medical Devices