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.
Atrial Fibrillation, Stroke, Bleeding
Left Atrial Appendage Occlusion (Amplatzer Amulet LAA Occluder),
Non-Vitamin K Oral Antagonists
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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