clinical trial · NCT04226547
Amplatzer Amulet LAAO vs. NOAC
Abbott Medical Devices·N/A·active not recruiting·n = 2,650
Atrial FibrillationStrokeBleedingLeft Atrial Appendage Occlusion (Amplatzer Amulet LAA Occluder)Non-Vitamin K Oral Antagonists
brief 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.
started
Jul 7, 2020
primary completion
Jan 1, 2029
completion
Apr 1, 2031
last updated
Feb 10, 2026
official title
Clinical Trial of Atrial Fibrillation Patients Comparing Left Atrial Appendage Occlusion Therapy to Non-vitamin K Antagonist Oral Anticoagulants
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol