NCT04226547

Amplatzer Amulet LAAO vs. NOAC

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,650 (estimated)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atrial Fibrillation
• Stroke
• Bleeding

Interventions

Type	Name	Description
DEVICE	Left Atrial Appendage Occlusion (Amplatzer Amulet LAA Occluder)	Implantation of an Amplatzer Amulet left atrial appendage occluder
DRUG	Non-Vitamin K Oral Antagonists	Initiation or continuation of a NOAC drug

Timeline

• Start date: 2020-07-07
• Primary completion: 2029-01-01
• Completion: 2031-04-01
• First posted: 2020-01-13
• Last updated: 2026-02-10

Locations

127 sites across 16 countries: United States, Australia, Canada, Czechia, Denmark, France, Germany, Hong Kong, Italy, Japan, Lithuania, Netherlands, Poland, Spain, Switzerland, United Kingdom

Regulatory

• FDA-regulated device study