Amulet™ ADVANCE LAA
NCT05997446 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 610
Last updated 2025-10-01
Summary
This is a prospective, multicenter, observational study intended to characterize real-world outcomes on the commercially available Amulet device in the United States. Over 600 subjects have been enrolled at 16 US clinical sites. Subjects will be followed through 24 months in accordance with each site's standard care practices.
Conditions
Interventions
- DEVICE
-
Left atrial appendage occlusion (LAAO)
Implantation of an Amplatzer Amulet left atrial appendage occluder
Sponsors & Collaborators
-
Abbott Medical Devices
lead INDUSTRY
Principal Investigators
-
Dhanunjaya Lakkireddy, MD · Kansas City Cardiac Arrhythmia Research Foundation
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-07-12
- Primary Completion
- 2027-06-30
- Completion
- 2027-06-30
- FDA Device
- Yes
Countries
- United States
Study Locations
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