NCT05997446

Amulet™ ADVANCE LAA

A Real-World Study to Observe Outcomes of Patients Undergoing Closure With the Amplatzer™ Amulet™ Left Atrial Appendage Occluder

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 610 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The ADVANCE LAA study is intended to characterize real-world outcomes of patients receiving the commercially available Amulet device in the United States. The Amulet device is intended to reduce the risk of thrombus embolization from the left atrial appendage (LAA) in patients who have nonvalvular atrial fibrillation (NVAF) and who are at increased risk for stroke and systemic embolism based on CHADS2 or CHA2DS2-VASc scores, are suitable for short-term anticoagulation therapy, and have appropriate rationale to seek a non-pharmacologic alternative to oral anticoagulation, taking into consideration the safety and effectiveness of the device.

Conditions

• Atrial Fibrillation
• Stroke
• Bleeding

Interventions

Type	Name	Description
DEVICE	Left atrial appendage occlusion (LAAO)	Implantation of an Amplatzer Amulet left atrial appendage occluder

Timeline

• Start date: 2023-07-12
• Primary completion: 2027-06-01
• Completion: 2027-06-01
• First posted: 2023-08-18
• Last updated: 2025-10-01

Locations

16 sites across 1 country: United States

Regulatory

• FDA-regulated device study