Amulet™ ADVANCE LAA

NCT05997446 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 610

Last updated 2025-10-01

No results posted yet for this study

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05997446 on ClinicalTrials.gov