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Left Atrial Appendage Occlusion With The Amplatzer Amulet Device: The Southeast Asia Observational Study

NCT05687591 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 104

Last updated 2026-02-25

No results posted yet for this study

Summary

This is a prospective and retrospective, multicenter observational study where the study is being performed to explore on the short-term and long-term safety and efficacy of LAA occlusion with Amplatzer Amulet Device in Southeast Asia population on a real-world basis.

Conditions

Interventions

DEVICE

Amplatzer Amulet Left Atrial Appendage Occlusion Device

The Amplatzer Amulet LAAO is a transcatheter, self-expanding device intended for use in preventing thrombus embolization from the left atrial appendage. The device is constucted from a nitinol mesh and consists of a lobe and a disc connected by a central waist. Polyester patches are sewn into both the lobe and disc to facilitate occlusion. The lobe has stabilizing wires to improve device placement and retention. The device has threaded screw attachments at each end for connection to the delivery and loading cables. The device has radiopaque markers at each end and at the stabilizing wires that permit visibility during fluoroscopy.

Sponsors & Collaborators

  • InnoSignum

    collaborator INDUSTRY

  • Abbott

    collaborator INDUSTRY

  • Sarawak Heart Centre

    lead OTHER

Principal Investigators

  • Dr. Keng Tat Koh, MBBS · Sarawak Heart Centre

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-01
Primary Completion
2024-12-01
Completion
2024-12-01

Countries

  • Malaysia

Study Locations

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Diseases
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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 NCT05687591 on ClinicalTrials.gov