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

UnknownOBSERVATIONAL
Enrollment

100

Participants

Timeline

Start Date

October 1, 2022

Primary Completion Date

October 1, 2024

Study Completion Date

October 1, 2024

Conditions
Atrial Fibrillation
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.

Trial Locations (1)

94300

RECRUITING

Sarawak Heart Centre, Kuching

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

InnoSignum

INDUSTRY

collaborator

Abbott

INDUSTRY

lead

Sarawak Heart Centre

OTHER

NCT05687591 - Left Atrial Appendage Occlusion With The Amplatzer Amulet Device: The Southeast Asia Observational Study | Biotech Hunter | Biotech Hunter