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ACTIVE NOT RECRUITING
NCT05997446

Amulet™ ADVANCE LAA

Sponsor: Abbott Medical Devices

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

610

Start Date

2023-07-12

Completion Date

2027-06

Last Updated

2025-10-01

Healthy Volunteers

No

Interventions

DEVICE

Left atrial appendage occlusion (LAAO)

Implantation of an Amplatzer Amulet left atrial appendage occluder

Locations (16)

Arizona Arrhythmia Research

Phoenix, Arizona, United States

Arkansas Heart Hospital

Little Rock, Arkansas, United States

Baptist Medical Center

Jacksonville, Florida, United States

Usman R. Siddiqui, MD

Winter Park, Florida, United States

PERC - O'Fallon

O'Fallon, Illinois, United States

Kansas City Cardiac Arrhythmia Research Foundation

Overland Park, Kansas, United States

Cardiovascular Research Institute of Kansas

Wichita, Kansas, United States

Providence Hospital

Southfield, Michigan, United States

Bryan Heart

Lincoln, Nebraska, United States

CHI Health Creighton University Medical Center-Bergan Mercy

Omaha, Nebraska, United States

New York University Hospital

New York, New York, United States

Pinnacle Health System

Mechanicsburg, Pennsylvania, United States

Trident Medical Center

Charleston, South Carolina, United States

Vanderbilt Heart & Vascular Institute

Nashville, Tennessee, United States

Baylor All Saints Medical Center at Fort Worth

Fort Worth, Texas, United States

Heart Rhythm Associates

Shenandoah, Texas, United States